Trial intelligence / Profile preview

Menitorix Immunogenicity & Safety in Preterm & Full-term Infants

NCT00586612Phase 3Completed

Sponsor
GSK
Start
Dec 2007
Primary completion
Dec 2008
Modality
Vaccines & Immunotherapeutics
Countries
1
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Overview

Phase 3, open-label trial of Hib-MenC-TT in Haemophilus influenzae type b infection (Hib) and meningococcal disease (2 arms), sponsored by GSK. Primary endpoints: Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter and Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8. Started Dec 2007; status: completed.

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Drugs

Hib-MenC-TT
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Conditions

Haemophilus influenzae type b infection (Hib)meningococcal disease

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