Back to results

Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

Primary Purpose

Haemophilus Influenzae Type b, Neisseria Meningitidis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine

ActHIB

PedvaxHIB

Pediarix

Prevnar

M-M-R II

Varivax

About this trial

This is an interventional prevention trial for Haemophilus Influenzae Type b focused on measuring Primary and booster vaccination, Neisseria meningitidis, Hib disease, Meningococcal vaccine, Meningococcal disease, Children, Immunogenicity, Safety, Infants

Eligibility Criteria

6 Weeks - 15 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. Written informed consent obtained from the parent or guardian of the subject. Healthy subjects as established by medical history and clinical examination before entering into the study. Born after 36 weeks gestation. Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment. Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine. Exclusion Criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s). (Synagis® [palivizumab, MedImmune], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed. Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine. History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease. Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required). History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. Major congenital defects or serious chronic illness. History of any neurologic disorders or seizures. Acute disease at time of enrollment. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, subjects should not be administered M-M-R II and Varivax if any of these criteria apply: History of measles, mumps, rubella or varicella. Previous vaccination against measles, mumps, rubella or varicella. Hypersensitivity to any component of the vaccines, including gelatin or neomycin. Patients receiving immunosuppressive therapy. Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. Individuals with primary and acquired immunodeficiency states. Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. Individuals with active tuberculosis. Acute disease at time of booster vaccination.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Menhibrix A Group

Menhibrix B Group

Menhibrix C Group

Menhibrix Group

ActHIB Group

Arm Description

Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.

Outcomes

Primary Outcome Measures

Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers

Titers were expressed as Geometric Mean Titers (GMTs) This analysis occured on the cohort 1 : Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers

Titers are expressen as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

hSBA-MenC Antibody Titers

Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

hSBA-MenY Antibody Titers

Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)

The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. Co-administration with MMR-II vaccine

Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)

The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50 Co-administration with MMR-II vaccine.

Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)

The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL. Co-administration with MMR-II vaccine.

Number of Subjects With Anti-varicella Titer Equal to or Above 1:5

The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5. Co-administration with Varivax vaccine.

Secondary Outcome Measures

Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-D and Anti-T Antibody Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)

Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-HBS Antibody Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-International units per milliliter (mIU/mL) Results are stratified by the presence or absence of a birth dose of hepatitis B vaccine. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-poliovirus Types 1, 2 and 3 Titers

Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values

Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-PSC and Anti-PSY Antibody Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values

Anti-PRP antibody cut-off values assessed were >=0.15 microgram per milliliter (µg/mL) and >=1.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values

Anti-PRP Antibody Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

Anti-PRP Antibody Concentrations

Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values

hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8 The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values

hSBA-MenC/Y antibody cut-off values assessed were >=1:4 and >=1:8. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

hSBA-MenC and hSBA-MenY Antibody Titers

Titres are expressed as Geometric Mean Titers (GMTs). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

hSBA-MenC and hSBA-MenY Antibody Titers

Titers are expressed as Geometric Mean Titers (GMTs) The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 microgram per milliliter (µg/mL) and >=2.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL. The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

Anti-PSC and Anti-PSY Antibodies Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per milliliter (µg/mL). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

Anti-PSC and Anti-PSY Antibody Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL). The analysis was performed on the cohort 3 (Non-US Safety and Immunogenicity): Cohort 3 was to include the subjects enrolled at 1 center in Mexico. Only descriptive immunogenicity results were reported for this cohort. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value

Anti-PRP antibody cut-off values assessed were >=0.15 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-PRP Antibody Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL). This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values

hSBA-MenC and hSBA-MenY antibody cut-off values assessed were >=1:4 and >=1:8. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

Anti-PSC and anti-PSY antibody cut-off values assessed were >=0.3 µg/mL and >=2.0 µg/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-PSC and Anti-PSY Antibody Concentrations

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-PRP Antibody Concentrations

Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)

The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-measles Antibody Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in milli-international units per milliliter (mIU/mL). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values

Anti-mumps antibody cut-off values assessed were >=28 estimated dose 50 (ED50) and >=51 ED50. The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 24 ED50. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-mumps Antibody Titers

Titers are expressed as Geometric Mean Titers (GMTs). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titers below 24 ED50. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)

The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-rubella Antibody Concentrations

Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in international units per milliliter (IU/mL). The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 4 IU/mL. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-varicella Titer Equal to or Above 1:40

The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-rubella antibody concentrations below 1:5 This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Anti-varicella Antibody Titers

Titers are expressed as Geometric Mean Titers (GMTs) The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-varicella antibody titers below 1:5 This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40

anti-H1N1, anti-H3N2 and anti-influenza-B (anti B) antibody were measured by hemagglutination inhibition assay (HIA), in subjects who received 2 doses of influenza vaccine within the same influenza season of which at least one dose is concomitant with the study vaccine. For the purposes of this study, concomitant administration of influenza vaccine was defined as administration within 28 days before to 7 days after administration of study vaccines. This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based.

Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit

Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).

Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit

Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).

Number of Subjects Reporting Solicited Local and General Symptoms

Solicited local symptoms assessed were pain, redness and swelling. Solicited genral symptoms assessed were fever, irritability/fussiness, drowsiness and loss of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.

Number of Subjects Reporting Solicited Local and General Symptoms

Solicited local symptoms assessed were pain, redness, swelling and an increase in limb circumference. Solicited general symptoms assessed were fever, irritability/fussiness, drowsiness and lost of appetite. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)

Increased circumferential swelling defined as either swelling with a diameter of >50 mm or a >50 mm increase in the circumference of the mid-limb when compared to the baseline (pre-vaccination) measurement, or any diffuse swelling that interferes with or prevents everyday activities (for example, active playing, eating, sleeping).

Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination

Symptoms assessed were fever, rash/exanthem, parotid/salivary gland swelling, and any suspected signs of meningism including febrile convulsions. Fever is defined as temperature (rectal or axillary/tympanic) equal to or above 38.0°C.

Number of Subjects Reporting Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.

Number of Subjects Reporting Serious Adverse Events (SAEs)

Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Number of Subjects Reporting Rash

Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.

Number of Subjects Reporting Rash

Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.

Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.

Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits

Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Full Information

NCT ID

NCT00289783

First Posted

February 9, 2006

Last Updated

July 26, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00289783

Brief Title

Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

Official Title

A Phase III, Randomized, Multinational Study, Double-blinded for the Immunogenicity and Consistency Evaluation of 3 Hib-MenCY-TT Vaccine Lots and Single-blinded and Controlled for the Evaluation of Safety and Immunogenicity of GSK Biologicals' Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

February 22, 2006 (undefined)

Primary Completion Date

August 27, 2007 (Actual)

Study Completion Date

February 26, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.

Detailed Description

The subjects from this study will participate in one of three cohorts: US Safety and Immunogenicity (Cohort 1): All immunogenicity analyses in the primary and booster phases will be evaluated in this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases. Safety Only (Cohort 2): Only safety objectives will be assessed in the primary and booster phases for this cohort. Non-US Safety and Immunogenicity (Cohort 3): Only descriptive immunogenicity results in the primary and booster phases will be reported for this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases. Treatment allocation: Primary phase: Subjects will be randomized with balanced allocation (1:1:1:1) to 1 of the 4 treatment groups and with a stratification according to the cohort. Assignment to a cohort will be based on study site. Booster phase: Subjects who received Hib-MenCY-TT vaccine in the primary phase will receive a booster dose of Hib-MenCY-TT vaccine. Subjects who received ActHIB in the primary phase will receive a booster dose of PedvaxHIB. During the 3-dose primary vaccination course, co-administration of Prevnar, Synagis, and/or rotavirus vaccine is permitted; co-administration of influenza vaccine is permitted at dose 3. During the booster vaccination, co-administration of Prevnar, hepatitis A vaccine and influenza vaccine is permitted for all subjects in Cohort 1, 2 and 3; and co-administration of measles, mumps, rubella and varicella vaccine is permitted for all subjects in Cohort 2 and 3. The study will be conducted in a double-blind fashion with regard to consistency of the 3 manufacturing lots of Hib-MenCY-TT vaccine and single-blind fashion for Hib-MenCY-TT vaccine versus monovalent Hib vaccine. The parents/guardians will be blinded up to collection of all data pertaining to the period up to one month after booster vaccination. Therefore, the extended safety follow-up after the booster dose will be conducted in an unblinded manner. The person administering the vaccines will ensure that the parent/guardian does not see the vaccine vial used in reconstituting the vaccine. Due to the differences in the presentations of the candidate Hib-MenCY-TT vaccine and control vaccines, it is not possible to blind study personnel who administer the vaccines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Haemophilus Influenzae Type b, Neisseria Meningitidis

Keywords

Primary and booster vaccination, Neisseria meningitidis, Hib disease, Meningococcal vaccine, Meningococcal disease, Children, Immunogenicity, Safety, Infants

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

4441 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Menhibrix A Group

Arm Type

Experimental

Arm Description

Arm Title

Menhibrix B Group

Arm Type

Experimental

Arm Description

Arm Title

Menhibrix C Group

Arm Type

Experimental

Arm Description

Arm Title

Menhibrix Group

Arm Type

Experimental

Arm Description

Arm Title

ActHIB Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine

Intervention Description

3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

Intervention Type

Biological

Intervention Name(s)

ActHIB

Intervention Description

3-dose intramuscular injection at 2, 4 and 6 months of age.

