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ROTATEQ Reexamination Study (V260-037)

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ClinicalTrials.gov Identifier: NCT01074242
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : March 27, 2014
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
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 or disease
Gastroenteritis Rotavirus

Study Design
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Study Type : Observational
Actual Enrollment : 3798 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice
Study Start Date : September 2007
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis
U.S. FDA Resources

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Any Adverse Experience [ Time Frame: Up to 42 days after any Rotateq vaccination ]
    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.

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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074242


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01074242     History of Changes
Other Study ID Numbers: V260-037
2010_012 ( Other Identifier: Merck )
First Posted: February 24, 2010    Key Record Dates
Results First Posted: March 27, 2014
Last Update Posted: April 13, 2017
Last Verified: March 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Gastroenteritis rotavirus

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases