We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00362648
First Posted: August 10, 2006
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: March 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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 
Overall Participants Analyzed 
[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 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      1359  49.7%      1370  50.1%      464  45.6%      492  48.3%      3685  49.1% 
Male      1374  50.3%      1365  49.9%      554  54.4%      526  51.7%      3819  50.9% 
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  

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 
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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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
Statistical Test Type [2] Superiority or Other
Percentage [3] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] 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


  Limitations and Caveats
  Hide 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.


  More Information