Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00718237
First received: July 16, 2008
Last updated: June 3, 2014
Last verified: June 2014
Results First Received: June 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Rotavirus
Gastroenteritis
Interventions: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
Biological: Comparator: Comparator: Placebo (unspecified)

  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
The study was conducted at 32 sites in Japan from 2008 to 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Excluded from the trial before assignment to groups were subjects with: history of congenital abdominal

disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea,

or failure to thrive; immune impairment or resides in a household with an individual with an immune impairment.


Reporting Groups
  Description
RotaTeq™ Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Placebo Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.

Participant Flow:   Overall Study
    RotaTeq™     Placebo  
STARTED     381 [1]   381 [1]
Vaccinated at Visit 1     380     381  
Vaccinated at Visit 2     373     374  
Vaccinated at Visit 3     371     369  
COMPLETED     368 [2]   366 [2]
NOT COMPLETED     13     15  
Adverse Event                 1                 3  
Lost to Follow-up                 2                 2  
Physician Decision                 1                 0  
Withdrawal by Subject                 9                 10  
[1] Subjects who passed all entry criteria and who were randomized into the study
[2] Subjects who continued follow-up until the last visit, regardless of number of vaccinations received



  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.
No text entered.

Reporting Groups
  Description
RotaTeq™ Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Placebo Three doses of placebo matching RotaTeq™ administered 28 to 70 days apart, with 14 days of follow-up after each vaccination, and follow-up for AGEs until the end of the study.
Total Total of all reporting groups

Baseline Measures
    RotaTeq™     Placebo     Total  
Number of Participants  
[units: participants]
  381     381     762  
Age  
[units: Weeks]
Mean ± Standard Deviation
  7.6  ± 1.7     7.5  ± 1.6     7.5  ± 1.6  
Age, Customized  
[units: participants]
     
6 to 12 Weeks of age     381     381     762  
Gender  
[units: participants]
     
Female     173     182     355  
Male     208     199     407  



  Outcome Measures
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1.  Primary:   Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A   [ Time Frame: At least 14 days following the 3rd vaccination ]

2.  Secondary:   Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A   [ Time Frame: At least 14 days following the 3rd vaccination ]

3.  Secondary:   Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A   [ Time Frame: At least 14 days following the 3rd 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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00718237     History of Changes
Other Study ID Numbers: V260-029, 2008_014
Study First Received: July 16, 2008
Results First Received: June 23, 2010
Last Updated: June 3, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency