CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 798 enrolled
Drug / intervention
Tritanrix-HepB/Hib-MenAC +2 morebiological
Likely dose
Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix booster at 15–24 months; Mencevax ACWY dose at 24–30 months (specific dose volumes/amounts not specified in available text)AI-extracted
Key inclusion· 4
  • ✓Healthy male or female child
  • ✓Age 15–18 months (Philippines) or 15–24 months (Thailand) at time of vaccination
  • ✓Previously received 3-dose primary vaccination in prior studies DTPwHB/HibMenAC-TT-004 or DTPW-HBV=HIB-MENAC-TT-013
  • ✓Written informed consent from parent or guardian
Key exclusion· 4
  • ✕Use of any investigational or non-registered product within 30 days before vaccination
  • ✕Chronic immunosuppressants or immune-modifying drugs (>14 days) within 6 months prior to vaccination
  • ✕Planned vaccine administration not in study protocol within 30 days of vaccination (except oral poliovirus vaccine)
  • ✕Prior booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Hib, or meningococcal A/C after the primary vaccination study conclusion visit

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00228917
NCT00228917Phase 3Completed
CompareCT.gov

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)

GlaxoSmithKline·interventional·Posted Sep 29, 2005·Updated Feb 20, 2020

In Brief

A Phase 3 clinical trial evaluating Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and 1 other intervention for Whole Cell Pertussis and 5 related conditions. Completed, enrolled 798 participants across 2 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWhole Cell Pertussis, Tetanus, Hepatitis B, Diphtheria, Haemophilus Influenzae Type b, Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin
CountriesPhilippines, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 29, 2005
Enrollment StartJun 16, 2005
Primary CompletionJan 20, 2006
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 20.8 years ago

Interventions

Tritanrix-HepB/Hib-MenACbiological

Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine

Tritanrix-HepB/Hiberixbiological

Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine

Mencevax-ACWYbiological

Meningococcal Serogroups A, C, W-135 and Y Vaccine