Status:
TERMINATED
Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haemophilus Influenzae Type b
Diphtheria
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
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 Haemoph...
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 \&...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00316680
Start Date
March 1 2006
End Date
November 1 2006
Last Update
October 7 2016
Active Locations (1)
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1
GSK Investigational Site
Santo Domingo, Dominican Republic