Trial · NCT01171963
Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
NCT01171963, Phase 3, Completed, GlaxoSmithKline; results first posted 2013-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants. Trials, record NCT01171963. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01171963
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants
- NCT number
- NCT01171963
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,340 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Rotavirus
- Interventions
- GSK Biologicals' liquid human rotavirus vaccine 444563, Placebo, Infanrix™, Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)
- First posted
- 2010-07-29
- Last updated
- 2018-08-06
- Results first posted
- 2013-06-24
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RV GE with score equal to or higher than (\>=) 11 on a 20-point Vesikari scoring system. |
| 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 | A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. |
| Secondary | Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | From Month 1 ½ to Month 21 | A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT. |
| Secondary | Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | From Month 1 ½ to Month 21 | A gastroenteritis episode was classified positive for rotavirus (RV) if RV was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RVGE with score equal to or higher than (\>=) 11 on a 20-point Vesikari scoring system. RV types assessed were G1 Wild Type (G1WT), G2, G3, G9, GX (G type unknown, but not vaccine strain), P4, P8 Wild Type (P8WT), P9, PX (P type unknown, but not vaccine strain) and Pooled Non-G1WT. |
| 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 | A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating WT RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. |
| Secondary | Number of Subjects With Any and Severe Gastroenteritis (GE) Due to Any Cause | From Month 1 ½ to Month 21 | Severe GE was defined as an episode of GE with score equal to or higher than (\>=) 11 on a 20-point Vesikari scoring system. This outcome measure concerns results for GE episodes due to any cause. |
| 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 | Assessed solicited general symptoms were fever,defined as axillary temperature (T) above or equal to \[\>=\] 37.5 degrees Celsius \[°C\] (if GSK scale) or \>= 37.1°C (if Chinese scale), fussiness/irritability, loss of appetite, cough/runny nose, diarrhea and vomiting. Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 1, who received the EPI vaccination independently of study vaccination with the Rotarix vaccine/placebo. |
| 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 | Solicited general symptoms assessed following administration of the co-administered EPI vaccines were drowsiness, gastrointestinal symptoms, fussiness/irritability, loss of appetite, and fever, defined as axillary temperature (T) above or equal to \[\>=\] 37.5 degrees Celsius \[°C\] (if GSK scale) or \>= 37.1°C (if Chinese scale ). Any = any occurrence of the specified solicited general symptom regardless of the intensity grade or relationship to vaccination. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo. |
| 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 | Solicited local symptoms assessed following administration of the co-administered EPI vaccines were pain, swelling, and redness. Any = any occurrence of the specified solicited local symptom regardless of the intensity grade. This outcome measure was only assessed in subjects from Sub-cohort 2, who received the EPI vaccination concomitantly with study vaccination with the Rotarix vaccine/placebo. |
| 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 | An unsolicited AE is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of the intensity grade or relationship to vaccination. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes26
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 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 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group196
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 Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains | Rotarix Group | 21 | Participants | ||
| Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains | Placebo Group | 75 | Participants | ||
| Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains | Rotarix Group | 70 | Participants | ||
| Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains | Placebo Group | 167 | Participants | ||
| Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | Rotarix Group | Subjects with G1WT RVGE | 22 | Participants | |
| Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | Placebo Group | Subjects with G1WT RVGE | 46 | Participants | |
| Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | Rotarix Group | Subjects with G2 RVGE | 42 | Participants | |
| Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | Placebo Group | Subjects with G2 RVGE | 105 | Participants | |
| Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | Rotarix Group | Subjects with G3 RVGE | 1 | Participants | |
| Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) of Any Type. | Placebo Group | Subjects with G3 RVGE | 12 | Participants |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 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 | 1,666 | |
| Overall Study | STARTED | Placebo Group | 1,667 | |
| Overall Study | COMPLETED | Rotarix Group | 1,518 | |
| Overall Study | COMPLETED | Placebo Group | 1,499 | |
| Overall Study | NOT COMPLETED | Rotarix Group | 148 | |
| Overall Study | NOT COMPLETED | Placebo Group | 168 |
Source ClinicalTrials.gov
Adverse events196
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 | Upper respiratory tract infection | Infections and infestations | Rotarix Group | 119 | 1,666 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo Group | 124 | 1,667 | |
| other | Nasopharyngitis | Infections and infestations | Rotarix Group | 103 | 1,666 | |
| other | Nasopharyngitis | Infections and infestations | Placebo Group | 123 | 1,667 | |
| other | Cough/runny nose | General disorders | Rotarix Group | 313 | 1,513 | |
| other | Cough/runny nose | General disorders | Placebo Group | 366 | 1,514 | |
| other | Diarrhoea | General disorders | Rotarix Group | 127 | 1,513 | |
| other | Diarrhoea | General disorders | Placebo Group | 123 | 1,514 | |
| other | Irritability/Fussiness | General disorders | Rotarix Group | 415 | 1,513 | |
| other | Irritability/Fussiness | General disorders | Placebo Group | 448 | 1,514 |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 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 | 838 | 1,666 |
| Total, other adverse events | Placebo Group | 880 | 1,667 |
| Total, serious adverse events | Rotarix Group | 183 | 1,666 |
| Total, serious adverse events | Placebo Group | 246 | 1,667 |
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rotarix Group vs Placebo Group: Number of Subjects With Any Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild-type Strains | Trial comparisons |
| Rotarix Group vs Placebo Group: Number of Subjects With Episodes of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains Requiring Hospitalization | Trial comparisons |
| Rotarix Group vs Placebo Group: Number of Subjects With Any Unsolicited Adverse Events (AEs) | Trial comparisons |
| Rotarix Group vs Placebo Group: Number of Subjects With Any Serious Adverse Events (SAEs) | Trial comparisons |
| Rotarix Group vs Placebo Group: Number of Subjects With Severe Episode(s) of Rotavirus Gastroenteritis (RVGE) Caused by the Circulating Wild Type (WT) Strains | Trial comparisons |
| Rotarix Group vs Placebo Group: 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/NCT01171963
GET https://conductscience.org/api/trials/v1/NCT01171963/registered?page=2