Intervention Type

Biological

Intervention Name(s)

PedvaxHIB

Intervention Description

1 booster dose by intramuscular injection at 12 to 15 months of age.

Intervention Type

Biological

Intervention Name(s)

Pediarix

Other Intervention Name(s)

Infanrix penta

Intervention Description

3-dose intramuscular injection at 2, 4 and 6 months of age.

Intervention Type

Biological

Intervention Name(s)

Prevnar

Intervention Description

3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

Intervention Type

Biological

Intervention Name(s)

M-M-R II

Intervention Description

1 booster dose by subcutaneous injection at 12 to 15 months of age.

Intervention Type

Biological

Intervention Name(s)

Varivax

Intervention Description

1 booster dose by subcutaneous injection at 12 to 15 months of age

Primary Outcome Measure Information:

Title

Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations

Description

Time Frame

One month after primary vaccination

Title

Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers

Description

Time Frame

One month after primary vaccination

Title

Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers

Description

Time Frame

One month after primary vaccination

Title

hSBA-MenC Antibody Titers

Description

Time Frame

Prior to the fourth dose vaccination and 42 days after the fourth dose

Title

hSBA-MenY Antibody Titers

Description

Time Frame

Prior to the fourth dose vaccination and 42 days after the fourth dose

Title

Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

One month after primary vaccination

Title

Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

42 days after the fourth dose

Title

Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

42 days after the fourth dose

Title

Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)

Description

The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. Co-administration with MMR-II vaccine

Time Frame

42 days after the fourth dose

Title

Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

42 days after the fourth dose

Title

Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)

Description

The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50 Co-administration with MMR-II vaccine.

Time Frame

42 days after the fourth dose

Title

Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)

Description

The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL. Co-administration with MMR-II vaccine.

Time Frame

42 days after the fourth dose

Title

Number of Subjects With Anti-varicella Titer Equal to or Above 1:5

Description

The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5. Co-administration with Varivax vaccine.

Time Frame

42 days after the fourth dose

Secondary Outcome Measure Information:

Title

Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

One month after primary vaccination

Title

Anti-D and Anti-T Antibody Concentrations

Description

Time Frame

One month after primary vaccination

Title

Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)

Description

Time Frame

One month after primary vaccination

Title

Anti-HBS Antibody Concentrations

Description

Time Frame

One month after primary vaccination

Title

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

One month after primary vaccination

Title

Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

One month after primary vaccination

Title

Number of Subjects With Anti-poliovirus Types 1, 2 and 3 Equal to or Above 8 Estimated Dose 50 (ED50)

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

One month after primary vaccination

Title

Anti-poliovirus Types 1, 2 and 3 Titers

Description

Time Frame

One month after primary vaccination

Title

Number of Subjects With Antibodies to Neisseria Meningitidis Serogroup C and Y Polysaccharide Capsule (Anti-PSC and Anti-PSY) Concentrations Equal to or Above the Cut-off Values

Description

Time Frame

One month after primary vaccination

Title

Anti-PSC and Anti-PSY Antibody Concentrations

Description

Time Frame

One month after primary vaccination

Title

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values

Description

Time Frame

One month after the primary vaccination course

Title

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Values

Description

Time Frame

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Title

Anti-PRP Antibody Concentrations

Description

Time Frame

One month after the primary vaccination course

Title

Anti-PRP Antibody Concentrations

Description

Time Frame

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Title

Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values

Description

Time Frame

One month after the primary vaccination course

Title

Number of Subjects With hSBA-MenC and hSBA-MenY Titers Equal to or Above the Cut-off Values

