Status:
COMPLETED
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diphtheria
Poliomyelitis
Eligibility:
All Genders
6-8 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitan...
Eligibility Criteria
Inclusion
- A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
Exclusion
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- Major congenital defects
- Serious chronic illness
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease at the time of enrollment.
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2001
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00879827
Start Date
September 1 2000
End Date
May 1 2001
Last Update
September 7 2016
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