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3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age

Primary Purpose

Haemophilus Influenzae Type b, Neisseria Meningitidis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Hib-MenCY-TT vaccine
Hib-MenC-TT vaccine
Menjugate ®
Infanrix penta ®
Infanrix hexa ®
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Haemophilus Influenzae Type b focused on measuring Invasive bacterial disease caused by Hib, Neisseria meningitidis serogroups C & Y

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth. Exclusion Criteria: Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Menhibrix F1/Infanrix-penta Group

Menhibrix F2/Infanrix-penta Group

Menhibrix F3/Infanrix-penta Group

Menitorix/Infanrix-penta Group

Menjugate/Infanrix-hexa Group

Arm Description

Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.

Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.

Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.

Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.

Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.

Outcomes

Primary Outcome Measures

Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8

Secondary Outcome Measures

Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
rSBA-MenC Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
rSBA-MenY Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
Anti-PRP Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL
Anti-PSC Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Anti-PSY Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Anti-tetanus Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.
Number of Seroprotected Subjects for Anti-tetanus Antibodies
Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)
Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
Anti-PRP Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128
rSBA-MenC antibody titre cut-off value assessed was ≥1:128
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128
rSBA-MenY antibody titre cut-off value assessed was ≥1:128
rSBA-MenC Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
rSBA-MenY Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)
Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL
Anti-PSC Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Anti-PSY Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).
Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL
Anti-T Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Anti-diphtheria Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).
Anti-poliovirus Types 1, 2, 3 Antibody Titres
Titres are expressed as geometric mean titres (GMTs)
Number of Seroprotected Subjects for Anti-diphtheria Antibodies
Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL
Number of Seroprotected Subjects for Anti-hepatitis B Antibodies
Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies
Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8
Number of Subjects With Vaccine Response to PT, FHA and PRN
Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling.
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 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 With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling.
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 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.

Full Information

First Posted
August 10, 2005
Last Updated
July 26, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00129116
Brief Title
3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age
Official Title
A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Three Different Formulations of GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups C and Y- Conjugate Vaccine and One Formulation of GSK Biologicals' Haemophilus Influenzae Type B-meningococcal Serogroup C Conjugate Vaccine Each Given Concomitantly With InfanrixTM Penta, Versus MeningitecTM, Given Concomitantly With InfanrixTM Hexa in Infants According to a 2-3-4 Month Schedule
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 1, 2003 (undefined)
Primary Completion Date
December 1, 2003 (Actual)
Study Completion Date
December 16, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.
Detailed Description
Primary & booster vaccination study to evaluate the immuno,reacto & safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C & Y-conjugate vaccine & one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule

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
Invasive bacterial disease caused by Hib, Neisseria meningitidis serogroups C & Y

