ROTATEQ Reexamination Study (V260-037)

• 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: Merck Sharp & Dohme Corp.
• 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 ]
• 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

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