Trial Outcomes & Findings for Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults (NCT NCT06602531)
NCT ID: NCT06602531
Last Updated: 2026-09-04
Results Overview
The following solicited local and systemic AEs were recorded from Day 1 to 7 days after each vaccination (dose): Injection site pain, Erythema, Swelling, Fatigue, Headache, Myalgia, Arthralgia, Dizziness, Nausea, Chills, Fever (≥100.4 °Fahrenheit \[F\] /≥38.0 °Celsius \[C\]). A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
212 participants
Primary outcome timeframe
7 days post each dose
Results posted on
2026-09-04
Participant Flow
Participant milestones
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
Participants received 1.5 micrograms (µg) ARCT-2304 intramuscularly (IM) on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
27
|
27
|
27
|
27
|
26
|
26
|
|
Overall Study
Received at least 1 dose of trial drug
|
26
|
26
|
27
|
27
|
27
|
27
|
26
|
26
|
|
Overall Study
COMPLETED
|
26
|
25
|
26
|
24
|
23
|
26
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
3
|
4
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
Participants received 1.5 micrograms (µg) ARCT-2304 intramuscularly (IM) on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
3
|
2
|
0
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
2
|
0
|
0
|
2
|
Baseline Characteristics
Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults
Baseline characteristics by cohort
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=26 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=26 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=27 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: Control/Placebo
n=27 Participants
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=27 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=27 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=26 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
n=26 Participants
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.1 Years
STANDARD_DEVIATION 14.56 • n=23 Participants
|
52.5 Years
STANDARD_DEVIATION 15.39 • n=23 Participants
|
53.3 Years
STANDARD_DEVIATION 12.36 • n=22 Participants
|
51.9 Years
STANDARD_DEVIATION 15.78 • n=21 Participants
|
53.3 Years
STANDARD_DEVIATION 17.31 • n=24 Participants
|
52.7 Years
STANDARD_DEVIATION 15.00 • n=113 Participants
|
54.9 Years
STANDARD_DEVIATION 15.49 • n=912 Participants
|
54.2 Years
STANDARD_DEVIATION 13.59 • n=3 Participants
|
53.2 Years
STANDARD_DEVIATION 14.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=23 Participants
|
15 Participants
n=23 Participants
|
16 Participants
n=22 Participants
|
17 Participants
n=21 Participants
|
19 Participants
n=24 Participants
|
17 Participants
n=113 Participants
|
12 Participants
n=912 Participants
|
15 Participants
n=3 Participants
|
121 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=23 Participants
|
11 Participants
n=23 Participants
|
11 Participants
n=22 Participants
|
10 Participants
n=21 Participants
|
8 Participants
n=24 Participants
|
10 Participants
n=113 Participants
|
14 Participants
n=912 Participants
|
11 Participants
n=3 Participants
|
91 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=23 Participants
|
4 Participants
n=23 Participants
|
5 Participants
n=22 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=113 Participants
|
2 Participants
n=912 Participants
|
1 Participants
n=3 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=23 Participants
|
22 Participants
n=23 Participants
|
22 Participants
n=22 Participants
|
25 Participants
n=21 Participants
|
25 Participants
n=24 Participants
|
25 Participants
n=113 Participants
|
23 Participants
n=912 Participants
|
25 Participants
n=3 Participants
|
192 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=113 Participants
|
1 Participants
n=912 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=23 Participants
|
20 Participants
n=23 Participants
|
19 Participants
n=22 Participants
|
19 Participants
n=21 Participants
|
19 Participants
n=24 Participants
|
22 Participants
n=113 Participants
|
19 Participants
n=912 Participants
|
20 Participants
n=3 Participants
|
159 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=912 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=912 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=23 Participants
|
6 Participants
n=23 Participants
|
6 Participants
n=22 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=113 Participants
|
5 Participants
n=912 Participants
|
3 Participants
n=3 Participants
|
41 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=912 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=113 Participants
|
2 Participants
n=912 Participants
|
0 Participants
n=3 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=113 Participants
|
0 Participants
n=912 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=912 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7 days post each dosePopulation: SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
The following solicited local and systemic AEs were recorded from Day 1 to 7 days after each vaccination (dose): Injection site pain, Erythema, Swelling, Fatigue, Headache, Myalgia, Arthralgia, Dizziness, Nausea, Chills, Fever (≥100.4 °Fahrenheit \[F\] /≥38.0 °Celsius \[C\]). A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=26 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=26 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=27 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=27 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=27 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=27 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=26 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
n=26 Participants
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Adverse Events (AEs) Within 7 Days After Each Vaccination
Post dose 1
|
17 Participants
|
22 Participants
|
23 Participants
|
19 Participants
|
17 Participants
|
23 Participants
|
23 Participants
|
19 Participants
|
|
Number of Participants With Solicited Adverse Events (AEs) Within 7 Days After Each Vaccination
Post dose 2
|
15 Participants
|
22 Participants
|
24 Participants
|
11 Participants
|
14 Participants
|
21 Participants
|
20 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: D1,29 Cohorts: up to Day 29 and up to Day 57 (28 days post each dose), D1,57 Cohorts: up to Day 29 and up to Day 85 (28 days post each dose)Population: SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
An AE was any untoward medical occurrence in a participant or participant administered a medicinal product, whether or not considered related to the trial vaccine. An unsolicited AE was defined as any AE not included in the list of solicited AEs (i.e., any event other than injection site pain, erythema, swelling, fatigue, headache, myalgia, arthralgia, dizziness, nausea, chills, or fever (≥100.4 °F / ≥38.0 °C). Solicited AEs that lasted for more than 7 days were considered as unsolicited AEs. Unsolicited AEs were recorded from Day 1 up to 28 days after each vaccination (dose). A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section'.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=26 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=26 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=27 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=27 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=27 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=27 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=26 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
n=26 Participants
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs Within 28 Days After Each Vaccination
Post dose 1
|
7 Participants
|
7 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With Unsolicited AEs Within 28 Days After Each Vaccination
Post dose 2
|
6 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: D1,29 Cohorts: up to Day 57, D1,57 Cohorts: up to Day 85Population: SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
An SAE was defined as any AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity, or required inpatient hospitalization or prolongation of existing hospitalization. AEs potentially associated with messenger ribonucleic acid (mRNA) vaccines and influenza vaccines were reported as AESIs. MAAEs were defined as AEs with medically attended visits including hospital, emergency room, urgent care clinic, or other visits (including phone/telehealth visits) to or from medical personnel for any reason but did not fulfil seriousness criteria. A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section'.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=26 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=26 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=27 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=27 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=27 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=27 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=26 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
n=26 Participants
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading To Early Termination From Day 1 to 28 Days After Second Vaccination
AE leading to early termination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading To Early Termination From Day 1 to 28 Days After Second Vaccination
MAAE
|
4 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading To Early Termination From Day 1 to 28 Days After Second Vaccination
AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs of Special Interest (AESIs), and AEs Leading To Early Termination From Day 1 to 28 Days After Second Vaccination
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: D1,29 Cohorts: Day 1, Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 1, Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)Population: Per Protocol Set (PPS) included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Antibody titers were expressed as Geometric Mean Titers.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=24 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Antibody Response to Hemagglutinin (HA) Glycoprotein Measured By Hemagglutinin Inhibition (HAI) Assay
7 days post dose 2
|
13.5 Titer
Interval 8.9 to 20.4
|
25.7 Titer
Interval 16.5 to 40.1
|
35.5 Titer
Interval 27.6 to 45.5
|
26.4 Titer
Interval 17.6 to 39.5
|
33.1 Titer
Interval 24.9 to 44.0
|
63.5 Titer
Interval 50.1 to 80.4
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response to Hemagglutinin (HA) Glycoprotein Measured By Hemagglutinin Inhibition (HAI) Assay
Day 1
|
5.0 Titer
Interval 5.0 to 5.0
|
5.0 Titer
Interval 5.0 to 5.0
|
5.4 Titer
Interval 4.6 to 6.3
|
5.5 Titer
Interval 4.5 to 6.9
|
5.0 Titer
Interval 5.0 to 5.0
|
5.6 Titer
Interval 4.4 to 7.2
