Trial · NCT00092443
Dose Confirmation Efficacy Study (V260-007)
NCT00092443, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose Confirmation Efficacy Study (V260-007). Trials, record NCT00092443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00092443
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Confirmation Efficacy Study (V260-007)
- NCT number
- NCT00092443
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,312 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Rotavirus Infections
- Interventions
- RotaTeq™, rotavirus vaccine, live, oral, pentavalent, Comparator: Placebo matching RotaTeq™
- First posted
- 2004-09-27
- Last updated
- 2015-09-14
- Results first posted
- 2009-07-10
- Limitations and caveats
- Safety has been reported in the literature.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. | At least 14 days following the 3rd vaccination | G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition |
| Secondary | Number of Subjects With ≥3 Fold Rise in Antibody Titer | 14 days following the 3rd vaccination | Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer) |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. | At least 14 days following the 3rd vaccination | Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen Enzyme immunoassay (EIA) prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. | Participants | NUMBER |
| SECONDARY | Number of Subjects With ≥3 Fold Rise in Antibody Titer | 14 days following the 3rd vaccination | Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen EIA prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. | RotaTeq™ at Expiry Potency (≈1.1 x 107 IU/Dose) | 15 | Participants | ||
| Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. | Placebo Matching RotaTeq™ | 54 | Participants | ||
| Number of Subjects With ≥3 Fold Rise in Antibody Titer | RotaTeq™ at Expiry Potency (SNA - G1) | 38 | Participants | ||
| Number of Subjects With ≥3 Fold Rise in Antibody Titer | RotaTeq™ at Expiry Potency (SNA - G2) | 9 | Participants | ||
| Number of Subjects With ≥3 Fold Rise in Antibody Titer | RotaTeq™ at Expiry Potency (SNA - G3) | 6 | Participants | ||
| Number of Subjects With ≥3 Fold Rise in Antibody Titer | RotaTeq™ at Expiry Potency (SNA - G4) | 25 | Participants | ||
| Number of Subjects With ≥3 Fold Rise in Antibody Titer | RotaTeq™ at Expiry Potency (SNA - P1A) | 15 | Participants | ||
| Number of Subjects With ≥3 Fold Rise in Antibody Titer | Placebo Matching RotaTeq™ (SNA - G1) | 2 | Participants | ||
| Number of Subjects With ≥3 Fold Rise in Antibody Titer | Placebo Matching RotaTeq™ (SNA - G2) | 0 | Participants | ||
| Number of Subjects With ≥3 Fold Rise in Antibody Titer | Placebo Matching RotaTeq™ (SNA - G3) | 0 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 651 | |
| Overall Study | STARTED | Placebo Matching RotaTeq™ | 661 | |
| Overall Study | Vaccinated at Visit 1 | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 650 | |
| Overall Study | Vaccinated at Visit 1 | Placebo Matching RotaTeq™ | 660 | |
| Overall Study | Vaccinated at Visit 2 | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 618 | |
| Overall Study | Vaccinated at Visit 2 | Placebo Matching RotaTeq™ | 627 | |
| Overall Study | Vaccinated at Visit 3 | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 593 | |
| Overall Study | Vaccinated at Visit 3 | Placebo Matching RotaTeq™ | 608 | |
| Overall Study | COMPLETED | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 593 | |
| Overall Study | COMPLETED | Placebo Matching RotaTeq™ | 607 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events100
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™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 50 | 649 | 56 |
| other | Conjunctivitis | Eye disorders | Placebo Matching RotaTeq™ | 46 | 658 | 53 |
| other | Constipation | Gastrointestinal disorders | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 35 | 649 | 39 |
| other | Constipation | Gastrointestinal disorders | Placebo Matching RotaTeq™ | 34 | 658 | 38 |
| other | Diarrhoea | Gastrointestinal disorders | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 103 | 649 | 160 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Matching RotaTeq™ | 110 | 658 | 177 |
| other | Flatulence | Gastrointestinal disorders | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 52 | 649 | 72 |
| other | Flatulence | Gastrointestinal disorders | Placebo Matching RotaTeq™ | 49 | 658 | 78 |
| other | Regurgitation of food | Gastrointestinal disorders | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 44 | 649 | 54 |
| other | Regurgitation of food | Gastrointestinal disorders | Placebo Matching RotaTeq™ | 41 | 658 | 55 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | ||
| Total, all-cause mortality | Placebo Matching RotaTeq™ | ||
| Total, other adverse events | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 558 | 649 |
| Total, other adverse events | Placebo Matching RotaTeq™ | 565 | 658 |
| Total, serious adverse events | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | 21 | 649 |
| Total, serious adverse events | Placebo Matching RotaTeq™ | 28 | 658 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17200266 | BACKGROUND |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
RotaTeq™ at Expiry Potency (≈1.1 x 107 IU/Dose) vs Placebo Matching RotaTeq™: Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. | Trial comparisons |
| RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) vs Placebo Matching RotaTeq™: 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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00092443
GET https://conductscience.org/api/trials/v1/NCT00092443/events?page=2