Clinical Trial: Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Adsorbed to Alum (PATH-wSP) in Healthy Kenyan Adults and Toddlers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Dose-Finding Study to Assess the Safety, Tolerability, and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (PATH-wSP) in Healthy Kenyan Young Adults an
Brief Summary:
The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV).
Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.
Detailed Summary:
Sponsor: PATH
Current Primary Outcome: Proportion of subjects with reactogenicity events [ Time Frame: through 1 week post vaccination ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To evaluate the distribution of antibody concentrations in pre- and post-vaccination sera following each vaccination for pneumococcal-specific proteins and for neutralizing antibody responses [ Time Frame: Prior to the first vaccination compared to 1 week after each vaccination ]
Original Secondary Outcome: Same as current
Information By: PATH
Dates:
Date Received: March 17, 2014
Date Started: April 2014
Date Completion:
Last Updated: January 7, 2016
Last Verified: April 2015