Trial Outcomes & Findings for Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older (NCT NCT05608005)
NCT ID: NCT05608005
Last Updated: 2025-09-24
Results Overview
The HAI antibody was measured by hemagglutination inhibition using horse red blood cells (HIH) measurement method. The 95% confidence interval (CI) was based on the Student t-distribution of log10-transformed values.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
581 participants
Primary outcome timeframe
Day 22
Results posted on
2025-09-24
Participant Flow
The study was conducted at 16 centers in the United States between 03 November 2022 and 13 February 2024.
A total of 581 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
Participants received panblok H7 7.5 microgram (mcg) + MF59 adjuvant intramuscular (IM) injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Overall Study
STARTED
|
248
|
249
|
84
|
|
Overall Study
Vaccinated
|
243
|
246
|
84
|
|
Overall Study
COMPLETED
|
203
|
199
|
62
|
|
Overall Study
NOT COMPLETED
|
45
|
50
|
22
|
Reasons for withdrawal
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
Participants received panblok H7 7.5 microgram (mcg) + MF59 adjuvant intramuscular (IM) injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
3
|
|
Overall Study
Protocol Violation
|
2
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
10
|
12
|
4
|
|
Overall Study
Lost to Follow-up
|
25
|
27
|
15
|
|
Overall Study
Participants were not vaccinated or withdrew for other reasons
|
6
|
7
|
0
|
Baseline Characteristics
Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older
Baseline characteristics by cohort
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=243 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=246 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=84 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
Total
n=573 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 15.2 • n=99 Participants
|
56.2 years
STANDARD_DEVIATION 15.3 • n=107 Participants
|
54.7 years
STANDARD_DEVIATION 17.1 • n=206 Participants
|
56.2 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
299 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=99 Participants
|
121 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
274 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
67 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
146 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
168 Participants
n=99 Participants
|
173 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
408 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Multiple origin
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 22Population: The Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.
The HAI antibody was measured by hemagglutination inhibition using horse red blood cells (HIH) measurement method. The 95% confidence interval (CI) was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=231 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=232 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22
|
5.74 titer
Interval 5.44 to 6.06
|
5.61 titer
Interval 5.34 to 5.9
|
5.28 titer
Interval 5.1 to 5.47
|
PRIMARY outcome
Timeframe: Day 43Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.
The HAI antibody was measured by HIH measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=224 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=231 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=72 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43
|
12.6 titer
Interval 10.8 to 14.6
|
13.4 titer
Interval 11.6 to 15.5
|
5.80 titer
Interval 5.37 to 6.27
|
PRIMARY outcome
Timeframe: Days 1 and 22Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 22 are reported.
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=230 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=232 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22
|
1.09 ratio
Interval 1.03 to 1.15
|
1.05 ratio
Interval 0.998 to 1.11
|
1.03 ratio
Interval 0.981 to 1.08
|
PRIMARY outcome
Timeframe: Days 1 and 43Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 43 are reported.
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=223 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=231 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=72 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43
|
2.39 ratio
Interval 2.05 to 2.78
|
2.52 ratio
Interval 2.17 to 2.91
|
1.13 ratio
Interval 1.05 to 1.23
|
PRIMARY outcome
Timeframe: Days 1 and 202Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 202 are reported.
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=209 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=212 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=66 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202
|
1.01 ratio
Interval 0.969 to 1.05
|
0.966 ratio
Interval 0.92 to 1.01
|
0.990 ratio
Interval 0.951 to 1.03
|
PRIMARY outcome
Timeframe: Days 1 and 387Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 387 are reported.
The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=202 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=198 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=61 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387
|
0.998 ratio
Interval 0.961 to 1.04
|
0.976 ratio
Interval 0.927 to 1.03
|
0.978 ratio
Interval 0.943 to 1.01
|
PRIMARY outcome
Timeframe: Day 22Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.
The seroconversion was defined as titer \<10 on Day 1 and post-injection titer \>=40 on Day 22 or Day 43; or defined as titer \>=10 on Day 1 and a \>=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=230 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=232 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22
|
2.2 percentage of participants
Interval 0.7 to 5.0
|
0.4 percentage of participants
Interval 0.0 to 2.4
|
0.0 percentage of participants
Interval 0.0 to 4.7
|
PRIMARY outcome
Timeframe: Day 43Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.
The seroconversion was defined as titer \<10 on Day 1 and post-injection titer \>=40 on Day 22 or Day 43; or defined as titer \>=10 on Day 1 and a \>=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=223 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=231 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=72 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43
|
22.9 percentage of participants
Interval 17.5 to 28.9
|
22.9 percentage of participants
Interval 17.7 to 28.9
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
PRIMARY outcome
Timeframe: Day 1Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 1 are reported.
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=233 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=233 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1
|
0.0 percentage of participants
Interval 0.0 to 1.6
|
0.9 percentage of participants
Interval 0.1 to 3.1
|
0.0 percentage of participants
Interval 0.0 to 4.7
|
PRIMARY outcome
Timeframe: Day 22Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=231 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=232 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22
|
2.2 percentage of participants
Interval 0.7 to 5.0
|
0.9 percentage of participants
Interval 0.1 to 3.1
|
0.0 percentage of participants
Interval 0.0 to 4.7
|
PRIMARY outcome
Timeframe: Day 43Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=224 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=231 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=72 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43
|
23.2 percentage of participants
Interval 17.9 to 29.3
|
23.4 percentage of participants
Interval 18.1 to 29.4
|
1.4 percentage of participants
Interval 0.0 to 7.5
|
PRIMARY outcome
Timeframe: Day 202Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 202 are reported.
