Dose Confirmation Efficacy Study (V260-007)

Phase 3

Completed

• Conditions: Rotavirus Infections
• Interventions: Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalent

• Registration Number: NCT00092443
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

The duration of treatment is 10 months.

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2004-06
• Study Completion: 2004-06
• Study First Submitted: 2004-09-22
• Study First Submitted QC: 2004-09-24
• Study First Posted: 2004-09-27
• Results First Submitted: 2009-05-19
• Results First Submitted QC: 2009-05-19
• Results First Posted: 2009-07-10
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-11
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1312

Inclusion Criteria

• Healthy infants

Exclusion Criteria

• History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
• Known or suspected problems with 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
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)	RotaTeq™, rotavirus vaccine, live, oral, pentavalent	Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart.

Primary Outcome Measures

Name	Time	Method
Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.	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

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With ≥3 Fold Rise in Antibody Titer	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)