Clinical Trial: Consistency Lots Vaccine Study (V260-009)

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

Official Title: Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants

Brief Summary: This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] [ Time Frame: 42 days following the 3rd vaccination ]

Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8]


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: September 22, 2004
Date Started: May 2003
Date Completion:
Last Updated: September 18, 2015
Last Verified: September 2015