Trial · NCT02062385
Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
NCT02062385, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2016-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024). Trials, record NCT02062385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02062385
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
- NCT number
- NCT02062385
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,040 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Rotavirus Gastroenteritis
- Interventions
- V260, Placebo to V260, OPV, DTaP
- First posted
- 2014-02-13
- Last updated
- 2018-11-27
- Results first posted
- 2016-04-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Severity of Rotavirus Gastroenteritis | From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months) | The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms. |
| Secondary | Percentage of Participants With Elevated Temperature | Up to 30 days after any dose of V260 or Placebo | Elevated temperature (temperature \>=37.5°C axillary or equivalent) was noted by the guardian and recorded on the Vaccination Report Card during Day 1 to Day 14 after each dose of vaccination. Elevated temperature reported by the guardian was also collected as an adverse event (pyrexia) during Day 15 to Day 30 after each dose of vaccination. The percentage of participants with axillary temperature \>=37.5 °C or an adverse event of pyrexia was assessed. |
| Secondary | Percentage of Participants With Vomiting or Diarrhea | Up to 30 days after any dose of V260 or Placebo | Episodes of vomiting and diarrhea were noted by the guardian and recorded on the Vaccination Record Card during Day 1 to Day 14 after each dose of vaccination. Vomiting and diarrhea reported by the guardian were also collected as an adverse event during Day 15 to Day 30 after any dose of vaccination. The percentage of participants with an episode or an adverse event of vomiting or diarrhea was assessed. |
| Secondary | Percentage of Participants With Intussusception | Up to 15 months | Episodes of intussusception were collected from the time of written consent until the end of study. The percentage of participants with an episode of intussusception was assessed. |
| Secondary | Number of Participants With Severe Rotavirus Gastroenteritis | From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months) | The number of participants with severe rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms. Severe RVGE was defined as \>=11 on the Vesikari Scoring System, a composite of the seven parameters related to symptoms and treatment with an overall range from 0 to 20. |
| Secondary | Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3 | Baseline and between 28 and 56 days after the third OPV vaccination | The percentage of participants who achieved seroprotection against poliovirus Type 1, 2, or 3 was assessed. Seroprotection was defined as a neutralizing antibody titer \>=1:8. This outcome was evaluated only in participants receiving concomitant administration of V260 and OPV. |
| Secondary | Percentage of Participants With Any Adverse Event | Up to 30 days after any dose of V260 or Placebo | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the sponsor's product, is also an adverse event. |
| Secondary | Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens | Baseline and between 28 and 51 days after the third DTaP vaccination | The percentage of participants seropositive to diphtheria, pertussis, or tetanus antigens was assessed. Seropositive was defined as the following: 1) anti-diphtheria antibody titers \>=0.1 International Units (IU)/mL, 2) anti-tetanus antibody titers \>=0.1 IU/mL, 3) antipertussis toxin antibody titers \>=20 Enzyme-linked Immunosorbent Assay (ELISA) Units (EU)/mL, 4) anti-pertussis filamentous hemagglutinin (FHA) antibody titers \>=20 EU/mL. This outcome was evaluated only in participants receiving concomitant administration of V260 and EPI. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Severity of Rotavirus Gastroenteritis | From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months) | Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Elevated Temperature | Up to 30 days after any dose of V260 or Placebo | All Subjects as Treated with follow-up specific to the endpoint | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Vomiting or Diarrhea | Up to 30 days after any dose of V260 or Placebo | All Subjects as Treated with safety follow-up | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Intussusception | Up to 15 months | All Subjects as Treated with safety follow-up | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Severe Rotavirus Gastroenteritis | From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months) | Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition. | Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3 | Baseline and between 28 and 56 days after the third OPV vaccination | Participants in the concomitant EPI groups who receive their scheduled doses of OPV without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Any Adverse Event | Up to 30 days after any dose of V260 or Placebo | All Subjects as Treated with safety follow-up | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens | Baseline and between 28 and 51 days after the third DTaP vaccination | Participants in the concomitant EPI groups who receive their scheduled doses of DTaP without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Severity of Rotavirus Gastroenteritis | V260 With Staggered or Concomitant EPI | 34 | Participants | ||
