CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 745 enrolled
Drug / intervention
Tritanrix™-HepB/Hiberix™ Kft. +4 morebiological
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Male or female infant aged 10–11 months (for PRP followed by DTPw-HBV arm) or 15–18 months (for DTPw-HBV/Hib or DTPw-HBV+Hib arms)
  • ✓Previously completed three-dose primary vaccination course with DTPw-HBV/Hib vaccine
  • ✓Investigator believes parent/guardian can and will comply with protocol requirements
  • ✓Free of obvious health problems by medical history and clinical examination
Key exclusion· 3
  • ✕Use of any investigational or non-registered product (other than study vaccine) within 30 days before vaccine administration or planned use during study
  • ✕Chronic immunosuppressant or immune-modifying drug use within 6 months prior to vaccine administration
  • ✕Planned or concurrent non-protocol vaccines from 30 days before to 30 days after study vaccine (except oral polio vaccine)

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

Search/NCT00169442
NCT00169442Phase 3Completed
CompareCT.gov

Immune Memory of GSK's DTPw-HBV/Hib Vaccine by Giving Plain PRP Polysaccharide at 10 Mths. Immuno & Reacto of a Booster Dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 Mths in Infants Previously Primed With DTPw-HBV/Hib

GlaxoSmithKline·interventional·Posted Sep 15, 2005·Updated Jun 6, 2018

In Brief

A Phase 3 clinical trial evaluating Tritanrix™-HepB/Hiberix™ Kft., Tritanrix™-HepB/Hiberix™, and 3 other interventions for Whole Cell Pertussis and 4 related conditions. Completed, enrolled 745 participants across 3 sites.

Detailed Summary

To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.

Study Details

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

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartFeb 10, 2005
Primary CompletionMar 1, 2006
Study CompletionMar 10, 2006
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.8 years ago

Interventions

Tritanrix™-HepB/Hiberix™ Kft.biological

GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.

Tritanrix™-HepB/Hiberix™biological

GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine

Hiberix™biological

GSK Biologicals' Haemophilus influenzae type b vaccine

Polyribosil-Ribitol-Phosphate (PRP) vaccinebiological

plain PRP polysaccharide vaccine

Tritanrix™-HepB Kftbiological

GSK Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.