Description

Time Frame

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Title

hSBA-MenC and hSBA-MenY Antibody Titers

Description

Time Frame

One month after the primary vaccination course

Title

hSBA-MenC and hSBA-MenY Antibody Titers

Description

Time Frame

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Title

Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

Description

Time Frame

One month after the primary vaccination course

Title

Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

Description

Time Frame

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Title

Anti-PSC and Anti-PSY Antibodies Concentrations

Description

Time Frame

One month after the primary vaccination course

Title

Anti-PSC and Anti-PSY Antibody Concentrations

Description

Time Frame

Prior to the fourth dose vaccination and one month after fourth dose vaccination

Title

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above the Cut-off Value

Description

Time Frame

One month after the primary vaccination course

Title

Anti-PRP Antibody Concentrations

Description

Time Frame

One month after the primary vaccination course and prior to the fourth dose vaccination

Title

Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values

Description

Time Frame

One month after the primary vaccination course

Title

Number of Subjects With Anti-PSC and Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values

Description

Time Frame

Prior to the fourth dose vaccination and 42 days after fourth dose vaccination

Title

Anti-PSC and Anti-PSY Antibody Concentrations

Description

Time Frame

Prior to the fourth dose vaccination and 42 days after fourth dose vaccination

Title

Number of Subjects With Anti-PRP Antibody Concentrations Equal to or Above 0.15 Microgram Per Milliliter (µg/mL)

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

Prior to the fourth dose vaccination and 42 days after fourth vaccination

Title

Anti-PRP Antibody Concentrations

Description

Time Frame

Prior to the fourth vaccination and 42 days after fourth vaccination

Title

Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Concentrations Equal to or Above 1:4

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

Prior to the fourth dose vaccination and 42 days after fourth vaccination

Title

Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 200 Milli-international Units Per Millilitre (mIU/mL)

Description

Time Frame

42 days after fourth vaccination

Title

Anti-measles Antibody Concentrations

Description

Time Frame

42 days after fourth vaccination

Title

Number of Subjects With Anti-mumps Titer Equal to or Above the Cut-off Values

Description

Time Frame

42 days after fourth vaccination

Title

Anti-mumps Antibody Titers

Description

Time Frame

42 days after fourth vaccination

Title

Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 4 International Units Per Millilitre (IU/mL)

Description

Time Frame

42 days after fourth vaccination

Title

Anti-rubella Antibody Concentrations

Description

Time Frame

42 days after fourth vaccination

Title

Number of Subjects With Anti-varicella Titer Equal to or Above 1:40

Description

Time Frame

42 days after fourth vaccination

Title

Anti-varicella Antibody Titers

Description

Time Frame

42 days after fourth vaccination

Title

Number of Subjects With Anti-H1N1, Anti-H3N2 and Anti-influenza-B (Anti B) Antibody Titers Equal to or Above 1:40

Description

Time Frame

Prior to the fourth dose vaccination and one month after the fourth dose vaccination

Title

Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit

Description

Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).

Time Frame

In the 4-day (Day 0-3) follow-up period after primary vaccination course

Title

Number of Subjects Reporting Fever Above 39.5 Degrees Celsius/103.1 Degrees Fahrenheit

Description

Fever is defined as temperature (rectal or axillary/tympanic) above 39.5 degrees Celsius (°C) or 103.1 degrees Fahrenheit (°F).

Time Frame

In the 4-day (Day0-3) follow-up period after the fourth dose

Title

Number of Subjects Reporting Solicited Local and General Symptoms

Description

Time Frame

Within the 4 days (Day 0-3) following each dose of the primary vaccination course

Title

Number of Subjects Reporting Solicited Local and General Symptoms

Description

Time Frame

Within the 4 days (Day 0-3) post-vaccination period following the fourth dose

Title

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Description

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Time Frame

Within 31 days (Day 0-30) following the primary vaccination course

Title

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Description

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Time Frame

Within 31 days (Day 0-30) following the fourth dose

Title

Number of Subjects Reporting Increased Circumferential Swelling at the Injection Limb(s)

Description

Time Frame

Within 4 days (Day 0 to Day 3) after fourth dose vaccination

Title

Number of Subjects Reporting General Symptoms Specific to Measles, Mumps, Rubella and Varicella Vaccination

Description

Time Frame

Within 43 days (Day 0 through Day 42) after vaccination

Title

Number of Subjects Reporting Serious Adverse Events (SAEs)

Description

Time Frame

From Dose 0 through 6 months after the last primary dose or untill administration of the fourth dose

Title

Number of Subjects Reporting Serious Adverse Events (SAEs)

Description

Time Frame

From the fourth dose through the end of the 6-month safety follow-up

Title

Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)

Description

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Time Frame

From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

Title

Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCDs)

Description

NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.