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response to Hemagglutinin (HA) Glycoprotein Measured By Hemagglutinin Inhibition (HAI) Assay
28 days post dose 1
|
5.5 Titer
Interval 4.8 to 6.3
|
7.5 Titer
Interval 5.3 to 10.7
|
8.9 Titer
Interval 6.1 to 12.9
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response to Hemagglutinin (HA) Glycoprotein Measured By Hemagglutinin Inhibition (HAI) Assay
56 days post dose 1
|
—
|
—
|
—
|
7.4 Titer
Interval 5.2 to 10.6
|
7.4 Titer
Interval 5.5 to 9.9
|
10.0 Titer
Interval 6.8 to 14.8
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response to Hemagglutinin (HA) Glycoprotein Measured By Hemagglutinin Inhibition (HAI) Assay
28 days post dose 2
|
17.8 Titer
Interval 12.0 to 26.4
|
35.3 Titer
Interval 23.7 to 52.5
|
41.7 Titer
Interval 32.3 to 53.9
|
37.3 Titer
Interval 23.7 to 58.9
|
54.8 Titer
Interval 42.7 to 70.4
|
77.0 Titer
Interval 63.4 to 93.6
|
—
|
—
|
PRIMARY outcome
Timeframe: D1,29 Cohorts: Day 1, Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 1, Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Antibody titers were expressed as Geometric Mean Titers.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=24 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Antibody Response to Neuraminidase (NA) Glycoprotein Measured By Enzyme-linked Lectin Assay (ELLA)
7 days post dose 2
|
647.8 Titer
Interval 412.5 to 1017.5
|
978.7 Titer
Interval 720.7 to 1329.1
|
1183.6 Titer
Interval 806.0 to 1738.0
|
598.2 Titer
Interval 385.2 to 929.0
|
1051.5 Titer
Interval 725.9 to 1523.1
|
1317.5 Titer
Interval 995.0 to 1744.4
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response to Neuraminidase (NA) Glycoprotein Measured By Enzyme-linked Lectin Assay (ELLA)
56 days post dose 1
|
—
|
—
|
—
|
498.8 Titer
Interval 312.0 to 797.3
|
880.9 Titer
Interval 593.9 to 1306.7
|
908.7 Titer
Interval 581.6 to 1419.7
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response to Neuraminidase (NA) Glycoprotein Measured By Enzyme-linked Lectin Assay (ELLA)
Day 1
|
56.8 Titer
Interval 34.3 to 94.0
|
44.3 Titer
Interval 25.6 to 76.6
|
29.5 Titer
Interval 17.1 to 51.0
|
41.2 Titer
Interval 19.5 to 87.1
|
40.7 Titer
Interval 24.5 to 67.6
|
32.0 Titer
Interval 18.8 to 54.6
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response to Neuraminidase (NA) Glycoprotein Measured By Enzyme-linked Lectin Assay (ELLA)
28 days post dose 1
|
641.5 Titer
Interval 399.8 to 1029.2
|
857.0 Titer
Interval 615.9 to 1192.4
|
1129.3 Titer
Interval 745.7 to 1710.3
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response to Neuraminidase (NA) Glycoprotein Measured By Enzyme-linked Lectin Assay (ELLA)
28 days post dose 2
|
817.5 Titer
Interval 525.7 to 1271.2
|
965.5 Titer
Interval 685.3 to 1360.2
|
1311.4 Titer
Interval 866.4 to 1984.9
|
800.5 Titer
Interval 518.2 to 1236.5
|
1266.7 Titer
Interval 917.4 to 1749.2
|
1679.7 Titer
Interval 1272.4 to 2217.4
|
—
|
—
|
PRIMARY outcome
Timeframe: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Geometric Mean Fold Rise was reported as a ratio to Day 1.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=24 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By HAI Assay
28 days post dose 1
|
1.1 Ratio
Interval 1.0 to 1.3
|
1.5 Ratio
Interval 1.1 to 2.1
|
1.6 Ratio
Interval 1.2 to 2.3
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By HAI Assay
56 days post dose 1
|
—
|
—
|
—
|
1.3 Ratio
Interval 1.0 to 1.8
|
1.5 Ratio
Interval 1.1 to 2.0
|
1.8 Ratio
Interval 1.1 to 3.0
|
—
|
—
|
|
Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By HAI Assay
7 days post dose 2
|
2.7 Ratio
Interval 1.8 to 4.1
|
5.1 Ratio
Interval 3.3 to 8.0
|
6.5 Ratio
Interval 5.3 to 8.1
|
4.8 Ratio
Interval 3.2 to 7.1
|
6.6 Ratio
Interval 5.0 to 8.8
|
11.3 Ratio
Interval 7.7 to 16.5
|
—
|
—
|
|
Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By HAI Assay
28 days post dose 2
|
3.6 Ratio
Interval 2.4 to 5.3
|
7.1 Ratio
Interval 4.7 to 10.5
|
7.8 Ratio
Interval 6.1 to 9.8
|
6.7 Ratio
Interval 4.2 to 10.9
|
11.0 Ratio
Interval 8.5 to 14.1
|
13.7 Ratio
Interval 9.5 to 19.9
|
—
|
—
|
PRIMARY outcome
Timeframe: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Geometric Mean Fold Rise was reported as a ratio to Day 1.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=24 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise of Antibody Response to NA Glycoprotein Measured By ELLA
28 days post dose 1
|
11.3 Ratio
Interval 8.0 to 16.0
|
19.3 Ratio
Interval 12.3 to 30.4
|
38.2 Ratio
Interval 26.6 to 55.0
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise of Antibody Response to NA Glycoprotein Measured By ELLA
56 days post dose 1
|
—
|
—
|
—
|
12.1 Ratio
Interval 7.4 to 19.7
|
21.6 Ratio
Interval 12.8 to 36.6
|
28.4 Ratio
Interval 15.4 to 52.3
|
—
|
—
|
|
Geometric Mean Fold Rise of Antibody Response to NA Glycoprotein Measured By ELLA
7 days post dose 2
|
12.1 Ratio
Interval 8.6 to 17.2
|
22.1 Ratio
Interval 14.3 to 34.2
|
40.5 Ratio
Interval 27.1 to 60.6
|
14.5 Ratio
Interval 8.6 to 24.4
|
25.8 Ratio
Interval 15.7 to 43.1
|
41.1 Ratio
Interval 21.7 to 78.0
|
—
|
—
|
|
Geometric Mean Fold Rise of Antibody Response to NA Glycoprotein Measured By ELLA
28 days post dose 2
|
14.4 Ratio
Interval 10.2 to 20.3
|
21.8 Ratio
Interval 12.9 to 36.7
|
44.4 Ratio
Interval 28.7 to 68.6
|
19.4 Ratio
Interval 10.9 to 34.5
|
31.1 Ratio
Interval 19.3 to 50.0
|
52.4 Ratio
Interval 28.2 to 97.6
|
—
|
—
|
