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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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Gastroenteritis Rotavirus
Enrollment 3798
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rotateq
Hide Arm/Group Description Korean infants vaccinated with Rotateq in usual practice
Period Title: Overall Study
Started 3798
Received at Least 1 Dose of Vaccine 3395
Completed 3395
Not Completed 403
Reason Not Completed
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
Arm/Group Title Rotateq
Hide Arm/Group Description Korean infants vaccinated with Rotateq in usual practice
Overall Number of Baseline Participants 3395
Hide Baseline Analysis Population Description
Baseline characteristics were reported for all enrolled participants who received at least 1 dose of study vaccine
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 3395 participants
9.57  (1.03)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 3395 participants
<8 weeks 90
Between 8 and 10 weeks 2740
>10 weeks 565
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3395 participants
Female
1692
  49.8%
Male
1703
  50.2%
1.Primary Outcome
Title Percentage of Participants With Any Adverse Experience
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study vaccine were included in the analysis
Arm/Group Title Rotateq
Hide Arm/Group Description:
Korean infants vaccinated with Rotateq in usual practice
Overall Number of Participants Analyzed 3395
Measure Type: Number
Unit of Measure: Percent of participants
22.12
2.Primary Outcome
Title Percentage of Participants With Any Adverse Drug Reaction
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who received at least 1 dose of study vaccine were included in the analysis
Arm/Group Title Rotateq
Hide Arm/Group Description:
Korean infants vaccinated with Rotateq in usual practice
Overall Number of Participants Analyzed 3395
Measure Type: Number
Unit of Measure: Percent of participants
4.27
Time Frame Up to 42 days after any Rotateq vaccination
Adverse Event Reporting Description All enrolled participants who received at least 1 dose of study vaccine were included in the analysis
 
Arm/Group Title Rotateq
Hide Arm/Group Description Korean infants vaccinated with Rotateq in usual practice
All-Cause Mortality
Rotateq
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Rotateq
Affected / at Risk (%) # Events
Total   8/3395 (0.24%)    
Gastrointestinal disorders   
Enteritis 1  1/3395 (0.03%)  1
General disorders   
Pyrexia 1  1/3395 (0.03%)  1
Infections and infestations   
Gastroenteritis 1  1/3395 (0.03%)  1
Laryngitis 1  1/3395 (0.03%)  1
Pneumonia 1  3/3395 (0.09%)  4
Urinary tract infection 1  3/3395 (0.09%)  3
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rotateq
Affected / at Risk (%) # Events
Total   210/3395 (6.19%)    
Infections and infestations   
Nasopharyngitis 1  210/3395 (6.19%)  263
1
Term from vocabulary, MedDRA 16.0
[Not Specified]
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.
In regard to surveillance results, any publication should be agreed by the sponsor in advance
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01074242    
Other Study ID Numbers: V260-037
2010_012 ( Other Identifier: Merck )
First Submitted: February 22, 2010
First Posted: February 24, 2010
Results First Submitted: February 11, 2014
Results First Posted: March 27, 2014
Last Update Posted: April 13, 2017