Safety and Immunogenicity of Hib-MenCY-TT Vaccine Formulations in Infants

Phase 2, randomised, open-label trial of haemophilus influenzae type b capsular polysaccharide meningococcal outer membrane protein conjugate antigen in Haemophilus influenzae type b infection (Hib) and meningococcal disease (5 arms), sponsored by GSK. Primary endpoints: Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter at Month 5, Number of Subjects With Serum Bactericidal Activity Using Baby Rabbit Complement (rSBA)- Neisseria Meningitidis Serogroup C (MenC) Titers Greater Than or Equal to 1:8 at Month 5 and 1 more. Started Mar 2003; status: completed.