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Immunogenicity, Safety & Reactogenicity of GSK Vaccine Tritanrix™-HepB/Hib2.5 Compared to GSK Vaccine Tritanrix™-HepB/Hiberix™

NCT01061541 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2016-09-09

No results posted yet for this study

Summary

In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5). The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive Tritanrix™-HepB/Hiberix™.

Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects 50% were randomised to participate in the PRP challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).

Conditions

  • Haemophilus Influenzae Type b

Interventions

BIOLOGICAL

Tritanrix™-HepB low thio /

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

BIOLOGICAL

Hib 2.5

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

BIOLOGICAL

Tritanrix™-HepB

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

BIOLOGICAL

Hiberix™

One dose as intramuscular injection at 6, 10 and 14 weeks of age.

BIOLOGICAL

Unconjugated Hib vaccine (plain PRP)

One dose as intramuscular injection at 10 months of age

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2004-01-31
Completion
2004-08-31

Countries

  • Philippines

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01061541 on ClinicalTrials.gov