Status:
COMPLETED
Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib, Compared to DTPa-HBV-IPV and Hib Administered Separately
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Diphtheria
Eligibility:
All Genders
12-16 years
Phase:
PHASE3
Brief Summary
This study will assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' (formerly SB Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared with separate administration of...
Eligibility Criteria
Inclusion
- A male or female 3 months 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 after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure.
Exclusion
- The following criteria should be checked at the time of study entry. If any apply at the time of study entry, the subject must not be included in the study:
- Use of any investigational or non-registered 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.
- Administration of chronic immunosuppressants or other immune-modifying drugs within three months before vaccination.
- Administration of a vaccine not foreseen by the study within 30 days before each dose of the study vaccines and ending 30 days after.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
- History of /or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease or infection.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B.
- Major congenital defects or serious chronic illness.
- History of seizures or of any neurological disease at study entry.
- Administration of immunoglobulins and/or any blood products since birth, or planned administration during the study period.
- Acute disease at time of enrolment
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2000
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT01457508
Start Date
January 1 1999
End Date
March 1 2000
Last Update
June 16 2017
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