ROTATEQ Reexamination Study (V260-037)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Gastroenteritis Rotavirus

Study type: Observational

Funder types: Industry

Identifiers

NCT01074242

V260-037

2010_012 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3,798 patients

Sex: All

Ages: 6 to 32 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

3,798 participants in 1 patient group

Rotateq

Description:

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.