Abstract
Immunogenicity and safety of a novel combined Haemophilus influenzae type b- Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine (Hib-MenCY-TT) candidate was evaluated when co-administered with DTPa-HBV-IPV( Pediarix™ 3 3 Pediarix is the Trademark of the GlaxoSmithKline group of companies. ) + PCV7( Prevnar™ 4 4 Prevnar is the Trademark of Wyeth. ) at 2–4–6 months of age. Anti-PRP concentrations ≥1.0 μg/mL were observed in 92.9–98.7%, rSBA-MenC/Y titres ≥1:8 in >98%, rSBA-MenC/Y titres ≥1:128 in >95.8 and >89.9% subjects. PRP and MenC responses were similar to respective controls ( ActHIB™ 5 5 ActHIB is the Trademark of Sanofi Pasteur. and Menjugate™ 6 6 Menjugate is the Trademark of Novartis. ) including for antibody persistence. Response to co-administered vaccines was not impaired. Polysaccharide challenge (PRP, PSC, PSY at 11–14 months of age) evidenced immune memory was induced for Hib, MenC/Y conjugate components. The safety profile of Hib-MenCY-TT was similar to controls. Hib-MenCY-TT administered according to the current US Hib vaccine schedule has the potential to induce protective antibodies against Hib and meningococcal-CY disease in infants and toddlers.
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