Time Frame

From the fourth dose through the end of the 6-month safety follow-up

Title

Number of Subjects Reporting Rash

Description

Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.

Time Frame

From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

Title

Number of Subjects Reporting Rash

Description

Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.

Time Frame

From the fourth dose through the end of the 6-month safety follow-up

Title

Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

Description

Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

Time Frame

From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

Title

Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits.

Description

Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

Time Frame

From Dose 0 through 6 months after the last primary dose or until administration of the fourth dose

Title

Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits

Description

Emergency room (ER) visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

Time Frame

From the fourth dose through the end of the 6-month safety follow-up

Title

Number of Subjects Reporting Adverse Events Resulting in Physicians (MD) Office Visits

Description

Physicians (MD) office visits were not related to well-child care, vaccination, injury or common acute illness such as upper respiratory tract infections; otitis media, pharyngitis, gastroenteritis.

Time Frame

From the fourth dose through the end of the 6-month safety follow-up

Title

Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL).

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

Prior to the fourth dose vaccination

Title

Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titer Equal to or Above 1:8.

Description

This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.

Time Frame

Prior to the fourth dose vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

15 Months

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

Country

United States

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35235

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85003

Country

United States

Facility Name

GSK Investigational Site

City

Bryant

State/Province

Arkansas

ZIP/Postal Code

72011

Country

United States

Facility Name

GSK Investigational Site

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72202

Country

United States

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

GSK Investigational Site

City

East Artesia

State/Province

California

ZIP/Postal Code

90706

Country

United States

Facility Name

GSK Investigational Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

GSK Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93710

Country

United States

Facility Name

GSK Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

GSK Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93726

Country

United States

Facility Name

GSK Investigational Site

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

GSK Investigational Site

City

Oakland

State/Province

California

ZIP/Postal Code

94609

Country

United States

Facility Name

GSK Investigational Site

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

Facility Name

GSK Investigational Site

City

Rolling Hills Estates

State/Province

California

ZIP/Postal Code

90274

Country

United States

Facility Name

GSK Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

GSK Investigational Site

City

West Covina

State/Province

California

ZIP/Postal Code

91790

Country

United States

Facility Name

GSK Investigational Site

City

Longmont

State/Province

Colorado

ZIP/Postal Code

80501

Country

United States

Facility Name

GSK Investigational Site

City

Norwich

State/Province

Connecticut

ZIP/Postal Code

06360

Country

United States

Facility Name

GSK Investigational Site

City

Cocoa Beach

State/Province

Florida

ZIP/Postal Code

32931

Country

United States

Facility Name

GSK Investigational Site

City

Melbourne

State/Province

Florida

ZIP/Postal Code

332901

Country

United States

Facility Name

GSK Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

GSK Investigational Site

City

Rockledge

State/Province

Florida

ZIP/Postal Code

32955

Country

United States

Facility Name

GSK Investigational Site

City

Nampa

State/Province

Idaho

ZIP/Postal Code

208 463 3126

Country

United States

Facility Name

GSK Investigational Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

GSK Investigational Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50309

Country

United States

Facility Name

GSK Investigational Site

City

Arkansas City

State/Province

Kansas

ZIP/Postal Code

67005

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

GSK Investigational Site

City

Bardstown

State/Province

Kentucky

ZIP/Postal Code

40004

Country

United States

Facility Name

GSK Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

GSK Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40272

Country

United States

Facility Name

GSK Investigational Site

City

Bossier City

State/Province

Louisiana

ZIP/Postal Code

71111

Country

United States

Facility Name

GSK Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

GSK Investigational Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02724

Country

United States

Facility Name

GSK Investigational Site

City

Jamaica Plain

State/Province

Massachusetts

ZIP/Postal Code

02130

Country

United States

Facility Name

GSK Investigational Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49008

Country

United States

Facility Name

GSK Investigational Site

City

Portage

State/Province

Michigan

ZIP/Postal Code

49024

Country

United States

Facility Name

GSK Investigational Site

City

Stevensville

State/Province

Michigan

ZIP/Postal Code

49127

Country

United States

Facility Name

GSK Investigational Site

City

Brainerd

State/Province

Minnesota

ZIP/Postal Code

56401

Country

United States

Facility Name

GSK Investigational Site

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55108

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

GSK Investigational Site

