ROTATEQ Reexamination Study (V260-037)

Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Rotateq through collecting the safety information according to the Re-examination Regulation for New Drugs.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis Rotavirus

• Study Type: Observational
• Enrollment (Actual): 3798

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 7 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

6-32 week old Korean Infants who are vaccinated with Rotateq in usual practice

Description

Inclusion Criteria:

• Infants Who Are Vaccinated With Rotateq For The Prevention Of Rotavirus Gastroenteritis Within Local Labeling Will Be Included

Exclusion Criteria:

• Participants who are vaccinated with Rotateq before study start
• Participant who has a contraindication to Rotateq according to the local label

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Rotateq; Korean Infants vaccinated with Rotateq in usual practice. The Rotateq vaccination series consists of 3 ready-to-use liquid (oral) doses with the first dose to be administered at age 6-12 weeks and subsequent doses to be administered at 4 to 10-week intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Any Adverse Experience	An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.	Up to 42 days after any Rotateq vaccination
Percentage of Participants With Any Adverse Drug Reaction	An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out	Up to 42 days after any Rotateq vaccination

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 22, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 24, 2010

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: March 16, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Gastroenteritis rotavirus
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: V260-037; 2010_012 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis