Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00317187
NCT00317187CompletedPhase 3

Partially Blinded Study to Assess Reactogenicity & Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ in Healthy Infants After a Hepatitis B Birth Dose

GlaxoSmithKline2 sites in 1 country500 target enrollmentStarted: June 8, 2004Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
500
Locations
2
Primary Endpoint
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to compare the reactogenicity & safety of Tritanrix™-HepB/Hib-MenAC vaccine to the international standard of care, Tritanrix™-HepB/Hiberix™.

Detailed Description

Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:

  • One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups)
  • GSK Biologicals' Tritanrix™-HepB/Hiberix™

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention

Eligibility Criteria

Ages
56 Days to 83 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1

Time Frame: Days 0-3 post dose 1

Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3

Time Frame: Days 0-3 post dose 3

Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2

Time Frame: Days 0-3 post dose 2

Secondary Outcomes

  • Occurrence of serious adverse events during the entire study period(Day 0 up to Month 5)
  • Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose(Day 0-30 after each dose)
  • Occurrence of solicited symptoms other than fever >38.5°C (axillary) during the 4-day follow-up period after each dose(Days 0-3 after each dose)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Completed
Phase 3
Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.Whole Cell PertussisHaemophilus Influenzae Type bHepatitis BDiphtheriaTetanus
NCT00317135GlaxoSmithKline500
Completed
Phase 3
Assess if Immune Response of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC Given Without or With Hepatitis B Vaccine at Birth is at Least as Good as Tritanrix™-HepB/Hiberix™ Without Hepatitis B Vaccine at Birth, When Given to Healthy InfantsHaemophilus Influenzae Type bWhole Cell PertussisHepatitis BDiphtheriaTetanus
NCT00290303GlaxoSmithKline996
Completed
Phase 1
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Staphylococcal Investigational Vaccine in Healthy AdultsInfections, Staphylococcal
NCT01160172GlaxoSmithKline88
Completed
Phase 3
Study Comparing Immunogenicity, Reactogenicity and Safety of GSK Bios' HBV-MPL Vaccine With That of Engerix™-B in AdultsHepatitis B
NCT00696891GlaxoSmithKline380
Terminated
Phase 4
Study Comparing DTP-HB-Hib by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In InfantsImmune Response to DTP-HB-Hib Vaccine
NCT02409095Serum Institute of India Pvt. Ltd.211
Safety Study of a Vaccine Against... | Clinical Trial