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Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children

Assess Reactogenicity & Safety of a Booster of Either Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix Given (Single-blind) at 15-18 (Philippines)/15-24 Mths (Thailand) & a Dose of Mencevax ACWY at 24-30 Mths (Open Label)

NCT00228917•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC. No blood samples will be taken in this safety study.

Detailed Description

Subjects previously primed with Tritanrix-HepB/Hib-MenAC will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m), respectively, without or with Mencevax ACWY vaccine at 24 to 30 months of age. Subjects previously primed with Tritanrix-HepB/Hiberix will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m) with Mencevax ACWY vaccine at 24 to 30 months of age.

Eligibility

Age

1 - 1 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).

Exclusion Criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
•Chronic administration (\> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
•Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral poliovirus vaccine can be given concomitantly.
•Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study.

Locations (2)

GSK Investigational Site

City of Muntinlupa, Philippines

GSK Investigational Site

Bangkok, Thailand

Key Dates

Start Date

June 16, 2005

Primary Completion Date

January 20, 2006

Completion Date

January 20, 2006

Last Updated

February 20, 2020

Enrollment

798

ACTUAL participants

Conditions

Whole Cell PertussisTetanusHepatitis BDiphtheriaHaemophilus Influenzae Type bDiphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin

Interventions

Tritanrix-HepB/Hib-MenAC

BIOLOGICAL

Tritanrix-HepB/Hiberix

BIOLOGICAL

Mencevax-ACWY

BIOLOGICAL

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Hepatitis B Virus Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety Study of Tritanrix-HepB/Hib-MenAC, Tritanrix-HepB/Hiberix, and Mencevax ACWY Vaccines in Children

Inclusion Criteria

Exclusion Criteria

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