Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00362648
First received: August 8, 2006
Last updated: November 4, 2013
Last verified: November 2013
Results First Received: March 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Vomiting
Diarrhea
Fever
Interventions: Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
Biological: Comparator: Placebo

  Participant Flow
  Hide Participant Flow

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 5 international sites – Ghana, Kenya, Mali, Bangladesh, and Vietnam from 29 March 2007 (first patient in) to 13 October 2008 (last dose given).

Last subject completed follow-up: 31 March 2009

All data corrections applied (Frozen File): 20 July 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 active gastrointestinal illness (vomiting, diarrhea, elevated temperature); who were participating in (or expected to participate in) other investigational-product studies; who could not be followed adequately for safety.

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

Participant Flow:   Overall Study
    RotaTeq™ - Africa     Placebo - Africa     RotaTeq™ - Asia     Placebo - Asia  
STARTED     2733 [1]   2735 [1]   1018 [1]   1018 [1]
Vaccinated at Visit 1     2733     2735     1018     1018  
Vaccinated at Visit 2     2657     2666     1013     1009  
Vaccinated at Visit 3     2613     2612     1009     1007  
COMPLETED     2607 [2]   2601 [2]   1009 [2]   1007 [2]
NOT COMPLETED     126     134     9     11  
Adverse Event                 12                 21                 1                 0  
Lost to Follow-up                 62                 69                 4                 3  
Protocol Violation                 4                 2                 2                 2  
Withdrawal by Subject                 48                 42                 2                 6  
[1] Subjects who passed all entry criteria and who were randomized in to the study
[2] Subjects vaccinated and followed up to 14 days after each dose



  Baseline Characteristics
  Hide Baseline Characteristics

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

Baseline Measures
    RotaTeq™ - Africa     Placebo - Africa     RotaTeq™ - Asia     Placebo - Asia     Total  
Number of Participants  
[units: participants]
  2733     2735     1018     1018     7504  
Age, Customized  
[units: participants]
         
<27 Days     0     1     0     0     1  
27 to 41 Days     536     569     3     7     1115  
42 to 84 Days     2197     2165     1015     1011     6388  
Gender  
[units: participants]
         
Female     1359     1370     464     492     3685  
Male     1374     1365     554     526     3819  
Race/Ethnicity, Customized  
[units: participants]
         
Black     2733     2735     0     0     5468  
Asian     0     0     1017     1016     2033  
Multi-Racial     0     0     1     2     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose   [ Time Frame: At least 14 days following the third vaccination ]

2.  Secondary:   Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]   [ Time Frame: 14 days following the 3rd vaccination ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Measure Description Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
Time Frame 14 days following the 3rd vaccination  
Safety Issue Yes  

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.

Per Protocol Population

*N analyzed for Serotype P1A[8] is 188


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

Measured Values
    RotaTeq™ - Africa     Placebo - Africa  
Number of Participants Analyzed  
[units: participants]
  189     169  
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]  
[units: Subjects]
   
≥ 3 fold rise in anti-rotavirus IgA     148     34  
≥ 3 fold rise in antibody titer: Serotype G1     35     0  
≥ 3 fold rise in antibody titer: Serotype G2     17     5  
≥ 3 fold rise in antibody titer: Serotype G3     12     4  
≥ 3 fold rise in antibody titer: Serotype G4     50     4  
≥ 3 fold rise in antibody titer: Serotype P1A[8]     27     8  


Statistical Analysis 1 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] RotaTeq™ - Africa
Percentage [2] 78.3
95% Confidence Interval ( 71.7 to 84.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Anti-rotavirus IgA
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] RotaTeq™ - Africa
Percentage [2] 18.5
95% Confidence Interval ( 13.3 to 24.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype G1
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] RotaTeq™ - Africa
Percentage [2] 9.0
95% Confidence Interval ( 5.3 to 14.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype G2
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] RotaTeq™ - Africa
Percentage [2] 6.3
95% Confidence Interval ( 3.3 to 10.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype G3
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] RotaTeq™ - Africa
Percentage [2] 26.5
95% Confidence Interval ( 20.3 to 33.3 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype G4
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] RotaTeq™ - Africa
Percentage [2] 14.4
95% Confidence Interval ( 9.7 to 20.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype P1A[8]
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] Placebo - Africa
Percentage [2] 20.1
95% Confidence Interval ( 14.4 to 27.0 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Anti-rotavirus IgA
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] Placebo - Africa
Percentage [2] 0.0
95% Confidence Interval ( 0.0 to 2.2 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype G1
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] Placebo - Africa
Percentage [2] 3.0
95% Confidence Interval ( 1.0 to 6.8 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype G2
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] Placebo - Africa
Percentage [2] 2.4
95% Confidence Interval ( 0.6 to 5.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype G3
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] Placebo - Africa
Percentage [2] 2.4
95% Confidence Interval ( 0.6 to 5.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype G4
[2] Other relevant estimation information:
  No text entered.

Statistical Analysis 12 for Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Groups [1] Placebo - Africa
Percentage [2] 4.7
95% Confidence Interval ( 2.1 to 9.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Serotype P1A[8]
[2] Other relevant estimation information:
  No text entered.



3.  Secondary:   Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]   [ Time Frame: 14 days following the 3rd vaccination ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00362648     History of Changes
Other Study ID Numbers: V260-015, 2006_027
Study First Received: August 8, 2006
Results First Received: March 11, 2010
Last Updated: November 4, 2013
Health Authority: Ghana: Ministry of Health