Back to resultsImmunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
Primary Purpose
Rubella, Mumps, Measles
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GSK Biological's investigational vaccine 209762
M-M-R® II (Merck and Co)
Varivax®
Havrix®
Prevnar®
Sponsored by
About this trial
This is an interventional prevention trial for Rubella focused on measuring Measles, Mumps, Rubella, Varicella Vaccine, Children, Immunogenicity, Safety, Humans, Combined Vaccine, Vaccines
Eligibility Criteria
Inclusion Criteria:
- Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination.
- Written informed consent obtained from the parent/guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.
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.
- Concurrently participating 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).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine.
- Previous vaccination against measles, mumps, rubella and/or varicella.
- Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
- History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases.
- Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Hypersensitivity to latex
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures, including febrile seizures.
- Acute disease at the time of enrolment.
- Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Priorix 1 Group
Priorix 2 Group
Priorix 3 Group
MMR-II Group
Arm Description
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Outcomes
Primary Outcome Measures
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Secondary Outcome Measures
Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.
Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).
Anti-measles Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Anti-mumps Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.
Anti-rubella Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Anti-varicella Antibody Concentrations.
Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.
Anti-hepatitis A Virus Antibody Concentrations.
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.
Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
Anti-measles Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Anti-measles Virus Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.
Number of Subjects Reporting Febrile Convulsions
Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.
Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))
Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.
Number of Subjects Reporting Other Rash.
Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Anti-rubella Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Anti-rubella Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Number of Subjects Reporting Fever.
fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.
Number of Subjects With Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling.
Number of Subjects Reporting Medically Attended Visit (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.
Swelling with accompanying general symptoms
Number of Subjects With Solicited General Symptoms.
Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).
NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Antibody titers were expressed as Geometric Mean Titer (GMT).
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Antibody concentrations are expressed as Geometric Mean Titer (GMT).
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)
Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
Anti-mumps Virus Antibody Concentrations (PPD ELISA)
Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00861744
Brief Title
Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
Official Title
A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 3, 2009 (Actual)
Primary Completion Date
July 21, 2010 (Actual)
Study Completion Date
June 18, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine.
The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rubella, Mumps, Measles, Measles-Mumps-Rubella Vaccine
Keywords
Measles, Mumps, Rubella, Varicella Vaccine, Children, Immunogenicity, Safety, Humans, Combined Vaccine, Vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1259 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Priorix 1 Group
Arm Type
Experimental
Arm Description
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Arm Title
Priorix 2 Group
Arm Type
Experimental
Arm Description
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Arm Title
Priorix 3 Group
Arm Type
Experimental
Arm Description
Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Arm Title
MMR-II Group
Arm Type
Active Comparator
Arm Description
Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
Intervention Type
Biological
Intervention Name(s)
GSK Biological's investigational vaccine 209762
Intervention Description
Subcutaneous injection, one dose
Intervention Type
Biological
Intervention Name(s)
M-M-R® II (Merck and Co)
Intervention Description
Subcutaneous injection, one dose
Intervention Type
Biological
Intervention Name(s)
Varivax®
Intervention Description
Subcutaneous injection, one dose
Intervention Type
Biological
Intervention Name(s)
Havrix®
Intervention Description
Intramuscular injection, one dose
Intervention Type
Biological
Intervention Name(s)
Prevnar®
Intervention Description
Intramuscular injection, one dose
Primary Outcome Measure Information:
Title
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.
Description
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Time Frame
At Day 42 after administration of a dose of Priorix vaccine.
Title
Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.
Description
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.
Time Frame
At Day 42 after administration of a dose of Priorix vaccine.
Title
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Description
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Time Frame
At Day 42 after administration of a dose of Priorix vaccine.
Secondary Outcome Measure Information:
Title
Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.
Description
Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).
Time Frame
At Day 42 after administration of a dose of Varivax vaccine.
Title
Anti-measles Virus Antibody Concentrations
Description
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Time Frame
At Day 42 after administration of a dose of Priorix vaccine.
Title
Anti-mumps Virus Antibody Concentrations
Description
Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.
Time Frame
At Day 42 after administration of a dose of Priorix vaccine.
Title
Anti-rubella Virus Antibody Concentrations
Description
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Time Frame
At Day 42 after administration of a dose of Priorix vaccine.
Title
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Description
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Time Frame
At Day 42 after vaccination
Title
Anti-varicella Antibody Concentrations.
Description
Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.
Time Frame
At Day 42 after administration of a dose of Varivax vaccine.
Title
Anti-hepatitis A Virus Antibody Concentrations.
Description
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.
Time Frame
At Day 42 after administration of a dose of Havrix vaccine.
Title
Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.
Description
Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).
Time Frame
At Day 42 after administration of a dose of Havrix vaccine.
Title
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Description
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Time Frame
At Day 0 before vaccination
Title
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Description
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
Time Frame
At 1 year post-vaccination
Title
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Description
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
Time Frame
At 2 years post-vaccination
Title
Anti-measles Virus Antibody Concentrations
Description
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Time Frame
At 2 years post-vaccination
Title
Anti-measles Virus Antibody Concentrations
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
Time Frame
At 1 year post-vaccination
Title
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.
Time Frame
During the 43-day (Days 0-42) post-vaccination period
Title
Number of Subjects Reporting Febrile Convulsions
Description
Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.
Time Frame
During the 43-day (Days 0-42) post-vaccination period
Title
Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))
Description
Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.
Time Frame
At 1 year post-vaccination
Title
Number of Subjects Reporting Other Rash.
