Trial intelligence / Profile preview

Hib-MenCY-TT Primary & Booster Study

NCT00134719Phase 2Completed

Sponsor
GSK
Start
Apr 2005
Primary completion
Jul 2006
Modality
Vaccines & Immunotherapeutics
Countries
1
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Overview

Phase 2, randomised, open-label trial of haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen in meningococcal disease and Haemophilus influenzae type b infection (Hib) (3 arms), sponsored by GSK. Primary endpoints: Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter, Number of Subjects With Meningococcal Polysaccharide C Serum Bactericidal Activity/Assay Using Baby Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:128 and 4 more. Started Apr 2005; status: completed.

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Drugs

haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen
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Conditions

meningococcal diseaseHaemophilus influenzae type b infection (Hib)

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