Gastroenteritis Rotavirus Clinical Trial
Official title:
Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice
| Verified date | April 2015 |
| Source | Merck Sharp & Dohme Corp. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 3798 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Weeks to 32 Weeks |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme Corp. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Any Adverse Experience | 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. | Up to 42 days after any Rotateq vaccination | Yes |
| Primary | Percentage of Participants With Any Adverse Drug Reaction | An adverse drug reaction was an adverse experience for which a causal relationship to the study drug could not be ruled out | Up to 42 days after any Rotateq vaccination | Yes |