Clinical Trial: Dose Confirmation Efficacy Study (V260-007)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry

Brief Summary: This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

Detailed Summary: The duration of treatment is 10 months.
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. [ Time Frame: At least 14 days following the 3rd vaccination ]

G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition


Original Primary Outcome:

Current Secondary Outcome: Number of Subjects With ≥3 Fold Rise in Antibody Titer [ Time Frame: 14 days following the 3rd vaccination ]

Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)


Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: September 22, 2004
Date Started: September 2002
Date Completion:
Last Updated: September 11, 2015
Last Verified: September 2015