Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Haemophilus Influenzae Type b

Neisseria Meningitidis

Treatments

Biological: Haemophilus influenzae type b- and meningococcal (vaccine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00258700

104056 (Other Identifier)

103974 (primary study)

Details and patient eligibility

About

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.

Full 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).

Enrollment

478 patients

Sex

All

Ages

6 to 12 weeks old

Volunteers

Accepts Healthy Volunteers

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