ROTATEQ Reexamination Study (V260-037)
- Conditions
- Gastroenteritis Rotavirus
- Registration Number
- NCT01074242
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3798
- Infants Who Are Vaccinated With Rotateq For The Prevention Of Rotavirus Gastroenteritis Within Local Labeling Will Be Included
- Participants who are vaccinated with Rotateq before study start
- Participant who has a contraindication to Rotateq according to the local label
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Any Adverse Experience 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 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
- Secondary Outcome Measures
Name Time Method