Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Haemophilus Influenzae Type b

Diphtheria

Whole Cell Pertussis

Hepatitis B

Tetanus

Treatments

Biological: Hib-MenAC mixed with Tritanrix™-HepB

Study type

Interventional

Funder types

Industry

Identifiers

NCT00197275

104733

Details and patient eligibility

About

The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single injection.

Full description

The study is double blind. However the active control vaccine Tritanrix™-HepB/Hiberix™ will be administered in a single-blind manner. Blood samples will be collected for immunogenicity analyses. GSK Biologicals' OPV vaccine will be administered concomitantly with the study vaccines at 2, 4 and 6 months of age according to local country regulation. The study will last approximately 5 months per subject

Sex

All

Ages

56 to 83 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

healthy male or female, between, and including, 56 and 83 days of age.
Born after a gestation period between 36 and 42 weeks
Birth dose of hepatitis B vaccine within the first 72 hours of life

Exclusion criteria

planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period.
Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
History of OR previous vaccination against OR known exposure since birth to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal 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