V260 Registration Study (V260-013)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00166517
First received: September 9, 2005
Last updated: May 1, 2014
Last verified: May 2014
Results First Received: July 6, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Rotavirus
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

The study was conducted at 8 sites.in Korea from 02-Aug-2005 (first patient in) to 25-May-2006 (last dose

given). Last subject completed follow-up: 05-Jul-2006. All data corrections applied (Frozen File) on 18-

Aug-2006


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

Subjects with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of

known prior rotavirus disease; ongoing chronic diarrhea or failure to thrive and those with clinical evidence

of active gastrointestinal illness were excluded.


Reporting Groups
  Description
RotaTeq™ Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
Placebo Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.

Participant Flow:   Overall Study
    RotaTeq™     Placebo  
STARTED     115     63  
Vaccinated at Visit 1     115     63  
Vaccinated at Visit 2     112     61  
Vaccinated at Visit 3     110     61  
COMPLETED     110     61  
NOT COMPLETED     5     2  
Lost to Follow-up                 1                 0  
Protocol Violation                 4                 1  
Withdrawal by Subject                 0                 1  



  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 oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
Placebo Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
Total Total of all reporting groups

Baseline Measures
    RotaTeq™     Placebo     Total  
Number of Participants  
[units: participants]
  115     63     178  
Age, Customized  
[units: participants]
     
6-12 Weeks of Age     114     63     177  
Over 12 Weeks of Age     1     0     1  
Gender  
[units: participants]
     
Female     46     30     76  
Male     69     33     102  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Serum Anti-Rotavirus IgA Response   [ Time Frame: Baseline and 14 days Postdose 3 ]

2.  Secondary:   Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A   [ Time Frame: Baseline and 14 days Postdose 3 ]


  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, Late Stage Development Group Leader
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: NCT00166517     History of Changes
Other Study ID Numbers: V260-013, 2005_071
Study First Received: September 9, 2005
Results First Received: July 6, 2009
Last Updated: May 1, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)