Trial · NCT05281094
Efficacy and Safety of Two Doses of HIL-214 in Children
NCT05281094, Phase 2, Phase 3, Terminated, HilleVax; results first posted 2025-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Two Doses of HIL-214 in Children. Trials, record NCT05281094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05281094
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Two Doses of HIL-214 in Children
- NCT number
- NCT05281094
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 3,084 participants, actual
- Lead sponsor
- HilleVax
- Conditions
- Gastroenteritis
- Interventions
- HIL-214, Placebo
- First posted
- 2022-03-16
- Last updated
- 2025-07-10
- Results first posted
- 2025-07-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes. | The duration of the primary observation period was 6 months starting at 28 days post dose 2. | Time to first occurrence during the primary observation period, of moderate/severe AGE case associated only with GI.1 or GII.4 norovirus genotypes. Vaccine efficacy (VE) is defined as 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The primary endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus-positive samples were genotyped by sequencing. Samples that were positive for GI.1 or GII.4 genotypes were further analyzed for the presence of co-pathogens. VE estimates and 95% confidence intervals (CIs) are also reported. |
| Secondary | To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With Any Norovirus (GI or GII) Genogroup. | The duration of the primary observation period was 6 months starting at 28 days post dose 2. | Time to first occurrence during the primary observation period, of moderate/severe AGE case associated with any (GI or GII) genogroup Vaccine efficacy (VE) is defined as 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus positive samples were genogrouped by sequencing. Samples that were positive for GI or GII genogroups were further analyzed for the presence of co-pathogens. Vaccine efficacy (VE) estimates and 95% confidence intervals (CIs) are also reported. |
| Secondary | To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With GI.1 or GII.4 Norovirus Genotypes, Irrespective of Other Gastrointestinal Pathogens. | The duration of the primary observation period was 6 months starting at 28 days post dose 2. | Time to first occurrence during the primary observation period\* of moderate/severe AGE case associated with GI.1 or GII.4 norovirus genotypes, irrespective of other gastrointestinal pathogens. Vaccine efficacy (VE) is defined as 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The primary endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus-positive samples were genotyped by sequencing. |
| Secondary | To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With Any Norovirus Genogroup (GI or GII), Irrespective of Other Gastrointestinal Pathogens | The duration of the primary observation period was 6 months starting at 28 days post dose 2. | Time to first occurrence during the primary observation period of moderate/severe AGE case associated with any norovirus genogroup (GI or GII), irrespective of other gastrointestinal pathogens. Vaccine efficacy (VE) is defined as 100% \[1- (λV/λC)\], where λV and λC denote the hazard rates of the primary endpoint AGE case for the HIL 214 and placebo arms, respectively. The endpoint AGE case is defined as at least 3 loose or liquid stools OR at least 2 or more episodes of vomiting OR 1 or more loose or liquid stools plus 1 or more vomiting episodes in any 24-hour period. The presence of norovirus in onset stool samples was assessed by RT-PCR and norovirus positive samples were genogrouped by sequencing. Vaccine efficacy (VE) estimates and 95% confidence intervals (CIs) are also reported. |
| Secondary | Immunogenicity of HIL-214 Compared to Placebo | Participant reaches 1 year of age | The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration) at up to 56 days post dose 1 (Visit 2), 28 days post dose 2 (Visit 3), and/or at 1 year of age (visit 4) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported. HBGA-blocking and pan-Ig assays were used for immunogenicity analyses |
| Secondary | Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events (AEs) | Up to 7 days after each dose of HIL-214 or placebo. | Percentage of participants with solicited local (injection site) adverse events (AEs) within 7 days of vaccine administration. Assessed AEs include injection site pain, erythema, induration, and swelling. |
| Secondary | Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs) | Up to 7 days after each dose of HIL-214 or placebo. | Percentage of participants with solicited systemic AEs within 7 days of vaccine administration. Assessed AEs include drowsiness, irritability/fussiness, loss of appetite, vomiting, and diarrhea. |
| Secondary | Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Vaccine Withdrawal | Up to 28 days after first dose of HIL-214 or placebo. | Percentage of participants with AEs leading to trial vaccine dose withdrawal. |
| Secondary | Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Trial Withdrawal. | From Day 1 to end of the trial/early termination. | Percentage of participants with AEs leading to trial withdrawal. |
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 | To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes. | The duration of the primary observation period was 6 months starting at 28 days post dose 2. | Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo. | months | MEAN |
| SECONDARY | To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With Any Norovirus (GI or GII) Genogroup. | The duration of the primary observation period was 6 months starting at 28 days post dose 2. | Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo. | months | MEAN |
