Trial Outcomes & Findings for Efficacy and Safety of Two Doses of HIL-214 in Children (NCT NCT05281094)

Last Updated: 2025-07-10

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

3084 participants

Primary outcome timeframe

The duration of the primary observation period was 6 months starting at 28 days post dose 2.

Results posted on

2025-07-10

Participant Flow

Participants took part in the primary observation period of the trial (up to Visit 4) at 17 investigative sites in Panama, the Dominican Republic, Honduras, Peru, Columbia, Puerto Rico, and the United States from 28 April 2022 to 28 Dec 2023.

Participants were enrolled in 1 of 2 treatment arms and received 2 doses of either HIL-214, a norovirus vaccine comprising 50 µg GI.1 virus-like particle (VLP) and 150 µg GII.4c VLP, adjuvanted with 500 µg of aluminum hydroxide, or placebo.

Participant milestones

Participant milestones
Measure	Placebo One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.	Experimental One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.
Overall Study STARTED	1542	1542
Overall Study Received Two Vaccinations	1399	1425
Overall Study COMPLETED	1381	1410
Overall Study NOT COMPLETED	161	132

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.	Experimental One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	29	22
Overall Study Withdrawal by Legally Authorized Representative	122	103
Overall Study Death	1	2
Overall Study Not pre-specified reason	8	5

Baseline Characteristics

Weight not reported for all participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=1399 Participants One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.	Experimental n=1425 Participants One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.	Total n=2824 Participants Total of all reporting groups
Age, Continuous	4.94 months STANDARD_DEVIATION 0.295 • n=1399 Participants	4.95 months STANDARD_DEVIATION 0.291 • n=1425 Participants	4.95 months STANDARD_DEVIATION 0.293 • n=2824 Participants
Sex: Female, Male Female	723 Participants n=1399 Participants	725 Participants n=1425 Participants	1448 Participants n=2824 Participants
Sex: Female, Male Male	676 Participants n=1399 Participants	700 Participants n=1425 Participants	1376 Participants n=2824 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1383 Participants n=1399 Participants	1407 Participants n=1425 Participants	2790 Participants n=2824 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=1399 Participants	5 Participants n=1425 Participants	8 Participants n=2824 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=1399 Participants	13 Participants n=1425 Participants	26 Participants n=2824 Participants
Race/Ethnicity, Customized Race · American Indian or Alaskan Native	1 Participants n=1399 Participants	0 Participants n=1425 Participants	1 Participants n=2824 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=1399 Participants	1 Participants n=1425 Participants	1 Participants n=2824 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=1399 Participants	0 Participants n=1425 Participants	0 Participants n=2824 Participants
Race/Ethnicity, Customized Race · Black or African American	14 Participants n=1399 Participants	9 Participants n=1425 Participants	23 Participants n=2824 Participants
Race/Ethnicity, Customized Race · White	3 Participants n=1399 Participants	1 Participants n=1425 Participants	4 Participants n=2824 Participants
Race/Ethnicity, Customized Race · Other	1302 Participants n=1399 Participants	1327 Participants n=1425 Participants	2629 Participants n=2824 Participants
Race/Ethnicity, Customized Race · More than one race	11 Participants n=1399 Participants	9 Participants n=1425 Participants	20 Participants n=2824 Participants
Race/Ethnicity, Customized Race · Not Reported	53 Participants n=1399 Participants	64 Participants n=1425 Participants	117 Participants n=2824 Participants
Race/Ethnicity, Customized Race · Unknown	15 Participants n=1399 Participants	14 Participants n=1425 Participants	29 Participants n=2824 Participants
Region of Enrollment Colombia	44 participants n=1399 Participants	42 participants n=1425 Participants	86 participants n=2824 Participants
Region of Enrollment Puerto Rico	1 participants n=1399 Participants	1 participants n=1425 Participants	2 participants n=2824 Participants
Region of Enrollment United States	1 participants n=1399 Participants	1 participants n=1425 Participants	2 participants n=2824 Participants
Region of Enrollment Panama	764 participants n=1399 Participants	769 participants n=1425 Participants	1533 participants n=2824 Participants
Region of Enrollment Dominican Republic	273 participants n=1399 Participants	284 participants n=1425 Participants	557 participants n=2824 Participants
Region of Enrollment Honduras	221 participants n=1399 Participants	233 participants n=1425 Participants	454 participants n=2824 Participants
Region of Enrollment Peru	95 participants n=1399 Participants	95 participants n=1425 Participants	190 participants n=2824 Participants
Weight	7.423 kg STANDARD_DEVIATION 0.9861 • n=1397 Participants • Weight not reported for all participants.	7.395 kg STANDARD_DEVIATION 0.9979 • n=1422 Participants • Weight not reported for all participants.	7.409 kg STANDARD_DEVIATION 0.9920 • n=2819 Participants • Weight not reported for all participants.
Length	64.16 cm STANDARD_DEVIATION 2.657 • n=1397 Participants • Length not reported for all participants.	64.05 cm STANDARD_DEVIATION 2.731 • n=1422 Participants • Length not reported for all participants.	64.10 cm STANDARD_DEVIATION 2.694 • n=2819 Participants • Length not reported for all participants.
Head circumference	42.08 cm STANDARD_DEVIATION 1.316 • n=1395 Participants • Head circumference not reported for all participants.	42.06 cm STANDARD_DEVIATION 1.292 • n=1419 Participants • Head circumference not reported for all participants.	42.07 cm STANDARD_DEVIATION 1.304 • n=2814 Participants • Head circumference not reported for all participants.

