Haemophilus Influenzae Type b, Neisseria Meningitidis
Conditions
Brief summary
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.
Detailed description
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).
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Poland, United Kingdom
Outcome results
None listed