Infectious Disease Clinical Trial
Official title:
A Phase 2, Multicenter, Randomized, Double-Blind, Immunogenicity, Reactogenicity, and Safety Study of NU300 Booster Dose Compared to ActHIB®, Both Co-administered With Prevnar 13® at 12-15 Months of Age, in Healthy Toddlers Who Have Received a Primary Series of a Licensed Hib Vaccine and Prevnar 13®
Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with
Prevnar 13® over a 28 day period following the injection compared to a single booster of
ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection.
Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single
booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of
ActHIB® co-administered with Prevnar 13®.
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®
following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to
the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28
days following injection.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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