City

North Las Vegas

State/Province

Nevada

ZIP/Postal Code

89025

Country

United States

Facility Name

GSK Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

GSK Investigational Site

City

Ithaca

State/Province

New York

ZIP/Postal Code

14850

Country

United States

Facility Name

GSK Investigational Site

City

New Hartford

State/Province

New York

ZIP/Postal Code

13413

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

GSK Investigational Site

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

GSK Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

GSK Investigational Site

City

Sylva

State/Province

North Carolina

ZIP/Postal Code

28779

Country

United States

Facility Name

GSK Investigational Site

City

Boardman

State/Province

Ohio

ZIP/Postal Code

44512

Country

United States

Facility Name

GSK Investigational Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44121

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

Facility Name

GSK Investigational Site

City

Huber Heights

State/Province

Ohio

ZIP/Postal Code

45424

Country

United States

Facility Name

GSK Investigational Site

City

South Euclid

State/Province

Ohio

ZIP/Postal Code

44121

Country

United States

Facility Name

GSK Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74127

Country

United States

Facility Name

GSK Investigational Site

City

Gresham

State/Province

Oregon

ZIP/Postal Code

97030

Country

United States

Facility Name

GSK Investigational Site

City

Beaver Falls

State/Province

Pennsylvania

ZIP/Postal Code

15010

Country

United States

Facility Name

GSK Investigational Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16501

Country

United States

Facility Name

GSK Investigational Site

City

Greenville

State/Province

Pennsylvania

ZIP/Postal Code

16125

Country

United States

Facility Name

GSK Investigational Site

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033-0850

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19114

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

GSK Investigational Site

City

Sellersville

State/Province

Pennsylvania

ZIP/Postal Code

18960

Country

United States

Facility Name

GSK Investigational Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

GSK Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

GSK Investigational Site

City

Lexington

State/Province

South Carolina

ZIP/Postal Code

29072

Country

United States

Facility Name

GSK Investigational Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79124

Country

United States

Facility Name

GSK Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Facility Name

GSK Investigational Site

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-0188

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78205

Country

United States

Facility Name

GSK Investigational Site

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

GSK Investigational Site

City

Layton

State/Province

Utah

ZIP/Postal Code

84041

Country

United States

Facility Name

GSK Investigational Site

City

Pleasant Grove

State/Province

Utah

ZIP/Postal Code

84062

Country

United States

Facility Name

GSK Investigational Site

City

Saint George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

GSK Investigational Site

City

South Jordan

State/Province

Utah

ZIP/Postal Code

84095

Country

United States

Facility Name

GSK Investigational Site

City

Mechanicsville

State/Province

Virginia

ZIP/Postal Code

23111

Country

United States

Facility Name

GSK Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23510

Country

United States

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98664

Country

United States

Facility Name

GSK Investigational Site

City

La Crosse

State/Province

Wisconsin

ZIP/Postal Code

54601

Country

United States

Facility Name

GSK Investigational Site

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

GSK Investigational Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

GSK Investigational Site

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

GSK Investigational Site

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3053

Country

Australia

Facility Name

GSK Investigational Site

City

Mexico, D.F.

ZIP/Postal Code

06720

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

21806393

Citation

Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.

Results Reference

background

PubMed Identifier

21624883

Citation

Bryant KA, Marshall GS, Marchant CD, Pavia-Ruiz N, Nolan T, Rinderknecht S, Blatter M, Aris E, Lestrate P, Boutriau D, Friedland LR, Miller JM. Immunogenicity and safety of H influenzae type b-N meningitidis C/Y conjugate vaccine in infants. Pediatrics. 2011 Jun;127(6):e1375-85. doi: 10.1542/peds.2009-2992. Epub 2011 May 29.

Results Reference

background

PubMed Identifier

22617844

Citation

Bryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1.

Results Reference

background

Citation

Bryant KA et al. Immune response to measles, mumps, rubella (MMR) and varicella (V) vaccine coadministered with a fourth dose of Haemophilus influenzae type b - Neisseria meningitidis serogroups C and Y - tetanus toxoid conjugate (HibMenCY) vaccine in toddlers. Abstract presented at the Annual meeting of Pediatric Academic Societies (PAS). Vancouver, Canada, 1-4 May 2010.

Results Reference

background

PubMed Identifier

22327493

Citation

Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

103813

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

103813

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

103813

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

103813

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

103813

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103813 are summarised with study 105067 on the GSK Clinical Study Register.

Learn more about this trial

Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

We'll reach out to this number within 24 hrs

Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine

Haemophilus Influenzae Type b, Neisseria Meningitidis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial