ROTATEQ Reexamination Study (V260-037)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT01074242

First received: February 22, 2010

Last updated: April 1, 2015

Last verified: April 2015

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

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Percentage of Participants With Any Adverse Experience [ Time Frame: Up to 42 days after any Rotateq vaccination ] [ Designated as safety issue: Yes ]
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.
Percentage of Participants With Any Adverse Drug Reaction [ Time Frame: Up to 42 days after any Rotateq vaccination ] [ Designated as safety issue: Yes ]
An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out


Enrollment:	3798
Study Start Date:	September 2007
Study Completion Date:	June 2013
Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility


Ages Eligible for Study:	6 Weeks to 32 Weeks (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT01074242 History of Changes
Other Study ID Numbers:	V260-037 2010_012
Study First Received:	February 22, 2010
Results First Received:	February 11, 2014
Last Updated:	April 1, 2015
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:


Gastroenteritis rotavirus

Additional relevant MeSH terms:


Gastroenteritis Gastrointestinal Diseases Digestive System Diseases

ClinicalTrials.gov processed this record on September 28, 2016

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