Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine
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The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15 months of age.
Condition or disease
Haemophilus Influenzae Type bNeisseria Meningitidis
Biological: Haemophilus influenzae type b- and meningococcal (vaccine)
This multicenter study is open with respect to the treatment allocation, but double-blind with respect to the Hib-MenC-TT lots (3 lots). The study will be conducted in two stages. Primary vaccination phase: 3 doses Hib-MenC-TT with Infanrix™-IPV or for the control group a licensed Men-C vaccine with Pediacel™ at 2, 3, 4 months of age; Booster/persistence phase: 1 dose Hib-MenC with Priorix™. 4 blood samples of 3.5ml (5ml for the UK subset) are collected (Study Months 0 & 3, prior to & 42 days after the booster).
Demonstrate Non-inferiority of Men-C Immune Response of Hib-MenC With Infanrix™-IPV Versus a Licensed Men-C Vaccine With Pediacel™ When Given at 2, 3, 4 Months and the Immunogenicity of Hib-MenC When Given as a Booster Dose at 12-15 Months
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
1 m after the 3rd dose of primary vaccination: SBA-MenC titre ≥ 1:8 (seroprotection status), anti-PRP concentration ≥ 0.15 µg/ml. 42 d after the booster vaccination: SBA-MenC titre ≥ 1:128, anti-PRP concentration ≥ 1 μg/ml
Secondary Outcome Measures :
Antibody levels to all vaccine antigens:1 m post dose 3, prior to & 42 d post booster. After each dose: Solicited (d 0-3, local & general), unsolicited (d 0-30) & MMR specific (d 0-42) symptoms. SAEs (whole study).
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Ages Eligible for Study:
6 Weeks to 12 Weeks (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy male or female, between, and including, 6 and 12 weeks of age.
Born after a gestation period between 36 and 42 weeks
Vaccination with hepatitis B at birth and at 6 to 12 weeks (concomitantly with the first study vaccine), accepted although not mandatory
Planned administration/ administration of a vaccine not foreseen by the study protocol since birth, with the exception of Bacille Calmette Guerin (BCG) and hepatitis B vaccines.
History of H. influenzae type b and /or meningococcal serogroup C disease.
Previous vaccination against meningococcal serogroup C disease, diphtheria, tetanus, pertussis, polio or Hib disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
A family history of congenital or hereditary immunodeficiency
History of any neurologic disorders or seizures
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine