Trial · NCT01171963
Outcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains | From Month 1 ½ to Month 21 | The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains | From Month 1 ½ to Month 21 | The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | From Month 1 ½ to Month 21 | The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | From Month 1 ½ to Month 21 | The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Episodes of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains Requiring Hospitalization | From Month 1 ½ to Month 21 | The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause | From Month 1 ½ to Month 21 | The analysis was performed on the According-to-Protocol cohort for efficacy, which included subjects vaccinated with Rotarix™ vaccine or placebo who had entered the efficacy surveillance period (Months 1 ½-21) with no rotavirus other than vaccine strain in the gastroenteritis stool samples collected between Day 0 and Month 1 ½. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Solicited General Symptoms Following Vaccination With the Rotarix Vaccine/Placebo | Within the 8-day (Days 0-7) follow-up periods after any dose of Rotarix vaccine/placebo | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Solicited General Symptoms Following Administration of the Co-administered EPI Vaccines | Within the 8-day (Days 0-7) follow-up periods following Doses 1 and 2 of the OPV vaccine and Dose 1 of the Infanrix vaccine | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Solicited Local Symptoms Following Dose 2 of the Rotarix Vaccine/Placebo | Within the 8-day (Days 0-7) follow-up periods following Dose 2 of the Rotarix vaccine/placebo | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within the 31-day (Days 0-30) follow-up periods following any dose of the Rotarix vaccine or placebo | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Serious Adverse Events (SAEs) | Throughout the entire study period (from Day 0 to Study End at Month 21) | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies | At Month 2 and at 12 months of age | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. | At Month 2 and at 12 months of age | Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. | At Month 2 and at 12 months of age | Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. | At Day 0, Month 2 and at 12 months of age | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. | At Day 0, Month 2 and at 12 months of age | Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Seropositive for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies. | At Day 0, Month 2 and at 12 months of age | Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations | At Day 0, Month 2 and at 12 months of age | Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity Sub-cohort 1, which included subjects vaccinated with at least 1 dose of HRV vaccine/Placebo, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point. | U/mL | GEOMETRIC_MEAN |
| SECONDARY | Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations. | At Day 0, Month 2 and at 12 months of age. | Analysis was performed on the ATP cohort for immunogenicity Sub-cohort 2, which included subjects with OPV and Infanrix™ vaccines co-administered with the study vaccine, complying with protocol, with EPI childhood vaccinations completed according to Chinese recommendations and available immunogenicity data at post sampling time-point. | U/mL | GEOMETRIC_MEAN |
| SECONDARY | Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations. | At Day 0, Month 2 and at 12 months of age | Analysis was performed on the ATP cohort for immunogenicity, which included eligible subjects in the ATP cohorts for immunogenicity sub-cohorts 1 and 2 seronegative for serum anti-rotavirus immunoglobulin A (IgA) antibodies at Day 0 and with availability immunogenicity data at pre and post sampling time-points. | U/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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GET https://conductscience.org/api/trials/v1/NCT01171963/outcomes