Trial · NCT03954743
Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
NCT03954743, Phase 3, Completed, GlaxoSmithKline; results first posted 2021-06-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks. Trials, record NCT03954743. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03954743
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
- NCT number
- NCT03954743
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,351 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Rotavirus
- Interventions
- PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine, Lyophilized formulation of GSK's oral live attenuated HRV vaccine
- First posted
- 2019-05-17
- Last updated
- 2022-03-10
- Other registries' IDs
- eudract:2018-001986-18
- Results first posted
- 2021-06-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination | During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1) | Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination. |
| Primary | Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination | During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2) | Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination. |
| Primary | Number of Subjects With Any Unsolicited AEs | During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2) | An unsolicited AE is defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of AE regardless of intensity grade or relation to study vaccination. |
| Primary | Number of Subjects With Any Serious Adverse Events (SAEs) | Throughout the study period (from Day 1 up to Month 7 or Month 8) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination. |
Source ClinicalTrials.gov
Outcomes4
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 Solicited General Adverse Events (AEs) After the First Vaccination | During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1) | Analysis was performed on the Exposed set (ES), which included all subjects with at least one study vaccine administration documented and with the diary card completed after the first vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination | During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2) | Analysis was performed on the Exposed set (ES), which included all subjects with at least one study vaccine administration documented and with the diary card completed after the second vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Any Unsolicited AEs | During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2) | Analysis was performed on the Exposed set (ES), which included all subjects with at least one study vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Any Serious Adverse Events (SAEs) | Throughout the study period (from Day 1 up to Month 7 or Month 8) | Analysis was performed on the Exposed set (ES), which included all subjects with at least one study vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
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 Solicited General Adverse Events (AEs) After the First Vaccination | HRV PCV-free Liq Group | Cough / Runny Nose, Any | 139 | Participants | |
| Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination | HRV Lyo Group | Cough / Runny Nose, Any | 166 | Participants | |
| Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination | HRV PCV-free Liq Group | Diarrhea, Any | 41 | Participants | |
| Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination | HRV Lyo Group | Diarrhea, Any | 47 | Participants | |
| Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination | HRV PCV-free Liq Group | Fever, ≥ 38.0°C | 27 | Participants | |
| Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination | HRV Lyo Group | Fever, ≥ 38.0°C | 21 | Participants | |
| Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination | HRV PCV-free Liq Group | Irritability / Fussiness, Any | 431 | Participants | |
| Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination | HRV Lyo Group | Irritability / Fussiness, Any | 428 | Participants | |
| Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination | HRV PCV-free Liq Group | Loss of appetite, Any | 201 | Participants | |
| Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination | HRV Lyo Group | Loss of appetite, Any | 186 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HRV PCV-free Liq Group | 677 | |
| Overall Study | STARTED | HRV Lyo Group | 674 | |
| Overall Study | COMPLETED | HRV PCV-free Liq Group | 653 | |
| Overall Study | COMPLETED | HRV Lyo Group | 657 | |
| Overall Study | NOT COMPLETED | HRV PCV-free Liq Group | 24 | |
| Overall Study | NOT COMPLETED | HRV Lyo Group | 17 |
Source ClinicalTrials.gov
Adverse events322
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 | Ankyloglossia congenital | Congenital, familial and genetic disorders | HRV PCV-free Liq Group | 2 | 677 | 2 |
| other | Ankyloglossia congenital | Congenital, familial and genetic disorders | HRV Lyo Group | 1 | 674 | 1 |
| other | Buried penis syndrome | Congenital, familial and genetic disorders | HRV PCV-free Liq Group | 0 | 677 | 0 |
| other | Buried penis syndrome | Congenital, familial and genetic disorders | HRV Lyo Group | 1 | 674 | 1 |
| other | Developmental hip dysplasia | Congenital, familial and genetic disorders | HRV PCV-free Liq Group | 1 | 677 | 1 |
| other | Developmental hip dysplasia | Congenital, familial and genetic disorders | HRV Lyo Group | 0 | 674 | 0 |
| other | Hydrocele | Congenital, familial and genetic disorders | HRV PCV-free Liq Group | 0 | 677 | 0 |
| other | Hydrocele | Congenital, familial and genetic disorders | HRV Lyo Group | 1 | 674 | 1 |
| other | Ear pain | Ear and labyrinth disorders | HRV PCV-free Liq Group | 1 | 677 | 1 |
| other | Ear pain | Ear and labyrinth disorders | HRV Lyo Group | 1 | 674 | 1 |
1 to 10 of 322Source ClinicalTrials.gov
See all 322 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HRV PCV-free Liq Group | 0 | 677 |
| Total, all-cause mortality | HRV Lyo Group | 0 | 674 |
| Total, other adverse events | HRV PCV-free Liq Group | 591 | 677 |
| Total, other adverse events | HRV Lyo Group | 571 | 674 |
| Total, serious adverse events | HRV PCV-free Liq Group | 39 | 677 |
| Total, serious adverse events | HRV Lyo Group | 38 | 674 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HRV PCV-free Liq Group vs HRV Lyo Group: Number of Subjects With Any Unsolicited AEs | Trial comparisons |
| HRV PCV-free Liq Group vs HRV Lyo Group: Number of Subjects With Any Serious Adverse Events (SAEs) | Trial comparisons |
| HRV PCV-free Liq Group vs HRV Lyo Group: deaths from any cause | Trial comparisons |
| HRV PCV-free Liq Group vs HRV Lyo 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/NCT03954743
GET https://conductscience.org/api/trials/v1/NCT03954743/results?page=2