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ROTATEQ Reexamination Study (V260-037)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01074242
First received: February 22, 2010
Last updated: April 1, 2015
Last verified: April 2015
Results First Received: February 11, 2014  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Gastroenteritis Rotavirus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Rotateq Korean infants vaccinated with Rotateq in usual practice

Participant Flow:   Overall Study
    Rotateq
STARTED   3798 
Received at Least 1 Dose of Vaccine   3395 
COMPLETED   3395 
NOT COMPLETED   403 
Case report before date of contract                40 
Lost to Follow-up                1 
Case report unclear                6 
Violation of vaccine dose or dosage                351 
Duplicate Case Report Form                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics were reported for all enrolled participants who received at least 1 dose of study vaccine

Reporting Groups
  Description
Rotateq Korean infants vaccinated with Rotateq in usual practice

Baseline Measures
   Rotateq 
Overall Participants Analyzed 
[Units: Participants]
 3395 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 9.57  (1.03) 
Age, Customized 
[Units: Participants]
 
<8 weeks   90 
Between 8 and 10 weeks   2740 
>10 weeks   565 
Gender 
[Units: Participants]
 
Female   1692 
Male   1703 


  Outcome Measures
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1.  Primary:   Percentage of Participants With Any Adverse Experience   [ Time Frame: Up to 42 days after any Rotateq vaccination ]

2.  Primary:   Percentage of Participants With Any Adverse Drug Reaction   [ Time Frame: Up to 42 days after any Rotateq vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01074242     History of Changes
Other Study ID Numbers: V260-037
2010_012 ( Other Identifier: Merck )
Study First Received: February 22, 2010
Results First Received: February 11, 2014
Last Updated: April 1, 2015
Health Authority: Korea: Food and Drug Administration