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.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316680
First received: April 20, 2006
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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
Pertussis
Tetanus
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.

"

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT00316680

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov 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:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Clostridium Infections

ClinicalTrials.gov processed this record on July 31, 2014