PRIMARY outcome

Timeframe: The duration of the primary observation period was 6 months starting at 28 days post dose 2.

Population: Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo.

Outcome measures

Outcome measures
Measure	Placebo n=1399 Participants One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57. Placebo: 2 injections - given on Day 1 and the second given between Day 29 - Day 57	Experimental n=1425 Participants One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57. HIL-214: 2 injections - given on Day 1 and the second given between Day 29 - Day 57
To Demonstrate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With GI.1 or GII.4 Norovirus Genotypes.	3.07 months Standard Deviation 2.059	3.29 months Standard Deviation 1.746

SECONDARY outcome

Timeframe: The duration of the primary observation period was 6 months starting at 28 days post dose 2.

Population: Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo.

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.

Outcome measures

Outcome measures
Measure	Placebo n=1399 Participants One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57. Placebo: 2 injections - given on Day 1 and the second given between Day 29 - Day 57	Experimental n=1425 Participants One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57. HIL-214: 2 injections - given on Day 1 and the second given between Day 29 - Day 57
To Evaluate the Efficacy of HIL-214 Vaccine Against Moderate/Severe Acute Gastroenteritis (AGE) Associated Only With Any Norovirus (GI or GII) Genogroup.	3.16 months Standard Deviation 1.886	3.32 months Standard Deviation 1.519

SECONDARY outcome

Timeframe: The duration of the primary observation period was 6 months starting at 28 days post dose 2.

Population: Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo.

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.

Outcome measures

Outcome measures
Measure	Placebo n=1399 Participants One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57. Placebo: 2 injections - given on Day 1 and the second given between Day 29 - Day 57	Experimental n=1425 Participants One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57. HIL-214: 2 injections - given on Day 1 and the second given between Day 29 - Day 57
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.	3.11 months Standard Deviation 1.981	3.29 months Standard Deviation 1.628

SECONDARY outcome

Timeframe: The duration of the primary observation period was 6 months starting at 28 days post dose 2.

Population: Modified Full-Analysis Set (mFAS): The mFAS included all participants who were randomized and received 2 doses of HIL-214 or placebo.

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.

Outcome measures

Outcome measures
Measure	Placebo n=1399 Participants One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57. Placebo: 2 injections - given on Day 1 and the second given between Day 29 - Day 57	Experimental n=1425 Participants One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57. HIL-214: 2 injections - given on Day 1 and the second given between Day 29 - Day 57
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	3.19 months Standard Deviation 1.852	3.17 months Standard Deviation 1.541

SECONDARY outcome

Timeframe: Participant reaches 1 year of age

Population: Full-Analysis Set, The FAS will include all subjects who are randomized and received at least 1 dose of HIL-214 or placebo.

