Assess the Immune Response Following Primary Vaccination With GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ Given at 6,10 & 14 Wks of Age to Infants Who Received Hepatitis B Vaccine at Birth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-07-31

Brief Summary

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This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) \& hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.

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Detailed Description

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Randomized study with two groups to receive one of the following vaccination regimens:

* GSK Biologicals' Tritanrix™-HepB/Hib-MenAC
* GSK Biologicals' Tritanrix™-HepB/Hiberix™

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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DTPw-HBV/Hib-MenAC conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV \& HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.

Exclusion Criteria

* Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
* A family history of congenital or hereditary immunodeficiency.
* Major congenital defects or serious illness.
* Any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* A birth dose of hepatitis B vaccine given outside the frame of this study.

Minimum Eligible Age

4 Days

Maximum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Brits, , South Africa

Site Status

GSK Investigational Site

Brits, , South Africa

Site Status

GSK Investigational Site

Centurion, , South Africa

Site Status

GSK Investigational Site

Ga-Rankuwa, , South Africa

Site Status

Countries

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South Africa

Study Documents

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