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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00228917
First received: September 27, 2005
Last updated: September 20, 2016
Last verified: September 2016
  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
Whole Cell Pertussis
Tetanus
Hepatitis B
Diphtheria
Haemophilus Influenzae Type b
Biological: DTPw-HBV/Hib-MenAC-TT vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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:


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.

Enrollment: 798
Study Start Date: June 2005
Study Completion Date: September 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103812 are summarised with study 104727 on the GSK Clinical Study Register.
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00228917     History of Changes
Other Study ID Numbers: 103812  104171 
Study First Received: September 27, 2005
Last Updated: September 20, 2016
Health Authority: Thailand: Ministry of Public Health
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Hib & Neisseria meningitidis serogroups A & C diseases

Additional relevant MeSH terms:
Hepatitis B
Diphtheria
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016