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

Outcome measures

Outcome measures
Measure	Placebo n=1538 Participants One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57. Placebo: 2 injections - given on Day 1 and the second given between Day 29 - Day 57	Experimental n=1540 Participants One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57. HIL-214: 2 injections - given on Day 1 and the second given between Day 29 - Day 57
Immunogenicity of HIL-214 Compared to Placebo Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate at Visit 4	0.2 percentage of participants Interval 0.0 to 0.6	22.9 percentage of participants Interval 20.7 to 25.2
Immunogenicity of HIL-214 Compared to Placebo Anti-GI.1 HBGA-blocking seroresponse rate at Visit 2	0.6 percentage of participants Interval 0.3 to 1.2	36.8 percentage of participants Interval 34.3 to 39.4
Immunogenicity of HIL-214 Compared to Placebo Anti-GI.1 HBGA-blocking seroresponse rate at Visit 3	1.4 percentage of participants Interval 0.8 to 2.1	95.5 percentage of participants Interval 94.3 to 96.6
Immunogenicity of HIL-214 Compared to Placebo Anti-GI.1 HBGA-blocking seroresponse rate at Visit 4	1.6 percentage of participants Interval 1.0 to 2.4	86.2 percentage of participants Interval 84.3 to 88.0
Immunogenicity of HIL-214 Compared to Placebo Anti-GII.4c HBGA-blocking seroresponse rate at Visit 2	1.3 percentage of participants Interval 0.8 to 2.1	7.4 percentage of participants Interval 6.1 to 8.9
Immunogenicity of HIL-214 Compared to Placebo Anti- GII.4c HBGA-blocking seroresponse rate at Visit 3	2.2 percentage of participants Interval 1.5 to 3.2	43.0 percentage of participants Interval 40.4 to 45.6
Immunogenicity of HIL-214 Compared to Placebo Anti- GII.4c HBGA-blocking seroresponse rate at Visit 4	6.2 percentage of participants Interval 5.0 to 7.6	25.0 percentage of participants Interval 22.8 to 27.4
Immunogenicity of HIL-214 Compared to Placebo Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate at Visit 2	0 percentage of participants Interval 0.0 to 0.3	4.8 percentage of participants Interval 3.7 to 6.0
Immunogenicity of HIL-214 Compared to Placebo Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate at Visit 3	0.3 percentage of participants Interval 0.1 to 0.7	42.3 percentage of participants Interval 39.7 to 44.9
Immunogenicity of HIL-214 Compared to Placebo Anti-GI.1 pan-Ig seroresponse rate at Visit 2	1.3 percentage of participants Interval 0.8 to 2.1	84.6 percentage of participants Interval 82.6 to 86.4
Immunogenicity of HIL-214 Compared to Placebo Anti-GI.1 pan-Ig seroresponse rate at Visit 3	2.4 percentage of participants Interval 1.6 to 3.3	98.9 percentage of participants Interval 98.3 to 99.4
Immunogenicity of HIL-214 Compared to Placebo Anti-GI.1 pan-Ig seroresponse rate at Visit 4	8.7 percentage of participants Interval 7.2 to 10.3	97.1 percentage of participants Interval 96.0 to 97.9
Immunogenicity of HIL-214 Compared to Placebo Anti-GII.4c pan-Ig seroresponse rate at Visit 2	3.3 percentage of participants Interval 2.5 to 4.4	37.9 percentage of participants Interval 35.4 to 40.5
Immunogenicity of HIL-214 Compared to Placebo Anti-GII.4c pan-Ig seroresponse rate at Visit 3	8.1 percentage of participants Interval 6.7 to 9.7	83.9 percentage of participants Interval 81.9 to 85.8
Immunogenicity of HIL-214 Compared to Placebo Anti-GII.4c pan-Ig seroresponse rate at Visit 4	23.6 percentage of participants Interval 21.4 to 26.0	75.5 percentage of participants Interval 73.1 to 77.7
Immunogenicity of HIL-214 Compared to Placebo Anti-GI.1 and GII.4c pan-Ig seroresponse rate at Visit 2	0.3 percentage of participants Interval 0.1 to 0.7	35.9 percentage of participants Interval 33.4 to 38.4
Immunogenicity of HIL-214 Compared to Placebo Anti-GI.1 and GII.4c pan-Ig seroresponse rate at Visit 3	1.0 percentage of participants Interval 0.6 to 1.7	83.5 percentage of participants Interval 81.4 to 85.4
Immunogenicity of HIL-214 Compared to Placebo Anti- GI.1 and GII.4c pan-Ig seroresponse rate at Visit 4	4.7 percentage of participants Interval 3.7 to 6.0	74.7 percentage of participants Interval 72.3 to 76.9

SECONDARY outcome

Timeframe: Up to 7 days after each dose of HIL-214 or placebo.

Population: Safety Analysis Set, all participants who were randomized and received at least 1 dose of trial vaccine (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.

