ROTATEQ Reexamination Study (V260-037)

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.

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Key information

Conditions

Gastroenteritis Rotavirus

Age range

6 week–32 week

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice

Important dates

Study start: 2007
Primary completion: 2013
Study completion: 2013
First posted: Feb 24, 2010
Registry last updated: Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.