Consistency Lots Vaccine Study (V260-009)

Phase 3

Completed

• Conditions: Rotavirus Infections
• Interventions: Biological: Placebo; Biological: rotavirus vaccine, live, oral, pentavalent

• Registration Number: NCT00092456
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Study First Submitted: 2004-09-22
• Study First Submitted QC: 2004-09-24
• Study First Posted: 2004-09-27
• Results First Submitted: 2009-06-19
• Results First Submitted QC: 2011-03-11
• Results First Posted: 2011-04-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-18
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 793

Inclusion Criteria

• Healthy infants

Exclusion Criteria

• History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
• Known or suspected problems with the immune system
• Fever at time of immunization
• Prior administration of a rotavirus vaccine
• History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
RotaTeq™ Lot 3	rotavirus vaccine, live, oral, pentavalent	\~6.91 X 10\^7 IU/Dose of RotaTeq™
RotaTeq™ Lot 2	rotavirus vaccine, live, oral, pentavalent	\~8.01 X 10\^7 IU/Dose of RotaTeq™
RotaTeq™ Lot 1	rotavirus vaccine, live, oral, pentavalent	\~8.81 X 10\^7 IU/Dose of RotaTeq™

Primary Outcome Measures

Name	Time	Method
Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]	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\[8\]