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ROTATEQ Reexamination Study (V260-037)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date February 22, 2010
First Posted Date February 24, 2010
Results First Submitted Date February 11, 2014
Results First Posted Date March 27, 2014
Last Update Posted Date April 13, 2017
Study Start Date September 2007
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 11, 2014)
  • 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.
  • 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
Original Primary Outcome Measures
 (submitted: February 22, 2010)
Percent of subjects with clinical and/or laboratory adverse events [ Time Frame: Day 0-42 after each vaccination ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ROTATEQ Reexamination Study (V260-037)
Official Title Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 6-32 week old Korean Infants who are vaccinated with Rotateq in usual practice
Condition Gastroenteritis Rotavirus
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 11, 2014)
3798
Original Estimated Enrollment
 (submitted: February 22, 2010)
3473
Actual Study Completion Date June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Weeks to 32 Weeks   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Korea, Republic of
 
Administrative Information
NCT Number NCT01074242
Other Study ID Numbers V260-037
2010_012 ( Other Identifier: Merck )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor Merck Sharp & Dohme Corp.
Collaborators Not Provided
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017