Status:
COMPLETED
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Diphtheria
Eligibility:
All Genders
12-16 years
Phase:
PHASE2
Brief Summary
This study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administra...
Eligibility Criteria
Inclusion
- A male or female between 12 and 16 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 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
- 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 immune-modifying drugs during the study period.
- Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases.
- History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reaction 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.
- Progressive neurological disorders.
- Administration of immunoglobulins and/or any blood products since birth and during the study period.
- Acute febrile illness at the time of planned vaccination.
Key Trial Info
Start Date :
September 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 1999
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT01457495
Start Date
September 1 1998
End Date
September 1 1999
Last Update
June 16 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.