V260 Registration Study (V260-013)(COMPLETED)

Phase 3

Completed

• Conditions: Rotavirus
• Interventions: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent

• Registration Number: NCT00166517
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Immunogenicity and Safety of V260 in Healthy Infants in Korea

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Results First Submitted: 2009-07-06
• Results First Submitted QC: 2009-08-13
• Results First Posted: 2009-09-23
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• At first study vaccination, age 6 weeks through exactly 12 weeks

Exclusion Criteria

• History of congenital abdominal disorders, intussusception, or abdominal surgery
• History of known prior rotavirus disease
• Ongoing chronic diarrhea or failure to thrive
• Clinical evidence of active gastrointestinal illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rotavirus Vaccine, Live, Oral, Pentavalent	RotaTeq

Primary Outcome Measures

Name	Time	Method
Serum Anti-Rotavirus IgA Response	Baseline and 14 days Postdose 3	Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in; Serum IgA 14 days Postdose 3

Secondary Outcome Measures

Name	Time	Method
Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A	Baseline and 14 days Postdose 3	Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in; SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3