Description
Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature
Time Frame
During the 43-day (Days 0-42) post-vaccination period
Title
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)
Description
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.
Time Frame
At 1 year post-vaccination
Title
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Description
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Time Frame
At 1 year post-vaccination
Title
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Description
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Time Frame
At 2 years post-vaccination
Title
Anti-rubella Virus Antibody Concentrations
Description
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Time Frame
At 1 year post-vaccination
Title
Anti-rubella Virus Antibody Concentrations
Description
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
Time Frame
At 2 years post-vaccination
Title
Number of Subjects Reporting Fever.
Description
fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.
Time Frame
During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period
Title
Number of Subjects With Solicited Local Symptoms.
Description
Solicited local symptoms assessed were pain, redness and swelling.
Time Frame
During the 4-day (Days 0-3) post-vaccination period
Title
Number of Subjects Reporting Medically Attended Visit (MAEs)
Description
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time Frame
During the 43-day (Days 0-42) post-vaccination period
Title
Number of Subjects With Unsolicited Adverse Events (AEs).
Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame
During the 43-day (Days 0-42) post-vaccination period
Title
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.
Description
Swelling with accompanying general symptoms
Time Frame
During the 43-day (Days 0-42) post-vaccination period
Title
Number of Subjects With Solicited General Symptoms.
Description
Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Time Frame
During the 15-day (Days 0-14) post-vaccination period
Title
Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).
Description
NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame
From Day 0 to Day 180 after vaccination
Title
Number of Subjects Reporting Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
From Day 0 to Day 180 after vaccination
Title
Number of Subjects Reporting Serious Adverse Events (SAEs).
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.
Time Frame
From Day 180 to Day 730 after vaccination
Title
Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.
Time Frame
From Day 0 to Day 180 after vaccination
Title
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Description
Antibody titers were expressed as Geometric Mean Titer (GMT).
Time Frame
At 1 year post-vaccination
Title
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Description
Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
Time Frame
At 1 year post-vaccination
Title
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Description
Antibody concentrations are expressed as Geometric Mean Titer (GMT).
Time Frame
At 2 years post-vaccination
Title
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Description
Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
Time Frame
At 2 years post-vaccination
Title
Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)
Description
Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.
Time Frame
At 1 year post-vaccination
Title
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Description
Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
Time Frame
At 1 year post-vaccination
Title
Anti-mumps Virus Antibody Concentrations (PPD ELISA)
Description
Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.
Time Frame
At 2 years post-vaccination
Title
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Description
Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
Time Frame
At 2 years post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination.
Written informed consent obtained from the parent/guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.
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.
Concurrently participating 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).
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine.
Previous vaccination against measles, mumps, rubella and/or varicella.
Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases.
Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Hypersensitivity to latex
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures, including febrile seizures.
Acute disease at the time of enrolment.
Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
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
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35401
Country
United States
Facility Name
GSK Investigational Site
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72034
Country
United States
Facility Name
GSK Investigational Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
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
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
GSK Investigational Site
City
Downey
State/Province
California
ZIP/Postal Code
90241
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
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
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
Santa Ana
State/Province
California
ZIP/Postal Code
92701-4607
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
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
GSK Investigational Site
City
Dalton
State/Province
Georgia
ZIP/Postal Code
30721
Country
United States
Facility Name
GSK Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
Facility Name
GSK Investigational Site
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
GSK Investigational Site
City
DeKalb
State/Province
Illinois
ZIP/Postal Code
60115
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
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
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
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21021
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
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
GSK Investigational Site
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
GSK Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89015
Country
United States
Facility Name
GSK Investigational Site
City
Utica
State/Province
New York
ZIP/Postal Code
13502
Country
United States
Facility Name
GSK Investigational Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
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
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
GSK Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
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
East Norriton
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
GSK Investigational Site
City
Rydal
State/Province
Pennsylvania
ZIP/Postal Code
19046
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
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
GSK Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
GSK Investigational Site
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
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
Provo
State/Province
Utah
ZIP/Postal Code
84604
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
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Facility Name
GSK Investigational Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
GSK Investigational Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
GSK Investigational Site
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
GSK Investigational Site
City
Bayamon
ZIP/Postal Code
00959
Country
Puerto Rico
Facility Name
GSK Investigational Site
City
San Germán
ZIP/Postal Code
00683
Country
Puerto Rico
Facility Name
GSK Investigational Site
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD Sharing URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=3669
Citations:
PubMed Identifier
26582873
Citation
Mufson MA, Diaz C, Leonardi M, Harrison CJ, Grogg S, Carbayo A, Carlo-Torres S, JeanFreau R, Quintero-Del-Rio A, Bautista G, Povey M, Da Costa C, Nicholson O, Innis BL. Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12-15 Months. J Pediatric Infect Dis Soc. 2015 Dec;4(4):339-48. doi: 10.1093/jpids/piu081. Epub 2014 Aug 7.
Results Reference
background
PubMed Identifier
28481690
Citation
Berry AA, Abu-Elyazeed R, Diaz-Perez C, Mufson MA, Harrison CJ, Leonardi M, Twiggs JD, Peltier C, Grogg S, Carbayo A, Shapiro S, Povey M, Baccarini C, Innis BL, Henry O. Two-year antibody persistence in children vaccinated at 12-15 months with a measles-mumps-rubella virus vaccine without human serum albumin. Hum Vaccin Immunother. 2017 Jul 3;13(7):1516-1522. doi: 10.1080/21645515.2017.1309486. Epub 2017 May 8.
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
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111870
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111870
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111870
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
111870
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
111870
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
111870
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111870
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age
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