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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00228917

Purpose

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.

Condition	Intervention	Phase
Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Infection Meningococcal Infection	Biological: DTPw-HBV/Hib-MenAC-TT vaccine	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Parallel Assignment, Safety Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Diphtheria Fever Hepatitis Hepatitis B Tetanus Whooping Cough

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

D0-3: Fever >38.5°C (axillary).

Secondary Outcome Measures:

D0-3: Solicited local & general symptoms (including fever other than >38.5°C). D0-30: unsol. symptoms. SAEs -full study period.

Estimated Enrollment:

999

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

Ages Eligible for Study:	427 Days to 577 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228917

Locations

Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	103812, 104171
Study First Received:	September 27, 2005
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00228917 History of Changes
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by GlaxoSmithKline:

Hib & Neisseria meningitidis serogroups A & C diseases

Study placed in the following topic categories:

Haemophilus Infections
Bacterial Infections
Liver Diseases
Hepatitis, Viral, Human
Whooping Cough
Cough
Neisseria Meningitidis
Meningococcal Infection
Diphtheria
Tetanus
Gram-Negative Bacterial Infections

Virus Diseases
Hepatitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Meningococcal Infections
Hepatitis B
DNA Virus Infections
Neisseriaceae Infections

Additional relevant MeSH terms:

Haemophilus Infections
Bacterial Infections
Pasteurellaceae Infections
Communicable Diseases
Liver Diseases
Hepatitis, Viral, Human
Whooping Cough
Diphtheria
Infection
Hepadnaviridae Infections
Actinomycetales Infections
Gram-Negative Bacterial Infections

Virus Diseases
Hepatitis
Bordetella Infections
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Corynebacterium Infections
Meningococcal Infections
Hepatitis B
DNA Virus Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on September 03, 2009