ROTATEQ Reexamination Study (V260-037)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01074242|
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : March 27, 2014
Last Update Posted : April 13, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||3798 participants|
|Official Title:||Re-examination Study for General Vaccine Use to Assess the Safety Profile of ROTATEQ in Usual Practice|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Korean Infants vaccinated with Rotateq in usual practice. The Rotateq vaccination series consists of 3 ready-to-use liquid (oral) doses with the first dose to be administered at age 6-12 weeks and subsequent doses to be administered at 4 to 10-week intervals.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074242
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|