CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,590 enrolled
Drug / intervention
GSK Biologicals' combined DTPa-IPV/Hib vaccinebiological
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/NCT00325156
NCT00325156Phase 4Completed
CompareCT.gov

An Open, Multicentric, Post-marketing Surveillance Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 and 18 Months of Age, in Healthy Infants.

GlaxoSmithKline·interventional·Posted May 12, 2006·Updated Jan 2, 2020

In Brief

A Phase 4 clinical trial evaluating GSK Biologicals' combined DTPa-IPV/Hib vaccine for Diphtheria and 5 related conditions. Completed, enrolled 2,590 participants across 1 site.

Detailed Summary

To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The 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--
ConditionsDiphtheria, Tetanus, Poliomyelitis, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria-Tetanus-aPertussis-Poliomyelitis Vaccines
CountriesSingapore
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 12, 2006
Enrollment StartNov 2, 2004
Primary CompletionAug 23, 2007
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.1 years ago

Interventions

GSK Biologicals' combined DTPa-IPV/Hib vaccinebiological

4 intramuscular injections