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Menhibrix F1/Infanrix-penta Group
Arm Type
Experimental
Arm Description
Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Arm Title
Menhibrix F2/Infanrix-penta Group
Arm Type
Experimental
Arm Description
Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Arm Title
Menhibrix F3/Infanrix-penta Group
Arm Type
Experimental
Arm Description
Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Arm Title
Menitorix/Infanrix-penta Group
Arm Type
Experimental
Arm Description
Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Arm Title
Menjugate/Infanrix-hexa Group
Arm Type
Active Comparator
Arm Description
Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
Intervention Type
Biological
Intervention Name(s)
Hib-MenCY-TT vaccine
Intervention Description
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Intervention Type
Biological
Intervention Name(s)
Hib-MenC-TT vaccine
Intervention Description
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Intervention Type
Biological
Intervention Name(s)
Menjugate ®
Intervention Description
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Intervention Type
Biological
Intervention Name(s)
Infanrix penta ®
Other Intervention Name(s)
DTPa-HBV-IPV vaccine
Intervention Description
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Intervention Type
Biological
Intervention Name(s)
Infanrix hexa ®
Other Intervention Name(s)
DTPa-HBV-IPV/Hib vaccine
Intervention Description
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Primary Outcome Measure Information:
Title
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Description
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Time Frame
One month after dose 3 (at study Month 3 - primary phase)
Title
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
Description
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Time Frame
One month after dose 3 (at study Month 3 - primary phase)
Title
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
Description
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Time Frame
One month after dose 3 (at study Month 3 - primary phase)
Title
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Description
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Time Frame
One month after the booster vaccination (at study Month 1 - booster phase)
Title
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
Description
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Time Frame
One month after the booster vaccination (at study Month 1 - booster phase)
Title
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
Description
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Time Frame
One month after the booster vaccination (at study Month 1 - booster phase)
Secondary Outcome Measure Information:
Title
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
Description
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Time Frame
Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Title
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
Description
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Time Frame
Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Title
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Description
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Time Frame
Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Title
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Description
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 1 microgram per millilitre (µg/mL)
Time Frame
Prior to the booster vaccination (at study Month 0 - booster phase)
Title
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
Description
rSBA-MenC antibody titre cut-off value assessed was ≥1:8
Time Frame
Prior to the booster vaccination (at study Month 0 - booster phase)
Title
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
Description
rSBA-MenY antibody titre cut-off value assessed was ≥1:8
Time Frame
Prior to the booster vaccination (at study Month 0 - booster phase)
Title
rSBA-MenC Antibody Titres
Description
Titres are expressed as geometric mean titres (GMTs)
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
rSBA-MenY Antibody Titres
Description
Titres are expressed as geometric mean titres (GMTs)
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Description
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
Anti-PRP Antibody Concentrations
Description
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Description
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
Number of Subjects With Anti-polysaccharide Y (Anti-PSY) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Description
Anti-PSY antibody concentration cut-off value assessed was ≥0.30 µg/mL
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
Anti-PSC Antibody Concentrations
Description
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
Anti-PSY Antibody Concentrations
Description
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
Anti-tetanus Antibody Concentrations
Description
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN), Anti-pertussis Toxoid (Anti-PT) Antibody Concentrations
Description
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in Enzyme-Linked Immunosorbent Assay (ELISA) Units per millilitre.
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
Number of Seroprotected Subjects for Anti-tetanus Antibodies
Description
Seroprotection status is defined as anti-tetanus toxoid antibody concentration ≥ 0.1 International Units per millilitre (IU/mL)
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
Number of Subjects With Anti-FHA, Anti-PRN and Anti-PT Antibody Concentration Equal to or Above 5 Enzyme-Linked Immunosorbent Assay (ELISA) Units Per Millilitre (EL.U/mL)
Description
Anti-FHA, anti-PRN and anti-PT antibody concentration cut-off value assessed was ≥ 5 ELISA units per millilitre.
Time Frame
Prior to the first dose and one month after the third dose (at study Months 0 and 3 - primary phase)
Title
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Millilitre (µg/mL).
Description
Anti-PRP antibody concentration cut-off value assessed was equal to or above (≥) 0.15 microgram per millilitre (µg/mL)
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
Anti-PRP Antibody Concentrations
Description
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:128
Description
rSBA-MenC antibody titre cut-off value assessed was ≥1:128
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:128
Description
rSBA-MenY antibody titre cut-off value assessed was ≥1:128
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
rSBA-MenC Antibody Titres
Description
Titres are expressed as geometric mean titres (GMTs)
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
rSBA-MenY Antibody Titres
Description
Titres are expressed as geometric mean titres (GMTs)
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 0.30 Microgram Per Millilitre (µg/mL)
Description
Anti-PSC antibody concentration cut-off value assessed was ≥0.30 µg/mL
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Equal to or Above 2.0 Microgram Per Millilitre (µg/mL)
Description
Anti-PSC antibody concentration cut-off value assessed was ≥2.0 µg/mL
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
Anti-PSC Antibody Concentrations
