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

Condition(s) targeted: Meningococcal Infections; Haemophilus Infections

Intervention: Hib-MenCY-TT and Hib-MenC-TT vaccines (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: 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

Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Evaluate antibody responses to Hib and meningococcal serogroups C and Y in 3 different Hib-MenCY-TT formulations and one Hib-MenC-TT formulation as compared to licensed Hib and meningococcal serogroup C conjugate vaccines

Secondary outcome:

Evaluate the safety and reactogenicity of the 3 Hib-MenCY-TT formulations and the Hib-MenC-TT formulation

Evaluate antibody persistence, immune memory, and booster vaccine responses induced by Hib-MenCY-TT and Hib-MenC-TT

Detailed description: 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 Infanrix hexa® (a pediatric combination vaccine containing a Hib conjugate antigen licensed in Belgium and Germany) and Menjugate® (although use of Meningitec® was planned, Menjugate® was actually used due to vaccine availability. Both are MenC vaccines licensed in Belgium and Germany). All vaccines were administered at 2, 3, 4, and 12 to 18 months of age. The non-inferiority of immune responses and antibody persistence Hib and MenC in subjects receiving Hib-MenCY-TT vaccine was compared to the immune responses in recipients of the active control vaccines. In addition, the immunogenicity to MenY in recipients of Hib-MenCY-TT vaccine was summarized.

Minimum age: 6 Weeks. Maximum age: 12 Weeks. Gender(s): Both.

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.

Munich, Germany

Starting date: March 2003
Last updated: October 10, 2006