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
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
2 other identifiers
interventional
388
2 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2003
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2003
CompletedFirst Submitted
Initial submission to the registry
August 10, 2005
CompletedFirst Posted
Study publicly available on registry
August 11, 2005
CompletedResults Posted
Study results publicly available
July 23, 2012
CompletedAugust 27, 2018
October 1, 2016
9 months
August 10, 2005
June 15, 2012
July 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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)
One month after dose 3 (at study Month 3 - primary phase)
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
One month after dose 3 (at study Month 3 - primary phase)
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
One month after dose 3 (at study Month 3 - primary phase)
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)
One month after the booster vaccination (at study Month 1 - booster phase)
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
One month after the booster vaccination (at study Month 1 - booster phase)
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
One month after the booster vaccination (at study Month 1 - booster phase)
Secondary Outcomes (45)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Number of Subjects With Meningococcal Serogroup Y Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenY) Titre Equal to or Above 1:8
Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Before the administration of the first dose (at pre-vaccination = study Month 0 - primary phase)
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL).
Prior to the booster vaccination (at study Month 0 - booster phase)
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titre Equal to or Above 1:8
Prior to the booster vaccination (at study Month 0 - booster phase)
- +40 more secondary outcomes
Study Arms (5)
Menhibrix F1/Infanrix-penta Group
EXPERIMENTALSubjects 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.
Menhibrix F2/Infanrix-penta Group
EXPERIMENTALSubjects 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.
Menhibrix F3/Infanrix-penta Group
EXPERIMENTALSubjects 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.
Menitorix/Infanrix-penta Group
EXPERIMENTALSubjects 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.
Menjugate/Infanrix-hexa Group
ACTIVE COMPARATORSubjects 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.
Interventions
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (26)
GSK Investigational Site
Asse, 1730, Belgium
GSK Investigational Site
Drongen, 9031, Belgium
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Maldegem, 9990, Belgium
GSK Investigational Site
Merelbeke, 9820, Belgium
GSK Investigational Site
Oudenaarde, 9700, Belgium
GSK Investigational Site
Sint-Amandsberg, 9040, Belgium
GSK Investigational Site
Cham, Bavaria, 93413, Germany
GSK Investigational Site
Kaufering, Bavaria, 86916, Germany
GSK Investigational Site
Munich, Bavaria, 80939, Germany
GSK Investigational Site
Munich, Bavaria, 81675, Germany
GSK Investigational Site
Nördlingen, Bavaria, 86720, Germany
GSK Investigational Site
Olching, Bavaria, 82140, Germany
GSK Investigational Site
Niedernhausen, Hesse, 65527, Germany
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756, Germany
GSK Investigational Site
Kirchlengern, North Rhine-Westphalia, 32278, Germany
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584, Germany
GSK Investigational Site
Leipzig, Saxony, 04178, Germany
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24943, Germany
GSK Investigational Site
Berlin, 10315, Germany
GSK Investigational Site
Berlin, 12627, Germany
GSK Investigational Site
Berlin, 13355, Germany
GSK Investigational Site
Berlin, 14197, Germany
GSK Investigational Site
Hamburg, 22307, Germany
Related Publications (2)
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.
PMID: 21806393BACKGROUNDHabermehl 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.
PMID: 20697200BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2005
First Posted
August 11, 2005
Study Start
March 1, 2003
Primary Completion
December 1, 2003
Study Completion
December 16, 2003
Last Updated
August 27, 2018
Results First Posted
July 23, 2012
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.