Trial Outcomes & Findings for Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants (NCT NCT06007781)
NCT ID: NCT06007781
Last Updated: 2025-03-14
Results Overview
Percentage of Participants with Adverse Events (AEs) Leading to Trial Withdrawal
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
Day 1 to 6 months post-dose 2
Results posted on
2025-03-14
Participant Flow
Participants took part in the trial at 4 investigative sites in Japan from 18 August 2023 to 27 May 2024
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
| Measure |
Placebo
One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
|
HIL-214
One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
14
|
|
Overall Study
COMPLETED
|
7
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants
Baseline characteristics by cohort
| Measure |
Placebo
n=7 Participants
One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
|
HIL-214
n=14 Participants
One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
152.9 days
STANDARD_DEVIATION 7.60 • n=5 Participants
|
150.9 days
STANDARD_DEVIATION 7.72 • n=7 Participants
|
151.6 days
STANDARD_DEVIATION 7.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
7 participants
n=5 Participants
|
14 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Weight
|
7.23 kg
STANDARD_DEVIATION 0.596 • n=5 Participants
|
7.31 kg
STANDARD_DEVIATION 0.815 • n=7 Participants
|
7.29 kg
STANDARD_DEVIATION 0.735 • n=5 Participants
|
|
Length
|
63.96 cm
STANDARD_DEVIATION 1.936 • n=5 Participants
|
64.27 cm
STANDARD_DEVIATION 2.083 • n=7 Participants
|
64.17 cm
STANDARD_DEVIATION 1.992 • n=5 Participants
|
|
Head circumference
|
41.86 cm
STANDARD_DEVIATION 1.282 • n=5 Participants
|
41.66 cm
STANDARD_DEVIATION 1.873 • n=7 Participants
|
41.73 cm
STANDARD_DEVIATION 1.668 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 6 months post-dose 2Population: Safety Analysis Set, all participants that received trial vaccine (HIL 214 or placebo).
Percentage of Participants with Adverse Events (AEs) Leading to Trial Withdrawal
Outcome measures
| Measure |
Placebo
n=7 Participants
One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
|
HIL-214
n=14 Participants
One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57
|
|---|---|---|
|
Safety of HIL-214 Compared to Placebo - AEs Leading to Trial Withdrawal
|
0 Percentage of Participants
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2 (Day 36 to Day 56)Population: Safety Analysis Set, all participants that received trial vaccine (HIL 214 or placebo).
Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days of Vaccine Administration (any dose). Assessed AEs included pain, erythema, induration, and swelling.
Outcome measures
| Measure |
Placebo
n=7 Participants
One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
|
HIL-214
n=14 Participants
One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57
|
|---|---|---|
|
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events
Erythema
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
|
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events
Induration
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
|
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events
Swelling
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
|
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events
Any solicited local AE
|
0 Percentage of Participants
|
42.9 Percentage of Participants
|
|
Safety of HIL-214 Compared to Placebo - Solicited Local Adverse Events
Pain
|
0 Percentage of Participants
|
14.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7 post-dose 1 and Day 1 to Day 7 post-dose 2 (Day 36 to Day 56)Population: Safety Analysis Set, all participants that received trial vaccine (HIL 214 or placebo).
Percentage of Participants with Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration. Assessed AEs included drowsiness, irritability/fussiness, loss of appetite, fever, vomiting, and diarrhea.
Outcome measures
| Measure |
Placebo
n=7 Participants
One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
|
HIL-214
n=14 Participants
One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57
|
|---|---|---|
|
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events
Loss of appetite
|
0 Percentage of Participants
|
21.4 Percentage of Participants
|
|
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events
Fever
|
0 Percentage of Participants
|
7.1 Percentage of Participants
|
|
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events
Vomiting
|
0 Percentage of Participants
|
21.4 Percentage of Participants
|
|
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events
Any solicited systemic AE
|
14.3 Percentage of Participants
|
64.3 Percentage of Participants
|
|
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events
Drowsiness
|
14.3 Percentage of Participants
|
35.7 Percentage of Participants
|
|
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events
Irritability/fussiness
|
0 Percentage of Participants
|
35.7 Percentage of Participants
|
|
Safety of HIL-214 Compared to Placebo - Solicited Systemic Adverse Events
Diarrhea
|
0 Percentage of Participants
|
35.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to 56 days post-dose 1Population: Safety Analysis Set, all participants that received trial vaccine (HIL 214 or placebo).
Percentage of participants with AEs that lead to withdrawal of trial vaccine up to the planned time of second dose administration.
