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Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.

This study has been terminated.
Information provided by:
GlaxoSmithKline Identifier:
First received: April 20, 2006
Last updated: September 29, 2011
Last verified: September 2011
A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.

Condition Intervention Phase
Haemophilus Influenzae Type b Disease
Hepatitis B
Prophylaxis for Diphtheria
Biological: Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Study to Assess Immunogenicity & Safety of GSK Bio Kft's DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft & vs Concomitant Administration of CSL's Triple Antigen & Hiberix (GSK Bio), to Infants 2,4,6 Mths of Age, After a Birth Dose of Hep B

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • GMC of anti-BPT Ab

Secondary Outcome Measures:
  • "anti-HBs, anti-diphtheria, anti-tetanus, anti-BPT & anti-PRP conc. & GMCs; vaccine response to BPT
  • Solicited & unsolicited symptoms, SAEs "

Estimated Enrollment: 288
Study Start Date: March 2006
Intervention Details:
    Biological: Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
    Other Names:
    • Diphtheria
    • tetanus
    • pertussis
    • hepatitis B
    • Hib vaccine
Detailed Description:

"The study will be carried out in a partially double blind manner (i.e. double blind with respect to DTPwGöd-HBV/Hib Kft and DTPwCSL-HBV/Hib Kft groups and open with respect to CSL's Triple Antigen & Hib group). Subjects will be randomly allocated to one of the three following groups to receive:

  • GSK Biologicals Kft's combined DTPwGöd-HBV/Hib Kft vaccine.
  • GSK Biologicals Kft's combined DTPwCSL-HBV/Hib Kft vaccine.
  • CSL's Triple Antigen + GSK Biologicals' Hib vaccines. There will be a specific follow-up of solicited local and general symptoms during 4 days after each vaccination and of unsolicited symptoms for 31 days after each vaccination. Serious adverse events reported during the study period will be recorded.

Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion criteria

  • Administration of one dose of hepatitis B vaccine at birth.
  • A healthy male or female between, and including, 6 and 12 weeks of age at the time of the first DTPw vaccination.

Exclusion criteria

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine hepatitis B vaccine for the Triple Antigen + Hib group.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life.
  • Previous vaccination against diphtheria, tetanus, pertussis and/or Hib/History of diphteria, tetanus, pertussis, hepatitis B and/ or hib disease.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00316680

Dominican Republic
GSK Investigational Site
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00316680     History of Changes
Other Study ID Numbers: 104489 
Study First Received: April 20, 2006
Last Updated: September 29, 2011
Health Authority: Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on September 27, 2016