A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00953056
First received: August 4, 2009
Last updated: August 8, 2013
Last verified: August 2013
Results First Received: March 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Rotavirus Gastroenteritis
Interventions: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Biological: Comparator: Placebo

  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
A total of 144 participants were enrolled; 48 in each of 3 cohorts. This study was conducted sequentially in the 3 different Cohorts, Chinese adults (Cohort I) first, followed by children (Cohort II), and then infants (Cohort III).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort I - RotaTeq™, Adults Adults randomized to receive a single dose of RotaTeq™.
Cohort I - Placebo, Adults Adults randomized to receive a single dose of matching placebo to RotaTeq™.
Cohort II - RotaTeq™, Children Children randomized to receive a single dose of RotaTeq™.
Cohort II - Placebo, Children Children randomized to receive a single dose of matching placebo to RotaTeq™.
Cohort III - RotaTeq™, Infants Infants randomized to receive 3 doses of RotaTeq™.
Cohort III - Placebo, Infants Infants randomized to receive 3 doses of matching placebo to RotaTeq™.

Participant Flow:   Overall Study
    Cohort I - RotaTeq™, Adults     Cohort I - Placebo, Adults     Cohort II - RotaTeq™, Children     Cohort II - Placebo, Children     Cohort III - RotaTeq™, Infants     Cohort III - Placebo, Infants  
STARTED     24     24     24     24     24     24  
COMPLETED     24     24     24     24     22 [1]   20  
NOT COMPLETED     0     0     0     0     2     4  
Withdrew Consent                 0                 0                 0                 0                 2                 3  
Serious Adverse Event                 0                 0                 0                 0                 0                 1  
[1] One participant received placebo at the second dose in error, but completed the study.



  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
Cohort I - RotaTeq™, Adults Adults randomized to receive a single dose of RotaTeq™.
Cohort I - Placebo, Adults Adults randomized to receive a single dose of matching placebo to RotaTeq™.
Cohort II - RotaTeq™, Children Children randomized to receive a single dose of RotaTeq™.
Cohort II - Placebo, Children Children randomized to receive a single dose of matching placebo to RotaTeq™.
Cohort III - RotaTeq™, Infants Infants randomized to receive 3 doses of RotaTeq™.
Cohort III - Placebo, Infants Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
Total Total of all reporting groups

Baseline Measures
    Cohort I - RotaTeq™, Adults     Cohort I - Placebo, Adults     Cohort II - RotaTeq™, Children     Cohort II - Placebo, Children     Cohort III - RotaTeq™, Infants     Cohort III - Placebo, Infants     Total  
Number of Participants  
[units: participants]
  24     24     24     24     24     24     144  
Age, Customized [1]
[units: participants]
             
6 weeks to 12 weeks (infants)     0     0     0     0     24     24     48  
2 years to 5 years (children)     0     0     24     24     0     0     48  
19 years to 49 years (adults)     24     24     0     0     0     0     48  
Gender  
[units: participants]
             
Female     13     17     10     11     8     11     70  
Male     11     7     14     13     16     13     74  
Region of Enrollment  
[units: participants]
             
China     24     24     24     24     24     24     144  
[1] The inclusion criterion for Cohort I (adults) in this study was 19-47 years. However, one participant who was 49 years at study entry was randomized.



  Outcome Measures
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1.  Primary:   Number of Participants With Serious Adverse Events   [ Time Frame: up to 14 days post vaccination ]

2.  Primary:   Number of Serious Adverse Events   [ Time Frame: 14 days post vaccination ]

3.  Secondary:   Number of Infants With Fecal Vaccine Virus Shedding   [ Time Frame: Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp and Dohme
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00953056     History of Changes
Other Study ID Numbers: V260-028, 2009_627
Study First Received: August 4, 2009
Results First Received: March 25, 2011
Last Updated: August 8, 2013
Health Authority: China: Ministry of Health