Safety Study of a Vaccine Against Meningitis in Infants ( 2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.

Phase 3

Completed

• Conditions: Haemophilus Influenzae Type b; Diphtheria; Whole Cell Pertussis; Hepatitis B; Tetanus
• Interventions: Biological: Tritanrix-HepB/Meningitec conjugate vaccine; Biological: Tritanrix/Hiberix vaccine

• Registration Number: NCT00317135
• Lead Sponsor: GlaxoSmithKline

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™

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-12-11
• Primary Completion: 2004-10-23
• Study Completion: 2004-10-23
• Study First Submitted: 2006-02-15
• Study First Submitted QC: 2006-04-20
• Study First Posted: 2006-04-24
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hib-MenAC Lot 1 Group	Tritanrix-HepB/Meningitec conjugate vaccine	Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
Hib-MenAC Lot 2 Group	Tritanrix-HepB/Meningitec conjugate vaccine	Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.
Hiberix Group	Tritanrix/Hiberix vaccine	Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh.
Hib-MenAC Lot 3 Group	Tritanrix-HepB/Meningitec conjugate vaccine	Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh.

Primary Outcome Measures

Name	Time	Method
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 1	Days 0-3 post dose 1
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 3	Days 0-3 post dose 3
Occurrence of fever > 38.5°C(axillary) during the 4-day follow-up period after dose 2	Days 0-3 post dose 2

Secondary Outcome Measures

Name	Time	Method
Occurrence of unsolicited symptoms during the 31-day follow-up period after each dose	Day 0-30 after each dose
Occurrence of serious adverse events during the entire study period	Day 0 up to Month 5
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇭 Muntinlupa, Philippines