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: May 5, 2014
Last verified: May 2014
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
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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 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


  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 ]

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
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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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