Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.

This study has been terminated.
Information provided by:
GlaxoSmithKline Identifier:
First received: October 15, 2007
Last updated: September 29, 2011
Last verified: September 2011
To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.

Condition Intervention Phase
Hepatitis A
Biological: INFANRIX
Biological: BOOSTRIX
Biological: HAVRIX
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency & Reactogenicity of DTPa - INFANRIX & dTpa - BOOSTRIX Vaccines Admnd to Healthy Children Previously Primed With 3 Doses of DTPa Vaccine Compared to Placebo (HAVRIX®JUNIOR).

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
  • Occurrence of local injection site reactions (1M after vacc).

Secondary Outcome Measures:
  • Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
  • Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
  • SAEs (full study).

Enrollment: 720
Study Start Date: May 2003
Intervention Details:
    Biological: INFANRIX Biological: BOOSTRIX Biological: HAVRIX
    Other Names:

Ages Eligible for Study:   18 Months to 20 Months   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male or female children between and including 18 -20 months of age at the time of the vaccination.
  • Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
  • Written informed consent obtained before study entry from the parents or guardians of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
  • Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.
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Please refer to this study by its identifier: NCT00544271

Australia, Victoria
GSK Investigational Site
Carlton, Victoria, Australia, 3053
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00544271     History of Changes
Other Study ID Numbers: 263855/035 
Study First Received: October 15, 2007
Last Updated: September 29, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Hepatitis A
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on August 24, 2016