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Dose Confirmation Efficacy Study (V260-007)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00092443
First received: September 22, 2004
Last updated: October 13, 2011
Last verified: October 2011
History of Changes
Results First Received: May 19, 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 Infections
Interventions: Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalent
Biological: Comparator: Placebo matching RotaTeq™

  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 30 sites - 27 in the United States, and 3 in Finland from 24-Sep-2002 (first patient in) to 11-Feb-2004 (last dose given). Last subject completed follow-up: 08-Jun-2004. All data corrections applied (Frozen File): 07-Sep-2004

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 patients with: history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive.

Reporting Groups
  Description
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) Three 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, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
Placebo Matching RotaTeq™ Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.

Participant Flow:   Overall Study
    RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)     Placebo Matching RotaTeq™  
STARTED     651 [1]   661 [1]
Vaccinated at Visit 1     650     660  
Vaccinated at Visit 2     618     627  
Vaccinated at Visit 3     593     608  
COMPLETED     593 [2]   607 [2]
NOT COMPLETED     58     54  
Adverse Event                 9                 13  
Lost to Follow-up                 7                 3  
Protocol Violation                 11                 9  
Withdrawal by Subject                 9                 11  
Moved                 5                 5  
Not Specified                 17                 13  
[1] Subjects who passed all entry criteria and who were randomized in to the study
[2] Subjects vaccinated and followed up 42 days after each dose, thru 1st rotavirus season post study



  Baseline Characteristics
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Reporting Groups
  Description
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) Three 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, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
Placebo Matching RotaTeq™ Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
Total Total of all reporting groups

Baseline Measures
    RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)     Placebo Matching RotaTeq™     Total  
Number of Participants  
[units: participants]
 		  651     661     1312  
Age, Customized  
[units: participants]
 		     
6 to 12 Weeks     648     658     1306  
Over 12 Weeks     3     3     6  
Gender  
[units: participants]
 		     
Female     304     323     627  
Male     347     338     685  
Race/Ethnicity  
[units: participants]
 		     
White     525     540     1065  
Hispanic American     79     77     156  
Black     21     23     44  
Multi-Racial     17     15     32  
Other     9     6     15  



  Outcome Measures
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1.  Primary:   Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.   [ Time Frame: At least 14 days following the 3rd vaccination ]
  Show Outcome Measure 1

2.  Secondary:   Number of Subjects With ≥3 Fold Rise in Antibody Titer   [ Time Frame: 14 days following the 3rd vaccination ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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.


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
Safety has been reported in the literature.  


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:


Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00092443     History of Changes
Other Study ID Numbers: V260-007, 2004_077
Study First Received: September 22, 2004
Results First Received: May 19, 2009
Last Updated: October 13, 2011
Health Authority: United States: Food and Drug Administration