Clinical Trial: Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001 EXT1)(COMPLETED)
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™ in Healthy Adults and Toddlers
Brief Summary: This study is being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent Pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers.
Detailed Summary: The study was extended to obtain additional sera from adult participants to support further development, validation, and performance of anti-pneumococcal antibody assays.
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome:
- Number of adult participants reporting adverse events [ Time Frame: Up to 30 days post-vaccination ]
- Number of toddler participants reporting adverse events [ Time Frame: Up to 30 days post-vaccination ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Immunogenicity response to the serotypes contained in V114 in both adult and toddler participants [ Time Frame: Baseline and 30 days post-vaccination ]
Original Secondary Outcome: Immunogenicity response to the serotypes contained in V114 in both adult and toddlers. [ Time Frame: Baseline and Day 30 post-vaccination. ]
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: October 4, 2010
Date Started: September 2009
Date Completion:
Last Updated: April 20, 2015
Last Verified: April 2015