| Number of Participants With Any Severity of Rotavirus Gastroenteritis | Placebo With Staggered or Concomitant EPI | 109 | Participants | ||
| Percentage of Participants With Elevated Temperature | V260 With Staggered or Concomitant EPI | 21.84 | Percentage of participants | ||
| Percentage of Participants With Elevated Temperature | Placebo With Staggered or Concomitant EPI | 22.83 | Percentage of participants | ||
| Percentage of Participants With Vomiting or Diarrhea | V260 With Staggered or Concomitant EPI | Vomiting | 2.68 | Percentage of participants | |
| Percentage of Participants With Vomiting or Diarrhea | Placebo With Staggered or Concomitant EPI | Vomiting | 3.52 | Percentage of participants | |
| Percentage of Participants With Vomiting or Diarrhea | V260 With Staggered or Concomitant EPI | Diarrhea | 20.15 | Percentage of participants | |
| Percentage of Participants With Vomiting or Diarrhea | Placebo With Staggered or Concomitant EPI | Diarrhea | 20.11 | Percentage of participants | |
| Percentage of Participants With Intussusception | V260 With Staggered or Concomitant EPI | 0.10 | Percentage of participants | ||
| Percentage of Participants With Intussusception | Placebo With Staggered or Concomitant EPI | 0.00 | Percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | V260 With Staggered EPI | 1,620 | |
| Overall Study | STARTED | Placebo With Staggered EPI | 1,620 | |
| Overall Study | STARTED | V260 With Concomitant EPI | 400 | |
| Overall Study | STARTED | Placebo With Concomitant EPI | 400 | |
| Overall Study | Received Vaccination 1 | V260 With Staggered EPI | 1,618 | |
| Overall Study | Received Vaccination 1 | Placebo With Staggered EPI | 1,619 | |
| Overall Study | Received Vaccination 1 | V260 With Concomitant EPI | 400 | |
| Overall Study | Received Vaccination 1 | Placebo With Concomitant EPI | 400 | |
| Overall Study | Received Vaccination 2 | V260 With Staggered EPI | 1,554 | |
| Overall Study | Received Vaccination 2 | Placebo With Staggered EPI | 1,566 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events142
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 | Diarrhoea | Gastrointestinal disorders | V260 With Staggered or Concomitant EPI | 406 | 2,015 | 487 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo With Staggered or Concomitant EPI | 406 | 2,019 | 504 |
| other | Pyrexia | General disorders | V260 With Staggered or Concomitant EPI | 414 | 2,015 | 492 |
| other | Pyrexia | General disorders | Placebo With Staggered or Concomitant EPI | 419 | 2,019 | 481 |
| other | Nasopharyngitis | Infections and infestations | V260 With Staggered or Concomitant EPI | 228 | 2,015 | 248 |
| other | Nasopharyngitis | Infections and infestations | Placebo With Staggered or Concomitant EPI | 233 | 2,019 | 268 |
| other | Upper respiratory tract infection | Infections and infestations | V260 With Staggered or Concomitant EPI | 91 | 2,015 | 98 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo With Staggered or Concomitant EPI | 103 | 2,019 | 114 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | V260 With Staggered or Concomitant EPI | 115 | 2,015 | 133 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo With Staggered or Concomitant EPI | 92 | 2,019 | 109 |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | V260 With Staggered or Concomitant EPI | ||
| Total, all-cause mortality | Placebo With Staggered or Concomitant EPI | ||
| Total, other adverse events | V260 With Staggered or Concomitant EPI | 938 | 2,015 |
| Total, other adverse events | Placebo With Staggered or Concomitant EPI | 931 | 2,019 |
| Total, serious adverse events | V260 With Staggered or Concomitant EPI | 339 | 2,015 |
| Total, serious adverse events | Placebo With Staggered or Concomitant EPI | 338 | 2,019 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| V260 With Staggered or Concomitant EPI vs Placebo With Staggered or Concomitant EPI: Number of Participants With Severe Rotavirus Gastroenteritis | Trial comparisons |
| V260 With Staggered or Concomitant EPI vs Placebo With Staggered or Concomitant EPI: Number of Participants With Any Severity of Rotavirus Gastroenteritis | Trial comparisons |
| V260 With Staggered or Concomitant EPI vs Placebo With Staggered or Concomitant EPI: 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/NCT02062385
GET https://conductscience.org/api/trials/v1/NCT02062385/results?page=2