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: February 11, 2014
Last verified: February 2014

February 22, 2010
February 11, 2014
September 2007
June 2013   (final data collection date for primary outcome measure)
  • 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
Percent of subjects with clinical and/or laboratory adverse events [ Time Frame: Day 0-42 after each vaccination ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01074242 on ClinicalTrials.gov Archive Site
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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.

Not Provided
Observational
Time Perspective: Prospective
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Probability Sample

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

Gastroenteritis Rotavirus
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3798
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
6 Weeks to 32 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01074242
V260-037, 2010_012
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP