ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Response to GSK Biologicals’ Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00136604
  Purpose

The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix™-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax™ ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Hepatitis B
Haemophilus Infections
Meningococcal Infections
Biological: Diphtheria-tetanus-pertussis-hep B/Hib-meningococcal A&C
Phase III

MedlinePlus related topics:   Diphtheria    Hepatitis    Hepatitis B    Tetanus    Whooping Cough   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Assess Immunogenicity, Safety & Reactogenicity of a 4th Dose of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC at 15-24 m & of a Dose of Mencevax™ ACWY at 24-30 m in Subjects Primed With 3 Doses of Tritanrix™-HepB/Hib-MenAC

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 1M post 4th dose of study vaccine & applicable control: SBA-MenC/A≥128, anti-PRP≥1. 1M post Mencevax booster in subjects primed with MenAC conjugate: SBA-MenC/A≥128.

Secondary Outcome Measures:
  • Pre and 1M post each vacc dose: antibody conc or titer, seroprot, seropos and/or vacc response to all antigens administered. Loc/gen symp: D 0-3, unsol symp: D 0-30 post each vac. SAE for entire study.

Estimated Enrollment:   1000

Detailed Description:

This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax™ ACWY phase at 24-30 months a dose of Mencevax™ ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax™ ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered.

  Eligibility
Ages Eligible for Study:   427 Days to 730 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion criteria:

  • Healthy male or female between and including 15 and 24 months of age
  • Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)

Exclusion criteria:

  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).
  • History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136604

Locations
Thailand
GSK Clinical Trials Call Center    
      Bangkok, Thailand

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     Clinical Trials     GlaxoSmithKline    
  More Information

Primary Study  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   104727 (Booster - 15-24 mths), 104730 (Booster - 24-30 mths)
First Received:   August 26, 2005
Last Updated:   June 12, 2007
ClinicalTrials.gov Identifier:   NCT00136604
Health Authority:   Thailand: Ethical Committee

Keywords provided by GlaxoSmithKline:
Prophylaxis diphtheria  
Hib & meningococcal serogroup A & C disease  

Study placed in the following topic categories:
Haemophilus Infections
Bacterial Infections
Liver Diseases
Hepatitis, Viral, Human
Whooping Cough
Cough
Diphtheria
Tetanus
Whooping cough
Meningococcal infection
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:
Bordetella Infections
Pasteurellaceae Infections
Communicable Diseases
Corynebacterium Infections
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on August 28, 2008




Links to all studies - primarily for crawlers