Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.

Phase 3

Terminated

• Conditions: Tetanus; Diphtheria; Hepatitis B; Haemophilus Influenzae Type b; Whole Cell Pertussis

• Registration Number: NCT00316680
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.

Detailed Description

"The study will be carried out in a partially double blind manner (i.e. double blind with respect to DTPwGöd-HBV/Hib Kft and DTPwCSL-HBV/Hib Kft groups and open with respect to CSL's Triple Antigen \& Hib group). Subjects will be randomly allocated to one of the three following groups to receive:

* GSK Biologicals Kft's combined DTPwGöd-HBV/Hib Kft vaccine.

* GSK Biologicals Kft's combined DTPwCSL-HBV/Hib Kft vaccine.

* CSL's Triple Antigen + GSK Biologicals' Hib vaccines. There will be a specific follow-up of solicited local and general symptoms during 4 days after each vaccination and of unsolicited symptoms for 31 days after each vaccination. Serious adverse events reported during the study period will be recorded.

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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-20
• Study First Submitted QC: 2006-04-20
• Study First Posted: 2006-04-21
• Study Completion: 2006-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
GMC of anti-BPT Ab

Secondary Outcome Measures

Name	Time	Method
anti-HBs, anti-diphtheria, anti-tetanus, anti-BPT & anti-PRP conc. & GMCs; vaccine response to BPT
Solicited & unsolicited symptoms, SAEs "

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇴 Santo Domingo, Dominican Republic