Outcome measures

Outcome measures
Measure	Placebo n=1536 Participants One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57. Placebo: 2 injections - given on Day 1 and the second given between Day 29 - Day 57	Experimental n=1541 Participants One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57. HIL-214: 2 injections - given on Day 1 and the second given between Day 29 - Day 57
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events (AEs) Any solicited local AE	6.7 percentage of participants	10.4 percentage of participants
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events (AEs) Injection site pain	5.4 percentage of participants	8.2 percentage of participants
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events (AEs) Erythema	1.8 percentage of participants	2.0 percentage of participants
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events (AEs) Induration	0 percentage of participants	0.7 percentage of participants
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events (AEs) Swelling	0.1 percentage of participants	0.5 percentage of participants

SECONDARY outcome

Timeframe: Up to 7 days after each dose of HIL-214 or placebo.

Population: Safety Analysis Set, all participants that received at least 1 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.

Outcome measures

Outcome measures
Measure	Placebo n=1536 Participants One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57. Placebo: 2 injections - given on Day 1 and the second given between Day 29 - Day 57	Experimental n=1541 Participants One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57. HIL-214: 2 injections - given on Day 1 and the second given between Day 29 - Day 57
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs) Any solicited systemic AE	35.2 percentage of participants	37.7 percentage of participants
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs) Drowsiness	10.7 percentage of participants	12.7 percentage of participants
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs) Irritability/fussiness	18.0 percentage of participants	20.2 percentage of participants
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs) Loss of appetite	7.9 percentage of participants	8.4 percentage of participants
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs) Vomiting	7.4 percentage of participants	8.6 percentage of participants
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events (AEs) Diarrhea	14.6 percentage of participants	15.4 percentage of participants

SECONDARY outcome

Timeframe: Up to 28 days after first dose of HIL-214 or placebo.

Population: Safety Analysis Set; all participants that received at least 1 dose of HIL 214 or placebo.

Percentage of participants with AEs leading to trial vaccine dose withdrawal.

Outcome measures

Outcome measures
Measure	Placebo n=1536 Participants One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57. Placebo: 2 injections - given on Day 1 and the second given between Day 29 - Day 57	Experimental n=1541 Participants One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57. HIL-214: 2 injections - given on Day 1 and the second given between Day 29 - Day 57
Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Vaccine Withdrawal	0 percentage of participants	0.1 percentage of participants

SECONDARY outcome

Timeframe: From Day 1 to end of the trial/early termination.

Population: Safety Analysis Set; all participants that received at least 1 dose of HIL-214 or placebo.

Percentage of participants with AEs leading to trial withdrawal.

Outcome measures

Outcome measures
Measure	Placebo n=1536 Participants One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57. Placebo: 2 injections - given on Day 1 and the second given between Day 29 - Day 57	Experimental n=1541 Participants One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57. HIL-214: 2 injections - given on Day 1 and the second given between Day 29 - Day 57
Safety of HIL-214 Compared to Placebo - Adverse Events (AEs) Leading to Trial Withdrawal.	0.1 percentage of participants	0.1 percentage of participants

Adverse Events

Placebo

Serious events: 165 serious events

Other events: 889 other events

Deaths: 1 deaths

Experimental

Serious events: 169 serious events

Other events: 902 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=1536 participants at risk One dose of placebo on Day 1 and one dose of placebo between Day 28 and Day 56.	Experimental n=1541 participants at risk One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 28 and Day 56.
Infections and infestations Nasopharyngitis	30.9% 474/1536 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.	31.9% 492/1541 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.
Infections and infestations Gastroenteritis	17.4% 268/1536 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.	18.5% 285/1541 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.
Infections and infestations Upper respiratory tract infection	4.9% 75/1536 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.	4.5% 69/1541 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.
Infections and infestations Bronchiolitis	2.5% 39/1536 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.	3.0% 47/1541 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.
Skin and subcutaneous tissue disorders Dermatitis diaper	3.6% 55/1536 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.	4.2% 64/1541 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.
Gastrointestinal disorders Diarrhea	2.6% 40/1536 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.	2.0% 31/1541 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.
Blood and lymphatic system disorders Anemia	2.0% 30/1536 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.	1.5% 23/1541 • Deaths from Day 1 to the end of 6 month observation period; Serious adverse events from Day 1 to the end of the trial; Unsolicited adverse events for up to 28 days after any dose of trial vaccine. Serious adverse events that occurred are reported at the preferred term level in the safety analysis set.

Additional Information

Astrid Borkowski, Chief Medical Officer

HilleVax, Inc.

Phone: +1 (617) 213-6562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place