PRIMARY outcome
Timeframe: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Seroconversion was recorded if participant had pre-vaccination antibody titer \< Lower Limit Of Quantitation (LLOQ) and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By HAI Assay
28 days post dose 1
|
0.0 Percentage of Participants
Interval 0.0 to 14.8
|
13.6 Percentage of Participants
Interval 2.9 to 34.9
|
13.0 Percentage of Participants
Interval 2.8 to 33.6
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By HAI Assay
56 days post dose 1
|
—
|
—
|
—
|
5.0 Percentage of Participants
Interval 0.1 to 24.9
|
4.6 Percentage of Participants
Interval 0.1 to 22.8
|
11.1 Percentage of Participants
Interval 1.4 to 34.7
|
—
|
—
|
|
Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By HAI Assay
7 days post dose 2
|
30.4 Percentage of Participants
Interval 13.2 to 52.9
|
50.0 Percentage of Participants
Interval 28.2 to 71.8
|
59.1 Percentage of Participants
Interval 36.4 to 79.3
|
55.0 Percentage of Participants
Interval 31.5 to 76.9
|
68.2 Percentage of Participants
Interval 45.1 to 86.1
|
94.4 Percentage of Participants
Interval 72.7 to 99.9
|
—
|
—
|
|
Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By HAI Assay
28 days post dose 2
|
37.5 Percentage of Participants
Interval 18.8 to 59.4
|
59.1 Percentage of Participants
Interval 36.4 to 79.3
|
65.2 Percentage of Participants
Interval 42.7 to 83.6
|
60.0 Percentage of Participants
Interval 36.1 to 80.9
|
95.5 Percentage of Participants
Interval 77.2 to 99.9
|
94.4 Percentage of Participants
Interval 72.7 to 99.9
|
—
|
—
|
PRIMARY outcome
Timeframe: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Seroconversion was recorded if participant had pre-vaccination antibody titer \< LLOQ and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=24 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion of Antibody Response to NA Glycoprotein Measured By ELLA
28 days post dose 1
|
87.5 Percentage of Participants
Interval 67.6 to 97.3
|
90.9 Percentage of Participants
Interval 70.8 to 98.9
|
100.0 Percentage of Participants
Interval 85.8 to 100.0
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroconversion of Antibody Response to NA Glycoprotein Measured By ELLA
56 days post dose 1
|
—
|
—
|
—
|
90.0 Percentage of Participants
Interval 68.3 to 98.38
|
100.0 Percentage of Participants
Interval 84.6 to 100.0
|
100.0 Percentage of Participants
Interval 81.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Seroconversion of Antibody Response to NA Glycoprotein Measured By ELLA
7 days post dose 2
|
87.0 Percentage of Participants
Interval 66.4 to 97.2
|
100.0 Percentage of Participants
Interval 84.6 to 100.0
|
95.7 Percentage of Participants
Interval 78.1 to 99.9
|
90.0 Percentage of Participants
Interval 68.3 to 98.8
|
100.0 Percentage of Participants
Interval 84.6 to 100.0
|
100.0 Percentage of Participants
Interval 81.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Seroconversion of Antibody Response to NA Glycoprotein Measured By ELLA
28 days post dose 2
|
91.7 Percentage of Participants
Interval 73.0 to 99.0
|
90.9 Percentage of Participants
Interval 70.8 to 98.9
|
100.0 Percentage of Participants
Interval 85.8 to 100.0
|
95.0 Percentage of Participants
Interval 75.1 to 99.9
|
100.0 Percentage of Participants
Interval 84.6 to 100.0
|
100.0 Percentage of Participants
Interval 81.5 to 100.0
|
—
|
—
|
PRIMARY outcome
Timeframe: D1,29 Cohorts: Day 57 (28 days post dose 2), D1,57 Cohorts: Day 85 (28 days post dose 2)Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=24 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HAI Titers Above or Equal to Prespecified Thresholds
≥1:10
|
75.0 Percentage of Participants
|
95.5 Percentage of Participants
|
100 Percentage of Participants
|
90.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With HAI Titers Above or Equal to Prespecified Thresholds
≥1:20
|
62.5 Percentage of Participants
|
86.4 Percentage of Participants
|
100.0 Percentage of Participants
|
85.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With HAI Titers Above or Equal to Prespecified Thresholds
≥1:40
|
37.5 Percentage of Participants
|
59.1 Percentage of Participants
|
66.7 Percentage of Participants
|
65.0 Percentage of Participants
|
95.5 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With HAI Titers Above or Equal to Prespecified Thresholds
≥1:80
|
8.3 Percentage of Participants
|
22.7 Percentage of Participants
|
25.0 Percentage of Participants
|
40.0 Percentage of Participants
|
31.8 Percentage of Participants
|
77.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With HAI Titers Above or Equal to Prespecified Thresholds
≥1:160
|
0.0 Percentage of Participants
|
9.1 Percentage of Participants
|
8.3 Percentage of Participants
|
5.0 Percentage of Participants
|
9.1 Percentage of Participants
|
11.1 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With HAI Titers Above or Equal to Prespecified Thresholds
≥1:320
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
4.5 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: D1,29 Cohorts: Day 57 (28 days post dose 2), D1,57 Cohorts: Day 85 (28 days post dose 2)Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=24 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ELLA Titers Above or Equal to Prespecified Thresholds
≥1:320
|
83.3 Percentage of Participants
|
95.5 Percentage of Participants
|
87.5 Percentage of Participants