Description
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
Anti-PSY Antibody Concentrations
Description
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in µg/mL.
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
Number of Subjects With Anti-tetanus Toxoid (Anti-T) Antibody Concentration Equal to or Above 0.1 International Units Per Millilitre (IU/mL).
Description
Anti-tetanus toxoid antibody concentration cut-off value assessed was ≥ 0.1 IU/mL
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
Anti-T Antibody Concentrations
Description
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in International Units per millilitre (IU/mL).
Time Frame
Prior to and one month post booster vaccination (at study Months 0 and 1 - booster phase)
Title
Anti-diphtheria Antibody Concentrations
Description
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in IU/mL.
Time Frame
One month after the third dose (at study Month 3 - primary phase)
Title
Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations
Description
Antibody concentrations are expressed as geometric mean concentrations (GMCs) in milli-International Units per millilitre (mIU/mL).
Time Frame
One month after the third dose (at study Month 3 - primary phase)
Title
Anti-poliovirus Types 1, 2, 3 Antibody Titres
Description
Titres are expressed as geometric mean titres (GMTs)
Time Frame
One month after the third dose (at study Month 3 - primary phase)
Title
Number of Seroprotected Subjects for Anti-diphtheria Antibodies
Description
Seroprotection status is defined as anti-diphtheria antibody concentrations ≥ 0.1 IU/mL
Time Frame
One month after the third dose (at study Month 3 - primary phase)
Title
Number of Seroprotected Subjects for Anti-hepatitis B Antibodies
Description
Seroprotection status is defined as anti-HBs antibody concentrations ≥ 10 mIU/mL
Time Frame
One month after the third dose (at study Month 3 - primary phase)
Title
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3 Antibodies
Description
Seroprotection status is defined as anti-polio 1, 2 and 3 antibody titres ≥ 1:8
Time Frame
One month after the third dose (at study Month 3 - primary phase)
Title
Number of Subjects With Vaccine Response to PT, FHA and PRN
Description
Vaccine response rates are defined as appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Time Frame
One month after the third dose (at study Month 3 - primary phase)
Title
Number of Subjects With Solicited Local Symptoms
Description
Solicited local symptoms assessed were pain, redness and swelling.
Time Frame
During the 8-day (Day 0-7) follow-up period (during the primary phase)
Title
Number of Subjects With Solicited General Symptoms
Description
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
Time Frame
During the 8-day (Day 0-7) follow-up period (during the primary phase)
Title
Number of Subjects With Unsolicited Adverse Events (AEs)
Description
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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
During the 31-day (Day 0-30) follow-up period (during the primary phase)
Title
Number of Subjects Reporting Serious Adverse Events (SAEs)
Description
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.
Time Frame
Over the full course of the primary phase (up to study Month 3 - primary phase)
Title
Number of Subjects With Solicited Local Symptoms
Description
Solicited local symptoms assessed were pain, redness and swelling.
Time Frame
During the 8-day (Day 0-7) follow-up period (during the booster phase)
Title
Number of Subjects With Solicited General Symptoms
Description
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (fever is defined as rectal temperature ≥ 38.0 degrees Celsius (°C)).
Time Frame
During the 8-day (Day 0-7) follow-up period (during the booster phase)
Title
Number of Subjects With Unsolicited Adverse Events (AEs)
Description
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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
During the 31-day (Day 0-30) follow-up period (during the booster phase)
Title
Number of Subjects Reporting Serious Adverse Events (SAEs)
Description
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.
Time Frame
Over the full course of the booster phase (up to study Month 1 - booster phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth. Exclusion Criteria: Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.
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
Asse
ZIP/Postal Code
1730
Country
Belgium
Facility Name
GSK Investigational Site
City
Drongen
ZIP/Postal Code
9031
Country
Belgium
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Maldegem
ZIP/Postal Code
9990
Country
Belgium
Facility Name
GSK Investigational Site
City
Merelbeke
ZIP/Postal Code
9820
Country
Belgium
Facility Name
GSK Investigational Site
City
Oudenaarde
ZIP/Postal Code
9700
Country
Belgium
Facility Name
GSK Investigational Site
City
Sint-Amandsberg
ZIP/Postal Code
9040
Country
Belgium
Facility Name
GSK Investigational Site
City
Cham
State/Province
Bayern
ZIP/Postal Code
93413
Country
Germany
Facility Name
GSK Investigational Site
City
Kaufering
State/Province
Bayern
ZIP/Postal Code
86916
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80939
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Facility Name
GSK Investigational Site
City
Noerdlingen
State/Province
Bayern
ZIP/Postal Code
86720
Country
Germany
Facility Name
GSK Investigational Site
City
Olching
State/Province
Bayern
ZIP/Postal Code
82140
Country
Germany
Facility Name
GSK Investigational Site
City
Niedernhausen
State/Province
Hessen
ZIP/Postal Code
65527
Country
Germany
Facility Name
GSK Investigational Site
City
Detmold
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32756
Country
Germany
Facility Name
GSK Investigational Site
City
Kirchlengern
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32278
Country
Germany
Facility Name
GSK Investigational Site
City
Loehne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32584
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04178
Country
Germany
Facility Name
GSK Investigational Site
City
Bredstedt
State/Province
Schleswig-Holstein
ZIP/Postal Code
25821
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24937
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24943
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10315
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13355
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14197
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22307
Country
Germany

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
20697200
Citation
Habermehl P, Leroux-Roels G, Sanger R, Machler G, Boutriau D. Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2,3,4 months schedule with a fourth dose at 12-18 months of age. Hum Vaccin. 2010 Aug;6(8):640-51. doi: 10.4161/hv.6.8.12154.
Results Reference
background
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
792014/003
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
792014/003
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
792014/003
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
792014/003
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
792014/003
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age

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