Trial · NCT00420316
Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
NCT00420316, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine. Trials, record NCT00420316. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00420316
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
- NCT number
- NCT00420316
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,613 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Rotavirus
- Interventions
- Rotarix (primary vaccination study), Placebo (primary vaccination study)
- First posted
- 2007-01-11
- Last updated
- 2018-08-28
- Results first posted
- 2017-02-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) | During the study period for the long-term follow-up (i.e. 6 months) | Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. |
| Secondary | Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) | During the study period for the long-term follow-up (i.e. 6 months) | Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe. |
| Secondary | Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype | During the study period for the long-term follow-up (i.e. 6 months) | Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. Only GE episodes in which wild-type RV strain of G1 serotype was identified in a stool specimen, were included in the efficacy analysis. |
| Secondary | Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype | During the study period for the long-term follow-up (i.e. 6 months) | Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of serotype G1 and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe. |
| Secondary | Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype | During the study period for the long-term follow-up (i.e. 6 months) | Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain of non-G1 serotype was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. |
| Secondary | Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype | During the study period for the long-term follow-up (i.e. 6 months) | Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of non-G1 serotype and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe. |
| Secondary | Number of Subjects With Severe Gastroenteritis (GE) | During the study period for the long-term follow-up (i.e. 6 months) | Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility. |
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | During the study period for the long-term follow-up (i.e. 6 months) | An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. |
| Secondary | Number of Subjects Reporting Intussusception (IS) | During the period starting from the end of the second follow-up up to the start of the study (up to 6 months) | Intussusception is defined as the telescoping of the intestine. |
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 | Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) | During the study period for the long-term follow-up (i.e. 6 months) | The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) | During the study period for the long-term follow-up (i.e. 6 months) | The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype | During the study period for the long-term follow-up (i.e. 6 months) | The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype | During the study period for the long-term follow-up (i.e. 6 months) | The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype | During the study period for the long-term follow-up (i.e. 6 months) | The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype | During the study period for the long-term follow-up (i.e. 6 months) | The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Severe Gastroenteritis (GE) | During the study period for the long-term follow-up (i.e. 6 months) | The analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, which included all subjects from the ATP efficacy cohort of the primary study (102247) who entered into the efficacy surveillance period. | Subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Serious Adverse Events (SAEs) | During the study period for the long-term follow-up (i.e. 6 months) | The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study. | Subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Intussusception (IS) | During the period starting from the end of the second follow-up up to the start of the study (up to 6 months) | The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study. | Subjects | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) | Rotarix Group | 4 | Subjects | ||
| Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) | Placebo Group | 3 | Subjects | ||
| Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) | Rotarix Group | 1 | Subjects | ||
| Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) | Placebo Group | 1 | Subjects | ||
| Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype | Rotarix Group | 0 | Subjects | ||
| Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype | Placebo Group | 2 | Subjects | ||
| Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype | Rotarix Group | 0 | Subjects | ||
| Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype | Placebo Group | 1 | Subjects | ||
| Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype | Rotarix Group | 4 | Subjects | ||
| Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype | Placebo Group | 1 | Subjects |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rotarix Group | 1,082 | |
| Overall Study | STARTED | Placebo Group | 531 | |
| Overall Study | COMPLETED | Rotarix Group | 1,070 | |
| Overall Study | COMPLETED | Placebo Group | 522 | |
| Overall Study | NOT COMPLETED | Rotarix Group | 12 | |
| Overall Study | NOT COMPLETED | Placebo Group | 9 |
Source ClinicalTrials.gov
Adverse events16
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 |
|---|---|---|---|---|---|---|
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Rotarix Group | 1 | 1,082 | |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Placebo Group | 1 | 531 | |
| serious | Febrile convulsion | Nervous system disorders | Rotarix Group | 0 | 1,082 | |
| serious | Febrile convulsion | Nervous system disorders | Placebo Group | 1 | 531 | |
| serious | Gastroenteritis | Infections and infestations | Rotarix Group | 1 | 1,082 | |
| serious | Gastroenteritis | Infections and infestations | Placebo Group | 1 | 531 | |
| serious | Pneumonia | Infections and infestations | Rotarix Group | 0 | 1,082 | |
| serious | Pneumonia | Infections and infestations | Placebo Group | 2 | 531 | |
| serious | Laryngitis | Infections and infestations | Rotarix Group | 1 | 1,082 | |
| serious | Laryngitis | Infections and infestations | Placebo Group | 0 | 531 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rotarix Group | ||
| Total, all-cause mortality | Placebo Group | ||
| Total, other adverse events | Rotarix Group | 0 | 1,082 |
| Total, other adverse events | Placebo Group | 0 | 531 |
| Total, serious adverse events | Rotarix Group | 4 | 1,082 |
| Total, serious adverse events | Placebo Group | 7 | 531 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Rotarix Group vs Placebo Group: serious adverse events |
Source 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/NCT00420316
GET https://conductscience.org/api/trials/v1/NCT00420316/registered