|
75.0 Percentage of Participants
|
95.5 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With ELLA Titers Above or Equal to Prespecified Thresholds
≥1:10
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With ELLA Titers Above or Equal to Prespecified Thresholds
≥1:20
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With ELLA Titers Above or Equal to Prespecified Thresholds
≥1:40
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With ELLA Titers Above or Equal to Prespecified Thresholds
≥1:80
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With ELLA Titers Above or Equal to Prespecified Thresholds
≥1:160
|
91.7 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to Day 240Population: SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
A SAE was defined as any AE that resulted in death, was life-threatening, resulted in persistent disability/incapacity, or required inpatient hospitalization or prolongation of existing hospitalization. AEs potentially associated with mRNA vaccines and influenza vaccines were reported as AESIs. MAAEs were defined as AEs with medically attended visits including hospital, emergency room, urgent care clinic, or other visits (including phone/telehealth visits) to or from medical personnel for any reason, but did not fulfil seriousness criteria. A summary of all Serious Adverse Events and Other Adverse Events (non-serious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=26 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=26 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=27 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=27 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=27 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=27 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=26 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
n=26 Participants
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With SAEs, MAAEs, AESIs, and AEs Leading To Early Termination From Day 1 to Day 240
AESI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With SAEs, MAAEs, AESIs, and AEs Leading To Early Termination From Day 1 to Day 240
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With SAEs, MAAEs, AESIs, and AEs Leading To Early Termination From Day 1 to Day 240
AE leading to early termination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With SAEs, MAAEs, AESIs, and AEs Leading To Early Termination From Day 1 to Day 240
MAAE
|
4 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 240Population: PPS included all participants who received 1 dose of trial vaccine, provided at least one post-baseline immunogenicity assessment, correctly received the assigned protocol-required dose of trial vaccine and had no protocol deviations impacting the analysis of immunogenicity data. As prespecified, this immunogenicity analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Antibody titers were expressed as Geometric Mean Titers.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=21 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=19 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=20 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Antibody Response To HA Glycoprotein Measured By HAI Assay at Day 240
|
5.3 Geometric mean titer
Interval 4.7 to 6.0
|
7.9 Geometric mean titer
Interval 5.7 to 11.1
|
8.1 Geometric mean titer
Interval 5.8 to 11.4
|
9.6 Geometric mean titer
Interval 6.6 to 14.1
|
10.0 Geometric mean titer
Interval 6.6 to 15.2
|
18.2 Geometric mean titer
Interval 12.2 to 27.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 240Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Antibody titers were expressed as Geometric Mean Titers.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=21 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=19 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=20 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Antibody Response to NA Glycoprotein Measured By ELLA at Day 240
|
310.4 Geometric mean titer
Interval 203.8 to 473.0
|
468.0 Geometric mean titer
Interval 327.5 to 668.9
|
435.7 Geometric mean titer
Interval 282.6 to 671.8
|
355.1 Geometric mean titer
Interval 206.2 to 611.6
|
559.2 Geometric mean titer
Interval 370.8 to 843.4
|
735.0 Geometric mean titer
Interval 503.6 to 1072.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 240Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Geometric Mean Fold Rise was reported as a ratio to Day 1.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=21 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=19 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=20 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By HAI Assay at Day 240
|
1.1 Ratio
Interval 0.9 to 1.2
|
1.6 Ratio
Interval 1.1 to 2.2
|
1.5 Ratio
Interval 1.1 to 2.1
|
1.7 Ratio
Interval 1.1 to 2.8
|
2.0 Ratio
Interval 1.3 to 3.0
|
3.2 Ratio
Interval 1.9 to 5.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 240Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Geometric Mean Fold Rise was reported as a ratio to Day 1.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=21 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=19 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=20 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise of Antibody Response to NA Glycoprotein Measured By ELLA at Day 240
|
5.5 Ratio
Interval 4.1 to 7.3
|
10.8 Ratio
