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

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.

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Key information

Conditions

Tetanus Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Bordetella Infections Clostridium Infections Communicable Diseases Corynebacterium Infections DNA Virus Infections Digestive System Diseases Diphtheria Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Haemophilus Infections Haemophilus Influenzae Type b Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Pasteurellaceae Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Whole Cell Pertussis Whooping Cough

Age range

56 day–83 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bangkok, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hib-MenAC mixed with Tritanrix™-HepB

Biological

Primary outcomes

Immune response 1 month post dose 3 (SBA-MenA/C titers ≥ 1:8, anti-PRP ≥ 0.15 µg/ml, -diphtheria ≥ 0.1 IU/ml (ELISA) OR ≥ 0.016 IU/ml (Vero-cell test), -tetanus ≥ 0.1 IU/ml, -HB concentration ≥ 10 mIU/ml, vaccine response to Bordetella pertus

Secondary outcomes

Antibody conc or titer, seroprot, seropos and/or vacc response to all antigens administered (Prior to dose 1, 2 m after dose 2 & 1m after dose 3). After each dose: Solicited (d 0-3, local/general), unsolicited (d 0-30) symptoms. During whole study: SAEs

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Demonstrate Lot-to-lot Consistency of Final Production Method of GSK Biologicals' Hib-MenAC Vaccine Mixed Extemporaneously With Tritanrix™-HepB & Demonstrate Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Healthy Infants at 2, 4 and 6 Months

Important dates

Study start: 2006
Study completion: 2006
First posted: Sep 20, 2005
Registry last updated: Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed