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ROTATEQ Reexamination Study (V260-037 AM3)

This study is currently recruiting participants.
Verified March 2013 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01074242
First received: February 22, 2010
Last updated: March 22, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
Gastroenteritis Rotavirus

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis
Drug Information available for: Rotarix
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Percentage of participants with any adverse experience [ Time Frame: During or within 42 days following the first vaccination and from the time of any subsequent vaccination through 42 days thereafter ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3600
Study Start Date: September 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Korean Infants vaccinated with Rotateq

  Eligibility

Ages Eligible for Study:   6 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074242

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
Korea, Republic of
MSD Korea LTD Recruiting
Seoul, Korea, Republic of
Contact: Yong Soo (STEVE) Kim     82 2 331 2014        
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01074242     History of Changes
Other Study ID Numbers: V260-037, 2010_012
Study First Received: February 22, 2010
Last Updated: March 22, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck:
Gastroenteritis rotavirus

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013