Interval 6.7 to 17.3
|
13.8 Ratio
Interval 9.3 to 20.5
|
8.7 Ratio
Interval 5.3 to 14.1
|
14.1 Ratio
Interval 8.1 to 24.5
|
22.9 Ratio
Interval 13.5 to 38.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 240Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Seroconversion was recorded if participant had pre-vaccination antibody titer \< LLOQ and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=21 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=19 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=20 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By HAI Assay At Day 240
|
0.0 Percentage of Participants
Interval 0.0 to 14.3
|
9.5 Percentage of Participants
Interval 1.2 to 30.4
|
9.1 Percentage of Participants
Interval 1.1 to 29.2
|
10.5 Percentage of Participants
Interval 1.3 to 33.1
|
20.0 Percentage of Participants
Interval 5.7 to 43.7
|
33.3 Percentage of Participants
Interval 13.3 to 59.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 240Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. Seroconversion was recorded if participant had pre-vaccination antibody titer \< LLOQ and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=21 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=19 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=20 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion of Antibody Response to NA Glycoprotein Measured By ELLA At Day 240
|
70.8 Percentage of Participants
Interval 48.9 to 87.4
|
76.2 Percentage of Participants
Interval 52.8 to 91.8
|
91.3 Percentage of Participants
Interval 72.0 to 98.9
|
79.0 Percentage of Participants
Interval 54.4 to 94.0
|
80.0 Percentage of Participants
Interval 56.3 to 94.3
|
100.0 Percentage of Participants
Interval 81.5 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 240Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure.
A serum HAI assay was used for measuring HA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=21 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=19 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=20 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With HAI Titers Above Or Equal To Prespecified Thresholds At Day 240
≥1:10
|
4.2 Percentage of Participants
|
33.3 Percentage of Participants
|
30.4 Percentage of Participants
|
47.4 Percentage of Participants
|
40.0 Percentage of Participants
|
77.8 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With HAI Titers Above Or Equal To Prespecified Thresholds At Day 240
≥1:20
|
4.2 Percentage of Participants
|
23.8 Percentage of Participants
|
26.1 Percentage of Participants
|
36.8 Percentage of Participants
|
40.0 Percentage of Participants
|
72.2 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With HAI Titers Above Or Equal To Prespecified Thresholds At Day 240
≥1:40
|
0.0 Percentage of Participants
|
9.5 Percentage of Participants
|
8.7 Percentage of Participants
|
10.5 Percentage of Participants
|
20.0 Percentage of Participants
|
33.3 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With HAI Titers Above Or Equal To Prespecified Thresholds At Day 240
≥1:80
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With HAI Titers Above Or Equal To Prespecified Thresholds At Day 240
≥1:160
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With HAI Titers Above Or Equal To Prespecified Thresholds At Day 240
≥1:320
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 240Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure.
A serum ELLA assay was used for measuring NA-specific antibodies against the A/H5N1/Indonesia/5/2005 influenza strain. The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=21 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=19 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=20 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ELLA Titers Above Or Equal to Prespecified Thresholds At Day 240
≥1:10
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With ELLA Titers Above Or Equal to Prespecified Thresholds At Day 240
≥1:20
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With ELLA Titers Above Or Equal to Prespecified Thresholds At Day 240
≥1:40
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With ELLA Titers Above Or Equal to Prespecified Thresholds At Day 240
≥1:80
|
91.7 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
89.5 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With ELLA Titers Above Or Equal to Prespecified Thresholds At Day 240
≥1:160
|
79.2 Percentage of Participants
|
90.5 Percentage of Participants
|
82.6 Percentage of Participants
|
73.7 Percentage of Participants
|
90.0 Percentage of Participants
|
94.4 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With ELLA Titers Above Or Equal to Prespecified Thresholds At Day 240
≥1:320
|
41.7 Percentage of Participants
|
61.9 Percentage of Participants
|
60.9 Percentage of Participants
|
52.6 Percentage of Participants
|
75.0 Percentage of Participants
|
88.9 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: D1,29 Cohorts: Day 1, Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 1, Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
Neutralizing antibody response to H5 hemagglutinin was measured by MN assay. Antibody titers were expressed as Geometric Mean Titers.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer of Antibody Response Against HA Glycoprotein Measured By Microneutralization (MN) Assay