Outcome measures
| Measure |
Placebo
n=7 Participants
One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
|
HIL-214
n=14 Participants
One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57
|
|---|---|---|
|
Safety of HIL-214 Compared to Placebo - Percentage of Participants With AEs Leading to Vaccine Withdrawal
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Day 1 to 6 months post-dose 2Population: Per-Protocol Set, all participants who received trial vaccine (HIL-214 or placebo) and had no major protocol deviations.
The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration) at Visit 2, Visit 3, and/or 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
| Measure |
Placebo
n=7 Participants
One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
|
HIL-214
n=13 Participants
One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57
|
|---|---|---|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GI.1 HBGA-blocking seroresponse rate at Visit 2
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
87.5 Percentage of Participants
Interval 47.3 to 99.7
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GI.1 HBGA-blocking seroresponse rate at Visit 3
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
100 Percentage of Participants
Interval 73.5 to 100.0
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GI.1 HBGA-blocking seroresponse rate at Visit 4
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
100 Percentage of Participants
Interval 73.5 to 100.0
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GII.4c HBGA-blocking seroresponse rate at Visit 2
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
23.1 Percentage of Participants
Interval 5.0 to 53.8
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti- GII.4c HBGA-blocking seroresponse rate at Visit 3
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
92.3 Percentage of Participants
Interval 64.0 to 99.8
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti- GII.4c HBGA-blocking seroresponse rate at Visit 4
|
28.6 Percentage of Participants
Interval 3.7 to 71.0
|
84.6 Percentage of Participants
Interval 54.6 to 98.1
|
|
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 41.1
|
37.5 Percentage of Participants
Interval 8.5 to 75.5
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GI.1 and GII.4c HBGA-blocking seroresponse rate at Visit 3
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
91.7 Percentage of Participants
Interval 61.5 to 99.8
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti- GI.1 and GII.4c HBGA-blocking seroresponse rate at Visit 4
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
84.6 Percentage of Participants
Interval 54.6 to 98.1
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GI.1 pan-Ig seroresponse rate at Visit 2
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
100 Percentage of Participants
Interval 75.3 to 100.0
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GI.1 pan-Ig seroresponse rate at Visit 3
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
100 Percentage of Participants
Interval 75.3 to 100.0
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GI.1 pan-Ig seroresponse rate at Visit 4
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
100 Percentage of Participants
Interval 75.3 to 100.0
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GII.4c pan-Ig seroresponse rate at Visit 2
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
69.2 Percentage of Participants
Interval 38.6 to 90.9
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GII.4c pan-Ig seroresponse rate at Visit 3
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
100 Percentage of Participants
Interval 75.3 to 100.0
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GII.4c pan-Ig seroresponse rate at Visit 4
|
28.6 Percentage of Participants
Interval 3.7 to 71.0
|
84.6 Percentage of Participants
Interval 54.6 to 98.1
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GI.1 and GII.4c pan-Ig seroresponse rate at Visit 2
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
69.2 Percentage of Participants
Interval 38.6 to 90.9
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti-GI.1 and GII.4c pan-Ig seroresponse rate at Visit 3
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
100 Percentage of Participants
Interval 75.3 to 100.0
|
|
Immunogenicity of HIL-214 Compared to Placebo.
Anti- GI.1 and GII.4c pan-Ig seroresponse rate at Visit 4
|
0 Percentage of Participants
Interval 0.0 to 41.1
|
84.6 Percentage of Participants
Interval 54.6 to 98.1
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
HIL-214
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=7 participants at risk
One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
|
HIL-214
n=14 participants at risk
One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57
|
|---|---|---|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
7.1%
1/14 • Number of events 1 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
7.1%
1/14 • Number of events 1 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
Other adverse events
| Measure |
Placebo
n=7 participants at risk
One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
|
HIL-214
n=14 participants at risk
One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
7.1%
1/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Infections and infestations
Conjunctivitis
|
14.3%
1/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
0.00%
0/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
7.1%
1/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Infections and infestations
Nasopharyngitis
|
57.1%
4/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
21.4%
3/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
14.3%
2/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
28.6%
2/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
14.3%
2/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
14.3%
1/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
0.00%
0/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
7.1%
1/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
7.1%
1/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Skin and subcutaneous tissue disorders
Eczema infantile
|
0.00%
0/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
14.3%
2/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
1/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
14.3%
2/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
0.00%
0/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
7.1%
1/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
14.3%
2/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
14.3%
1/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
7.1%
1/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
7.1%
1/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/7 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
7.1%
1/14 • Serious adverse events from Day 1 to 6 months post-dose 2; Unsolicited adverse events from Day 1 to 28 days post-dose 1 and Day 1 to 28 days post-dose 2.
|
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
Restriction type: OTHER