Status:
COMPLETED
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
8-16 years
Phase:
PHASE2
Brief Summary
The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tet...
Detailed Description
Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT vaccine (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations double-blind) + Infanrix pe...
Eligibility Criteria
Inclusion
- Healthy male or female infants, 8 to 16 weeks of age at the time of the first vaccination.
Exclusion
- Previous vaccination against OR history of OR exposure since birth to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
- Planned administration/administration of a vaccine not foreseen in the study since birth.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of any neurologic disorders or seizures, allergic disease or reactions likely to be exacerbated by any component of the vaccine
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2003
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00135486
Start Date
March 1 2002
End Date
January 1 2003
Last Update
September 16 2016
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