Day 1
|
43.7 Titer
Interval 28.3 to 67.6
|
49.7 Titer
Interval 34.1 to 72.5
|
40.1 Titer
Interval 24.4 to 65.9
|
40.8 Titer
Interval 27.1 to 61.4
|
50.2 Titer
Interval 32.1 to 78.5
|
49.7 Titer
Interval 31.0 to 79.6
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response Against HA Glycoprotein Measured By Microneutralization (MN) Assay
28 days post dose 1
|
287.0 Titer
Interval 201.7 to 408.4
|
404.4 Titer
Interval 302.9 to 539.9
|
460.0 Titer
Interval 343.4 to 616.1
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response Against HA Glycoprotein Measured By Microneutralization (MN) Assay
56 days post dose 1
|
—
|
—
|
—
|
278.7 Titer
Interval 202.8 to 383.2
|
377.8 Titer
Interval 286.7 to 497.8
|
439.5 Titer
Interval 337.7 to 571.9
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response Against HA Glycoprotein Measured By Microneutralization (MN) Assay
7 days post dose 2
|
367.0 Titer
Interval 244.2 to 551.5
|
650.3 Titer
Interval 465.4 to 908.7
|
859.1 Titer
Interval 683.7 to 1079.3
|
703.1 Titer
Interval 496.0 to 996.5
|
1039.6 Titer
Interval 755.4 to 1430.8
|
1730.0 Titer
Interval 1357.1 to 2205.4
|
—
|
—
|
|
Geometric Mean Titer of Antibody Response Against HA Glycoprotein Measured By Microneutralization (MN) Assay
28 days post dose 2
|
454.0 Titer
Interval 303.3 to 679.8
|
837.4 Titer
Interval 546.1 to 1072.1
|
981.3 Titer
Interval 753.1 to 1278.6
|
954.5 Titer
Interval 655.1 to 1390.8
|
1494.2 Titer
Interval 1088.1 to 2051.8
|
1884.5 Titer
Interval 470.9 to 2414.3
|
—
|
—
|
SECONDARY outcome
Timeframe: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
Neutralizing antibody response to H5 hemagglutinin was measured by MN assay. Geometric Mean Fold Rise was reported as a ratio to Day 1.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By MN Assay
28 days post dose 1
|
6.5 Ratio
Interval 4.9 to 8.6
|
8.1 Ratio
Interval 6.0 to 10.9
|
11.5 Ratio
Interval 7.2 to 18.4
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By MN Assay
56 days post dose 1
|
—
|
—
|
—
|
6.8 Ratio
Interval 4.3 to 10.8
|
7.5 Ratio
Interval 5.1 to 11.1
|
8.8 Ratio
Interval 5.9 to 13.3
|
—
|
—
|
|
Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By MN Assay
7 days post dose 2
|
8.3 Ratio
Interval 5.8 to 11.8
|
13.1 Ratio
Interval 8.8 to 19.5
|
19.2 Ratio
Interval 12.7 to 29.2
|
17.2 Ratio
Interval 10.0 to 29.8
|
20.7 Ratio
Interval 12.4 to 34.6
|
34.8 Ratio
Interval 20.9 to 58.2
|
—
|
—
|
|
Geometric Mean Fold Rise of Antibody Response to HA Glycoprotein Measured By MN Assay
28 days post dose 2
|
10.4 Ratio
Interval 6.9 to 15.5
|
16.8 Ratio
Interval 11.7 to 24.3
|
24.8 Ratio
Interval 14.8 to 41.4
|
23.4 Ratio
Interval 13.6 to 40.2
|
26.7 Ratio
Interval 17.0 to 41.9
|
41.2 Ratio
Interval 22.9 to 74.1
|
—
|
—
|
SECONDARY outcome
Timeframe: D1,29 Cohorts: Day 29 (28 days post dose 1), Day 36 (7 days post dose 2), and Day 57 (28 days post dose 2), D1,57 Cohorts: Day 57 (56 days post dose 1), Day 64 (7 days post dose 2), and Day 85 (28 days post dose 2)Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
Neutralizing antibody response to H5 hemagglutinin was measured by MN assay. Seroconversion was recorded if participant had pre-vaccination antibody titer \< LLOQ and a post-vaccination antibody titer ≥ 4 x LLOQ, or a pre-vaccination antibody titer ≥LLOQ and a ≥4-fold increase in post-vaccination antibody titer.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=18 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By MN Assay
28 days post dose 1
|
78.3 Percentage of Participants
Interval 56.3 to 92.5
|
85.7 Percentage of Participants
Interval 63.7 to 97.0
|
87.0 Percentage of Participants
Interval 66.4 to 97.2
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By MN Assay
56 days post dose 1
|
—
|
—
|
—
|
55.0 Percentage of Participants
Interval 31.5 to 76.9
|
72.7 Percentage of Participants
Interval 49.8 to 89.3
|
83.3 Percentage of Participants
Interval 58.6 to 96.4
|
—
|
—
|
|
Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By MN Assay
7 days post dose 2
|
82.6 Percentage of Participants
Interval 61.2 to 95.1
|
90.9 Percentage of Participants
Interval 70.8 to 98.9
|
90.9 Percentage of Participants
Interval 70.8 to 98.9
|
85.0 Percentage of Participants
Interval 62.1 to 96.8
|
86.4 Percentage of Participants
Interval 65.1 to 97.1
|
94.4 Percentage of Participants
Interval 72.7 to 99.9
|
—
|
—
|
|
Percentage of Participants With Seroconversion of Antibody Response to HA Glycoprotein Measured By MN Assay
28 days post dose 2
|
87.5 Percentage of Participants
Interval 67.6 to 97.3
|
95.5 Percentage of Participants
Interval 77.2 to 99.9
|
100.0 Percentage of Participants
Interval 84.6 to 100.0
|
95.0 Percentage of Participants
Interval 75.1 to 99.9
|
100.0 Percentage of Participants
Interval 83.9 to 100.0
|
94.1 Percentage of Participants
Interval 71.3 to 99.9
|
—
|
—
|
SECONDARY outcome
Timeframe: D1,29 Cohorts: Day 57 (28 days post dose 2), D1,57 Cohorts: Day 85 (28 days post dose 2)Population: PPS included all participants who received 1 dose of trial vaccine, provided at least 1 post-baseline immunogenicity assessment, correctly received the assigned dose of trial vaccine and had no protocol deviations impacting immunogenicity data. As prespecified, this analysis was not conducted for the control/placebo group. Overall number of participants analyzed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at each timepoint.
