ROTATEQ Reexamination Study (V260-037)

Merck Sharp & Dohme LLC3,798 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,798

Conditions

Gastroenteritis Rotavirus

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 32 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Up to 42 days after any Rotateq vaccination

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

Time frame: Up to 42 days after any Rotateq vaccination

Data from ClinicalTrials.gov

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