A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)

This study has been terminated.
(Strategic business decision not to pursue indication due to lack of demonstrable medical need)
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00836498
First received: February 3, 2009
Last updated: February 24, 2011
Last verified: February 2011
Results First Received: January 12, 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
Interventions: Biological: Comparator: RotaTeq
Biological: Comparator: Placebo
Biological: Comparator: RotaTeq + 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
Enrollment of participants occurred at 8 study sites in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Part II was not conducted; no participants were recruited.

Reporting Groups
  Description
RotaTeq™ Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
Placebo Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.

Participant Flow:   Overall Study
    RotaTeq™     Placebo  
STARTED     44     22  
COMPLETED     40 [1]   21  
NOT COMPLETED     4     1  
Adverse Event                 1                 0  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 2                 1  
[1] Participant who discontinued the study vaccination due to AE completed the 180-day safety follow-up.



  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 dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
Placebo Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
Total Total of all reporting groups

Baseline Measures
    RotaTeq™     Placebo     Total  
Number of Participants  
[units: participants]
  44     22     66  
Age, Customized [1]
[units: participants]
  44     22     66  
Gender  
[units: participants]
     
Female     23     13     36  
Male     21     9     30  
Region of Enrollment  
[units: participants]
     
United States     44     22     66  
[1] Between 65 and 80 years.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs)   [ Time Frame: Up to 42 days following any dose of RotaTeq™ or placebo ]

2.  Primary:   Part I: Number of Participants With Serious Adverse Experiences (SAEs)   [ Time Frame: Up to 180 days following the third dose of RotaTeq™ or placebo ]

3.  Primary:   Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)   [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

4.  Primary:   Part II: Number of Participants With Nonserious Adverse Experiences   [ Time Frame: Up to 42 days following any dose of RotaTeq™ and/or placebo ]

5.  Primary:   Part II: Number of Participants With Serious Adverse Experiences   [ Time Frame: Up to 180 days following the third dose of RotaTeq™ and/or placebo ]

6.  Primary:   Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)   [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 ]

7.  Secondary:   Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1   [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

8.  Secondary:   Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2   [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

9.  Secondary:   Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3   [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

10.  Secondary:   Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4   [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

11.  Secondary:   Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]   [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

12.  Secondary:   Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A   [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 ]

13.  Secondary:   Part II: Percentage of Participants With a >=3-fold Rise From Baseline of Serum Anti-rotavirus IgA and SNA Responses to Rotavirus Serotypes G1, G2, G3, G4 and P1A   [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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


No publications provided


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00836498     History of Changes
Other Study ID Numbers: V260-027, 2007_537
Study First Received: February 3, 2009
Results First Received: January 12, 2011
Last Updated: February 24, 2011
Health Authority: United States: Food and Drug Administration