Neutralizing antibody response to H5 hemagglutinin was measured by MN assay. The prespecified antibody threshold levels were as follows: ≥1:10, ≥1:20, ≥1:40, ≥1:80, ≥1:160, and ≥1:320.
Outcome measures
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=24 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=22 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=23 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=20 Participants
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=21 Participants
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=17 Participants
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With MN Titers Above Or Equal To Prespecified Thresholds
≥1:320
|
62.5 Percentage of Participants
|
95.5 Percentage of Participants
|
95.7 Percentage of Participants
|
85.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With MN Titers Above Or Equal To Prespecified Thresholds
≥1:40
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With MN Titers Above Or Equal To Prespecified Thresholds
≥1:10
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With MN Titers Above Or Equal To Prespecified Thresholds
≥1:20
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With MN Titers Above Or Equal To Prespecified Thresholds
≥1:80
|
91.7 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
|
Percentage of Participants With MN Titers Above Or Equal To Prespecified Thresholds
≥1:160
|
87.5 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
—
|
—
|
Adverse Events
D1,29 Cohort: ARCT-2304 1.5 µg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
D1,29 Cohort: ARCT-2304 5 µg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
D1,29 Cohort: ARCT-2304 12 µg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
D1,29 Cohort: Control/Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
D1,57 Cohort: ARCT-2304 1.5µg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
D1,57 Cohort: ARCT-2304 5 µg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
D1,57 Cohort: ARCT-2304 12 µg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
D1,57 Cohort: Control/Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=26 participants at risk
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=26 participants at risk
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=27 participants at risk
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: Control/Placebo
n=27 participants at risk
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=27 participants at risk
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=27 participants at risk
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=26 participants at risk
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
n=26 participants at risk
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
3.8%
1/26 • Number of events 1 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Eye disorders
Diplopia
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
3.7%
1/27 • Number of events 1 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
3.8%
1/26 • Number of events 1 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
3.8%
1/26 • Number of events 1 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
3.8%
1/26 • Number of events 1 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
Other adverse events
| Measure |
D1,29 Cohort: ARCT-2304 1.5 µg
n=26 participants at risk
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 5 µg
n=26 participants at risk
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: ARCT-2304 12 µg
n=27 participants at risk
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 29.
|
D1,29 Cohort: Control/Placebo
n=27 participants at risk
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 29.
|
D1,57 Cohort: ARCT-2304 1.5µg
n=27 participants at risk
Participants received 1.5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 5 µg
n=27 participants at risk
Participants received 5 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: ARCT-2304 12 µg
n=26 participants at risk
Participants received 12 µg ARCT-2304 IM on Day 1 and Day 57.
|
D1,57 Cohort: Control/Placebo
n=26 participants at risk
Participants received an age-appropriate licensed influenza vaccine IM as the Control on Day 1, followed by Placebo IM on Day 57.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
7.4%
2/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Infections and infestations
Nasopharyngitis
|
7.7%
2/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Infections and infestations
Pharyngitis
|
7.7%
2/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
7.4%
2/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
7.7%
2/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
7.7%
2/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Investigations
Prothrombin time prolonged
|
11.5%
3/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
7.7%
2/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
7.4%
2/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Psychiatric disorders
Depression
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
7.4%
2/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
7.7%
2/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
7.4%
2/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/27 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
7.7%
2/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
0.00%
0/26 • Day 1 to Day 240
SAF included all participants who received at least one dose of trial vaccine and had any evaluable post-vaccination reactogenicity and/or safety data.
|
Additional Information
Arcturus Therapeutics, Inc.
Arcturus Therapeutics, Inc.
Phone: 858-900-2660
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The results of this study may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.
- Publication restrictions are in place
Restriction type: OTHER