N/A
Completed N=3,798
ROTATEQ Reexamination Study (V260-037)
Gastroenteritis Rotavirus
Source: ClinicalTrials.gov NCT01074242 ↗
Enrolled (actual)
3,798
Serious AEs
0.2%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Participants With Any Adverse Experience — 22.12 Percent of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Any Adverse Experience |
22.12 | — |
| PRIMARY Percentage of Participants With Any Adverse Drug Reaction |
4.27 | — |
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
Data sourced from ClinicalTrials.gov (NCT01074242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.