Developing World Study for RotaTeq™
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00362648
First received: August 8, 2006
Last updated: April 26, 2010
Last verified: April 2010
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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
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
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
| 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 ] |