CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 702 enrolled
Drug / intervention
DTPa-HBV-IPV/Hib +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00325143
NCT00325143Phase 3Completed
CompareCT.gov

Assess Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Admnd at 3 & 4 Mths & DTPa-HBV-IPV/Hib Vaccine Admnd at 5 Mths, Followed by DTPa-IPV/Hib Vaccine at 18 Mths in Infants Who Received hepatitisB Vaccine at Birth & at One Month of Age

GlaxoSmithKline·interventional·Posted May 12, 2006·Updated Jun 6, 2018

In Brief

A Phase 3 clinical trial evaluating DTPa-HBV-IPV/Hib and DTPa-IPV/Hib vaccine for Haemophilus Influenzae Type b and 4 related conditions. Completed, enrolled 702 participants across 3 sites.

Detailed Summary

To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHaemophilus Influenzae Type b, Diphtheria, Tetanus, Poliomyelitis, Acellular Pertussis
CountriesSingapore
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 12, 2006
Enrollment StartDec 1, 2003
Primary CompletionFeb 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 20.1 years ago

Interventions

DTPa-HBV-IPV/Hibbiological

1 intramuscular injection (3rd study vaccine dose)

DTPa-IPV/Hib vaccinebiological

3 intramuscular injections (1st, 2nd and 4th vaccine dose)