| SECONDARY | To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With GI.1 or GII.4 Norovirus Genotypes, Irrespective of Other Gastrointestinal Pathogens. | The duration of the primary observation period was 6 months starting at 28 days post dose 2. | Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo. | months | MEAN |
| SECONDARY | To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With Any Norovirus Genogroup (GI or GII), Irrespective of Other Gastrointestinal Pathogens | The duration of the primary observation period was 6 months starting at 28 days post dose 2. | Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo. | months | MEAN |
| SECONDARY | Immunogenicity of HIL-214 Compared to Placebo | Participant reaches 1 year of age | Full-Analysis Set, The FAS will include all subjects who are randomized and received at least 1 dose of HIL-214 or placebo. | percentage of participants | NUMBER |
| SECONDARY | Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events (AEs) | Up to 7 days after each dose of HIL-214 or placebo. | Safety Analysis Set, all participants who were randomized and received at least 1 dose of trial vaccine (HIL-214 or placebo). | percentage of participants | NUMBER |
| SECONDARY | Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs) | Up to 7 days after each dose of HIL-214 or placebo. | Safety Analysis Set, all participants that received at least 1 dose of HIL-214 or placebo. | percentage of participants | NUMBER |
| SECONDARY | Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Vaccine Withdrawal | Up to 28 days after first dose of HIL-214 or placebo. | Safety Analysis Set; all participants that received at least 1 dose of HIL 214 or placebo. | percentage of participants | NUMBER |
| SECONDARY | Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Trial Withdrawal. | From Day 1 to end of the trial/early termination. | Safety Analysis Set; all participants that received at least 1 dose of HIL-214 or placebo. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes. | Placebo | 3.07 | Standard Deviation 2.059 | months | |
| To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes. | Experimental | 3.29 | Standard Deviation 1.746 | months | |
| To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With Any Norovirus (GI or GII) Genogroup. | Placebo | 3.16 | Standard Deviation 1.886 | months | |
| To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With Any Norovirus (GI or GII) Genogroup. | Experimental | 3.32 | Standard Deviation 1.519 | months | |
| To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With GI.1 or GII.4 Norovirus Genotypes, Irrespective of Other Gastrointestinal Pathogens. | Placebo | 3.11 | Standard Deviation 1.981 | months | |
| To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With GI.1 or GII.4 Norovirus Genotypes, Irrespective of Other Gastrointestinal Pathogens. | Experimental | 3.29 | Standard Deviation 1.628 | months | |
| To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With Any Norovirus Genogroup (GI or GII), Irrespective of Other Gastrointestinal Pathogens | Placebo | 3.19 | Standard Deviation 1.852 | months | |
| To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated With Any Norovirus Genogroup (GI or GII), Irrespective of Other Gastrointestinal Pathogens | Experimental | 3.17 | Standard Deviation 1.541 | months | |
| Immunogenicity of HIL-214 Compared to Placebo | Placebo | Anti-GI.1 HBGA-blocking seroresponse rate at Visit 2 | 0.6 | 95% Confidence Interval 0.3 to 1.2 | percentage of participants |
| Immunogenicity of HIL-214 Compared to Placebo | Experimental | Anti-GI.1 HBGA-blocking seroresponse rate at Visit 2 | 36.8 | 95% Confidence Interval 34.3 to 39.4 | percentage of participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 1,542 | |
| Overall Study | STARTED | Experimental | 1,542 | |
| Overall Study | Received Two Vaccinations | Placebo | 1,399 | |
| Overall Study | Received Two Vaccinations | Experimental | 1,425 | |
| Overall Study | COMPLETED | Placebo | 1,381 | |
| Overall Study | COMPLETED | Experimental | 1,410 | |
| Overall Study | NOT COMPLETED | Placebo | 161 | |
| Overall Study | NOT COMPLETED | Experimental | 132 |
Source ClinicalTrials.gov
Adverse events234
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 | Nasopharyngitis | Infections and infestations | Placebo | 474 | 1,536 | |
| other | Nasopharyngitis | Infections and infestations | Experimental | 492 | 1,541 | |
| other | Gastroenteritis | Infections and infestations | Placebo | 268 | 1,536 | |
| other | Gastroenteritis | Infections and infestations | Experimental | 285 | 1,541 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 75 | 1,536 | |
| other | Upper respiratory tract infection | Infections and infestations | Experimental | 69 | 1,541 | |
| other | Bronchiolitis | Infections and infestations | Placebo | 39 | 1,536 | |
| other | Bronchiolitis | Infections and infestations | Experimental | 47 | 1,541 | |
| other | Dermatitis diaper | Skin and subcutaneous tissue disorders | Placebo | 55 | 1,536 | |
| other | Dermatitis diaper | Skin and subcutaneous tissue disorders | Experimental | 64 | 1,541 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 1,536 |
| Total, all-cause mortality | Experimental | 2 | 1,541 |
| Total, other adverse events | Placebo | 889 | 1,536 |
| Total, other adverse events | Experimental | 902 | 1,541 |
| Total, serious adverse events | Placebo | 165 | 1,536 |
| Total, serious adverse events | Experimental | 169 | 1,541 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental vs Placebo: deaths from any cause | Trial comparisons |
| Experimental vs Placebo: 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/NCT05281094
GET https://conductscience.org/api/trials/v1/NCT05281094/results?page=2