NCT00228917

Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children

Assess Reactogenicity & Safety of a Booster of Either Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix Given (Single-blind) at 15-18 (Philippines)/15-24 Mths (Thailand) & a Dose of Mencevax ACWY at 24-30 Mths (Open Label)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 798 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 427 Days – 577 Days
• Healthy volunteers: Accepted

Summary

This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC. No blood samples will be taken in this safety study.

Detailed description

Subjects previously primed with Tritanrix-HepB/Hib-MenAC will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m), respectively, without or with Mencevax ACWY vaccine at 24 to 30 months of age. Subjects previously primed with Tritanrix-HepB/Hiberix will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m) with Mencevax ACWY vaccine at 24 to 30 months of age.

Conditions

• Whole Cell Pertussis
• Tetanus
• Hepatitis B
• Diphtheria
• Haemophilus Influenzae Type b
• Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin

Interventions

Type	Name	Description
BIOLOGICAL	Tritanrix-HepB/Hib-MenAC	Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
BIOLOGICAL	Tritanrix-HepB/Hiberix	Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
BIOLOGICAL	Mencevax-ACWY	Meningococcal Serogroups A, C, W-135 and Y Vaccine

Timeline

• Start date: 2005-06-16
• Primary completion: 2006-01-20
• Completion: 2006-01-20
• First posted: 2005-09-29
• Last updated: 2020-02-20
• Results posted: 2017-03-29

Locations

2 sites across 2 countries: Philippines, Thailand