Trial · NCT00363545
To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
NCT00363545, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants). Trials, record NCT00363545. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00363545
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)
- NCT number
- NCT00363545
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,274 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Rotavirus
- Interventions
- Lyophilized formulation of HRV vaccine, Liquid formulation of HRV vaccine
- First posted
- 2006-08-15
- Last updated
- 2018-06-08
- Results first posted
- 2017-02-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Seroconverted Subjects Against Human Rotavirus | At 1 to 2 months after the second vaccine dose (Months 3-4) | A seroconverted subject was defined as a vaccinated subject who had an anti-rotavirus IgA antibody concentration equal to or above (≥) 20 units per milliliter (U/mL) and who was initially (i.e. prior to the first dose of Rotarix™ vaccine) negative for rotavirus. |
| Secondary | Concentrations of Anti-rotavirus IgA Antibodies | At 1 to 2 months after the second vaccine dose (Months 3-4) | Anti-rotavirus IgA antibody concentrations assessed by using the Enzyme-Linked Immunosorbent Assay (ELISA) are presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL). |
| Secondary | Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies | At 1 to 2 months after the second vaccine dose (Months 3-4) | Vaccine take was defined as appearance of serum anti-rotavirus IgA antibodies in post-vaccination sera at a concentration of ≥ 20 U/mL and/or vaccine virus excretion in any stool sample collected from Day 0 to Month 4, for subjects initially negative for rotavirus. The analysis was performed on the stool analysis subset, which included 100 subjects per group. |
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months. | Assessed solicited general symptoms were cough/runny nose, diarrhea, fever \[defined as rectal temperature equal to or above 38 degrees Celsius (°C)\], irritability/fussiness (Irr./Fuss.), loss of appetite and vomiting. Any = occurrence of the symptom regardless of intensity grade. Grade 3 cough/runny nose = cough/runny nose that prevented normal activity. Grade 3 diarrhea = 6 or more than (≥) 6 looser than normal stools/day. Grade 3 irritability/fussiness (Irr./Fuss.) = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 vomiting = 3 or more than (≥) 3 episodes of vomiting/day. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | Throughout the entire study period (from Day 0 to Month 4) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Secondary | Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes | From the first vaccine dose (Dose 1) up to Month 4 | The number of subjects with rotavirus (vaccine strain or wild-type rotavirus) in stool samples collected during gastroenteritis episodes from the first dose (Dose 1) of Rotarix™ vaccine up to Visit 3, as follows: between Dose 1 and before Dose 2, between Dose 2 and Visit 3 and between Dose 1 and Visit 3. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Seroconverted Subjects Against Human Rotavirus | At 1 to 2 months after the second vaccine dose (Months 3-4) | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point. | Subjects | NUMBER |
| SECONDARY | Concentrations of Anti-rotavirus IgA Antibodies | At 1 to 2 months after the second vaccine dose (Months 3-4) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at post-sampling time point. | U/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies | At 1 to 2 months after the second vaccine dose (Months 3-4) | The analysis was performed on the ATP cohort for immunogenicity stool analysis subset, defined as the first 200 subjects for whom pre-vaccination stool samples were available and with available anti-rotavirus IgA antibody results at post sampling time point or with vaccine virus in stools collected after the first vaccine dose up to Month 4. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses, up to 4 months. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Unsolicited Adverse Events (AEs) | Within 31 days after any vaccine dose (Day 0-30) post-vaccination, up to 4 months | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Serious Adverse Events (SAEs) | Throughout the entire study period (from Day 0 to Month 4) | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes | From the first vaccine dose (Dose 1) up to Month 4 | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one study vaccine administration documented and with symptoms sheet filled in. | Subjects | NUMBER |
Source ClinicalTrials.gov
Results by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Seroconverted Subjects Against Human Rotavirus | Liquid Rotarix Group | 363 | Subjects | ||
| Number of Seroconverted Subjects Against Human Rotavirus | Lyophilized Rotarix Group | 319 | Subjects | ||
| Concentrations of Anti-rotavirus IgA Antibodies | Liquid Rotarix Group | 151.2 | 95% Confidence Interval 128.0 to 178.7 | U/mL | |
| Concentrations of Anti-rotavirus IgA Antibodies | Lyophilized Rotarix Group | 111.7 | 95% Confidence Interval 93.5 to 133.4 | U/mL | |
| Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies | Liquid Rotarix Group | 67 | Subjects | ||
| Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies | Lyophilized Rotarix Group | 51 | Subjects | ||
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Liquid Rotarix Group | Any Cough/runny nose, Dose 1 | 234 | Subjects | |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Lyophilized Rotarix Group | Any Cough/runny nose, Dose 1 | 252 | Subjects | |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Liquid Rotarix Group | Grade 3 Cough/runny nose, Dose 1 | 22 | Subjects | |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Lyophilized Rotarix Group | Grade 3 Cough/runny nose, Dose 1 | 20 | Subjects |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Liquid Rotarix Group | 636 | |
| Overall Study | STARTED | Lyophilized Rotarix Group | 638 | |
| Overall Study | COMPLETED | Liquid Rotarix Group | 592 | |
| Overall Study | COMPLETED | Lyophilized Rotarix Group | 581 | |
| Overall Study | NOT COMPLETED | Liquid Rotarix Group | 44 | |
| Overall Study | NOT COMPLETED | Lyophilized Rotarix Group | 57 |
Source ClinicalTrials.gov
Adverse events60
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 | Cough/runny nose | General disorders | Liquid Rotarix Group | 335 | 636 | |
| other | Cough/runny nose | General disorders | Lyophilized Rotarix Group | 342 | 638 | |
| other | Diarrhea | General disorders | Liquid Rotarix Group | 61 | 636 | |
| other | Diarrhea | General disorders | Lyophilized Rotarix Group | 59 | 638 | |
| other | Fever (Rectal) | General disorders | Liquid Rotarix Group | 405 | 636 | |
| other | Fever (Rectal) | General disorders | Lyophilized Rotarix Group | 406 | 638 | |
| other | Irritability/ Fussiness | General disorders | Liquid Rotarix Group | 401 | 636 | |
| other | Irritability/ Fussiness | General disorders | Lyophilized Rotarix Group | 427 | 638 | |
| other | Loss of appetite | General disorders | Liquid Rotarix Group | 218 | 636 | |
| other | Loss of appetite | General disorders | Lyophilized Rotarix Group | 234 | 638 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Liquid Rotarix Group | ||
| Total, all-cause mortality | Lyophilized Rotarix Group | ||
| Total, other adverse events | Liquid Rotarix Group | 553 | 636 |
| Total, other adverse events | Lyophilized Rotarix Group | 556 | 638 |
| Total, serious adverse events | Liquid Rotarix Group | 37 | 636 |
| Total, serious adverse events | Lyophilized Rotarix Group | 38 | 638 |
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 |
|---|
| Liquid Rotarix Group vs Lyophilized Rotarix 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/NCT00363545
GET https://conductscience.org/api/trials/v1/NCT00363545/results?page=2