Trial · NCT00090233
Rotavirus Efficacy and Safety Trial (REST)(V260-006)
NCT00090233, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2011-05-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rotavirus Efficacy and Safety Trial (REST)(V260-006). Trials, record NCT00090233. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00090233
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rotavirus Efficacy and Safety Trial (REST)(V260-006)
- NCT number
- NCT00090233
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 69,274 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Rotavirus Infections
- Interventions
- Rotateq™, Comparator: Placebo
- First posted
- 2004-08-27
- Last updated
- 2015-10-05
- Results first posted
- 2011-05-05
- Limitations and caveats
- 70,301 participants randomized, 69,274 evaluated, when DSMB first recommended ending enrollment.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo | Within 42 days following any dose of RotaTeq™/placebo | Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo. |
| Primary | Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination | At least 14 days following the 3rd vaccination through the first full rotavirus season | Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case. |
| Secondary | G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus | 14 days following the 3rd vaccination | Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3. |
| Secondary | Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4 | At least 14 days following the 3rd vaccination | Health Outcomes Substudy - Occurrence of hospital admissions and emergency department visits for episode(s) of rotavirus gastroenteritis associated with serotypes G1, G2, G3, or G4 by treatment group. Occurrence was expressed as the annual number of events per 1000 person-years. |
| Secondary | Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose. | At least 14 days following the 3rd vaccination through the first rotavirus season | Number of participants with rotavirus gastroenteritis whose clinical score was \>8 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \[range: total score 0 (best) to 24 (worst)\]. |
| Secondary | Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose | At least 14 days following the 3rd vaccination through the first rotavirus season | Number of participants with rotavirus gastroenteritis whose clinical score was \>16 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \[range: total score 0 (best) to 24 (worst)\]. |
| Secondary | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | 42 days following third dose | The number of participants who achieved seroprotection/seroconversion to hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, \& polio types 1, 2, \& 3, per established criteria. |
| Secondary | Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin | 42 days following third dose | Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin. Antibody titers were measured with an indirect, non-competitive, enzyme immunoassay (EIA). |
| Secondary | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | 42 days following third dose | Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Serum antibody titers to type-specific pneumococcal polysaccharides were determined by an EIA. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo | Within 42 days following any dose of RotaTeq™/placebo | All participants in the study were followed for potential cases of intussusception. | Participants | NUMBER |
| SECONDARY | G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus | 14 days following the 3rd vaccination | Per Protocol Population among participants in Finland using Per-Protocol Case Definition | Participants | NUMBER |
| PRIMARY | Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination | At least 14 days following the 3rd vaccination through the first full rotavirus season | Per Protocol Population Using Per-Protocol Case Definition | Participants | NUMBER |
| SECONDARY | Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4 | At least 14 days following the 3rd vaccination | Per Protocol Population Using Per-Protocol Case Definition | Annual # of events per 1000 person-years | NUMBER |
| SECONDARY | Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose. | At least 14 days following the 3rd vaccination through the first rotavirus season | Per Protocol Population Using Per-Protocol Case Definition | Participants | NUMBER |
| SECONDARY | Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose | At least 14 days following the 3rd vaccination through the first rotavirus season | Per Protocol Population Using Per-Protocol Case Definition | Participants | NUMBER |
| SECONDARY | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | 42 days following third dose | Per Protocol Population | Participants | NUMBER |
| SECONDARY | Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin | 42 days following third dose | Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations. | ELISA units/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | 42 days following third dose | Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations. | micrograms/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo | RotaTeq™ | 6 | Participants | ||
| Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo | Placebo | 5 | Participants | ||
| G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus | RotaTeq™ | 95 | Participants | ||
| G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus | Placebo | 8 | Participants | ||
| Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination | RotaTeq™ | 82 | Participants | ||
| Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination | Placebo | 315 | Participants | ||
| Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4 | RotaTeq™ | Hospital admissions | 6 | Annual # of events per 1000 person-years | |
| Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4 | Placebo | Hospital admissions | 144 | Annual # of events per 1000 person-years | |
| Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4 | RotaTeq™ | Emergency department visits | 14 | Annual # of events per 1000 person-years | |
| Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4 | Placebo | Emergency department visits | 213 | Annual # of events per 1000 person-years |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RotaTeq™ | 34,644 | |
| Overall Study | STARTED | Placebo | 34,630 | |
| Overall Study | Vaccinated at Visit 1 | RotaTeq™ | 34,035 | |
| Overall Study | Vaccinated at Visit 1 | Placebo | 34,003 | |
| Overall Study | Vaccinated at Visit 2 | RotaTeq™ | 31,052 | |
| Overall Study | Vaccinated at Visit 2 | Placebo | 31,066 | |
| Overall Study | Vaccinated at Visit 3 | RotaTeq™ | 29,667 | |
| Overall Study | Vaccinated at Visit 3 | Placebo | 29,598 | |
| Overall Study | COMPLETED | RotaTeq™ | 29,645 | |
| Overall Study | COMPLETED | Placebo | 29,565 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events758
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctivitis | Eye disorders | RotaTeq™ | 315 | 4,800 | |
| other | Conjunctivitis | Eye disorders | Placebo | 339 | 4,787 | |
| other | Abdominal pain upper | Gastrointestinal disorders | RotaTeq™ | 53 | 4,800 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 40 | 4,787 | |
| other | Constipation | Gastrointestinal disorders | RotaTeq™ | 188 | 4,800 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 214 | 4,787 | |
| other | Diarrhoea | Gastrointestinal disorders | RotaTeq™ | 1,047 | 4,800 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 1,022 | 4,787 | |
| other | Flatulence | Gastrointestinal disorders | RotaTeq™ | 273 | 4,800 | |
| other | Flatulence | Gastrointestinal disorders | Placebo | 282 | 4,787 |
1 to 10 of 758Source ClinicalTrials.gov
See all 758 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RotaTeq™ | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | RotaTeq™ | 4,000 | 4,800 |
| Total, other adverse events | Placebo | 4,047 | 4,787 |
| Total, serious adverse events | RotaTeq™ | 863 | 34,904 |
| Total, serious adverse events | Placebo | 955 | 34,862 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| RotaTeq™ vs Placebo: Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination | Trial comparisons |
| RotaTeq™ vs Placebo: G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus | Trial comparisons |
| RotaTeq™ vs Placebo: Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo | Trial comparisons |
| RotaTeq™ vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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