NCT00092456

Consistency Lots Vaccine Study (V260-009)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 793 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

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

Conditions

• Rotavirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	rotavirus vaccine, live, oral, pentavalent	Three oral doses (\~8.81 X 10\^7 IU/Dose for Lot 1; \~8.01 X 10\^7 IU/Dose for Lot 2; and \~6.91 X 10\^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
BIOLOGICAL	Placebo	Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination

Timeline

• Start date: 2003-05-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2004-09-27
• Last updated: 2015-10-05
• Results posted: 2011-04-12