Clinical Trial: A Study of Pneumococcal Conjugate Vaccine (V114) Compared to a Marketed Vaccine (V114-003 AM2)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar 13™ in Healthy Infants
Brief Summary: This study will evaluate whether the aluminum-adjuvanted or the non-adjuvanted formulation of the candidate pneumococcal vaccine (V114) is non-inferior to Prevnar 13™ based on immune responses to the 13 serotypes in common Prevnar 13™
Detailed Summary: A primary reason why this study was amended was to extend the comparison between V114 and Prevnar 13™ to all 13 serotypes in common, and to evaluate the response after dose 4 as a primary outcome measure.
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome:
- The number of participants receiving V114 and Prevnar 13™ who meet the WHO-defined IgG (immunoglobulin G) antibody level for each of the 13 serotypes in common with Prevnar 13™ [ Time Frame: 30 days post-dose (dose 3) ]
- Geometric Mean Concentrations (GMCs) of the antibody response to each of the 13 serotypes in common with Prevnar 13™ [ Time Frame: 30 days post-dose (dose 3 and dose 4) ]
Original Primary Outcome: Determine the proportion of participants receiving V114 and Prevnar 13™ who meet the WHO-defined IgG (immunoglobulin G) antibody level post-dose 3 for each of the 7 serotypes in common with 7-valent Prevnar™ [ Time Frame: 30 days postdose (dose 3) ]
Current Secondary Outcome: The number of participants receiving V114 and Prevnar 13™ who meet the WHO-defined IgG antibody levels for the 2 serotypes not in common with Prevnar 13™ [ Time Frame: 30 days post-dose (dose 3 and dose 4) ]
Original Secondary Outcome:
- Determine the proportion of participants receiving V114 and Prevnar 13™ who meet the WHO-defined IgG antibody level post-dose 3 for each of the 6 serotypes in common with Prevnar 13™ [ Time Frame: 30 days postdose (dose 3) ]
- Determine the proportion of participants receiving V114 and Prevnar 13™ who meet the WHO-defined IgG antibody levels post-dose 3 for 2 serotypes not in common with Prevnar 13™ [ Time Frame: 30 days postdose (dose 3) ]
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: October 4, 2010
Date Started: October 2010
Date Completion:
Last Updated: December 29, 2014
Last Verified: December 2014