CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 617 enrolled
Drug / intervention
Tritanrix-HepB/Hib-MenAC +3 morebiological
Likely dose
Tritanrix-HepB/Hib-MenAC (4th dose) at 15-24 months; Mencevax ACWY (1 dose) at 24-30 monthsAI-extracted
Key inclusion· 3
  • ✓Healthy male or female infant
  • ✓Age 15-24 months at enrollment
  • ✓Prior participation in primary vaccination study DTPW-HBV=HIB-MENAC-TT-003
Key exclusion· 6
  • ✕Any unplanned booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Hib, or meningococcal serogroups A or C after primary study conclusion
  • ✕History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib, or meningococcal serogroup A or C disease
  • ✕Any confirmed or suspected immunosuppressive or immunodeficient condition
  • ✕Family history of congenital or hereditary immunodeficiency

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

Search/NCT00136604
NCT00136604Phase 3Completed
CompareCT.gov

Assess Immunogenicity, Safety & Reactogenicity of a 4th Dose of GSK Biologicals' Tritanrix-HepB/Hib-MenAC at 15-24 m & of a Dose of Mencevax ACWY at 24-30 m in Subjects Primed With 3 Doses of Tritanrix-HepB/Hib-MenAC

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

In Brief

A Phase 3 clinical trial evaluating Tritanrix-HepB/Hib-MenAC, Mencevax ACWY, and 2 other interventions for Whole Cell Pertussis and 5 related conditions. Completed, enrolled 617 participants across 3 sites.

Detailed Summary

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.

Study Details

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

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2005
Enrollment StartJan 22, 2006
Primary CompletionApr 23, 2006
TodayJul 2, 2026
Enrollment to primary: 3 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

Mencevax ACWYbiological

GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine

Tritanrix-HepB/Hiberixbiological

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

Meningitecbiological

Wyeth's MenC CRM197 conjugated vaccine, Meningitec