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=210 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=212 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=66 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202
|
0.5 percentage of participants
Interval 0.0 to 2.6
|
0.0 percentage of participants
Interval 0.0 to 1.7
|
0.0 percentage of participants
Interval 0.0 to 5.4
|
PRIMARY outcome
Timeframe: Day 387Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 387 are reported.
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=203 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=198 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=61 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387
|
0.0 percentage of participants
Interval 0.0 to 1.8
|
0.0 percentage of participants
Interval 0.0 to 1.8
|
0.0 percentage of participants
Interval 0.0 to 5.9
|
PRIMARY outcome
Timeframe: Day 1Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 1 are reported.
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=233 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=233 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1
|
3.4 percentage of participants
Interval 1.5 to 6.7
|
3.4 percentage of participants
Interval 1.5 to 6.7
|
1.3 percentage of participants
Interval 0.0 to 7.1
|
PRIMARY outcome
Timeframe: Day 22Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=231 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=232 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22
|
6.9 percentage of participants
Interval 4.0 to 11.0
|
6.5 percentage of participants
Interval 3.7 to 10.4
|
2.6 percentage of participants
Interval 0.3 to 9.2
|
PRIMARY outcome
Timeframe: Day 43Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=224 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=231 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=72 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43
|
46.9 percentage of participants
Interval 40.2 to 53.6
|
52.4 percentage of participants
Interval 45.7 to 59.0
|
9.7 percentage of participants
Interval 4.0 to 19.0
|
PRIMARY outcome
Timeframe: Day 202Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 202 are reported.
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=210 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=212 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=66 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202
|
3.3 percentage of participants
Interval 1.4 to 6.7
|
2.4 percentage of participants
Interval 0.8 to 5.4
|
1.5 percentage of participants
Interval 0.0 to 8.2
|
PRIMARY outcome
Timeframe: Day 387Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 387 are reported.
The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=203 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=198 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=61 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387
|
3.0 percentage of participants
Interval 1.1 to 6.3
|
2.5 percentage of participants
Interval 0.8 to 5.8
|
0.0 percentage of participants
Interval 0.0 to 5.9
|
PRIMARY outcome
Timeframe: Day 22Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.
The NT antibody was measured by seroneutralization (SN) measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=231 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=232 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22
|
7.23 titer
Interval 6.61 to 7.91
|
6.85 titer
Interval 6.31 to 7.45
|
6.88 titer
Interval 6.04 to 7.84
|
PRIMARY outcome
Timeframe: Day 43Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.
The NT antibody was measured by SN measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=224 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=231 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=72 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean of Neutralization Test Antibody Titer at Day 43
|
26.8 titer
Interval 22.0 to 32.6
|
25.8 titer
Interval 21.9 to 30.4
|
11.5 titer
Interval 9.31 to 14.1
|
PRIMARY outcome
Timeframe: Days 1 and 22Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 22 are reported.
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=230 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=232 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22
|
1.21 ratio
Interval 1.09 to 1.35
|
1.14 ratio
Interval 1.04 to 1.25
|
1.09 ratio
Interval 0.923 to 1.28
|
PRIMARY outcome
Timeframe: Days 1 and 43Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 43 are reported.
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=223 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=231 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=72 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43
|
4.51 ratio
Interval 3.66 to 5.55
|
4.29 ratio
Interval 3.59 to 5.14
|
1.86 ratio
Interval 1.46 to 2.38
|
PRIMARY outcome
Timeframe: Days 1 and 202Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 202 are reported.
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=209 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=212 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=66 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202
|
1.20 ratio
Interval 1.07 to 1.34
|
1.17 ratio
Interval 1.05 to 1.3
|
0.856 ratio
Interval 0.735 to 0.997
|
PRIMARY outcome
Timeframe: Days 1 and 387Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Days 1 and 387 are reported.
The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=202 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=198 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=61 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387
|
1.20 ratio
Interval 1.07 to 1.35
|
1.18 ratio
Interval 1.06 to 1.32
|
0.909 ratio
Interval 0.792 to 1.04
|
PRIMARY outcome
Timeframe: Day 22Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=231 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=232 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22
Antibody Titer >=1:20
|
10.0 percentage of participants
Interval 6.4 to 14.6
|
7.3 percentage of participants
Interval 4.3 to 11.5
|
7.9 percentage of participants
Interval 3.0 to 16.4
|
|
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22
Antibody Titer >=1:40
|
2.2 percentage of participants
Interval 0.7 to 5.0
|
2.2 percentage of participants
Interval 0.7 to 5.0
|
0.0 percentage of participants
Interval 0.0 to 4.7
|
|
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22
Antibody Titer >=1:80
|
1.3 percentage of participants
Interval 0.3 to 3.7
|
0.9 percentage of participants
Interval 0.1 to 3.1
|
0.0 percentage of participants
Interval 0.0 to 4.7
|
PRIMARY outcome
Timeframe: Day 43Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=224 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=231 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=72 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43
Antibody Titer >=1:20
|
54.9 percentage of participants
Interval 48.1 to 61.5
|
55.8 percentage of participants
Interval 49.2 to 62.4
|
29.2 percentage of participants
Interval 19.0 to 41.1
|
|
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43
Antibody Titer >=1:40
|
35.7 percentage of participants
Interval 29.4 to 42.4
|
35.1 percentage of participants
Interval 28.9 to 41.6
|
11.1 percentage of participants
Interval 4.9 to 20.7
|
|
Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43
Antibody Titer >=1:80
|
22.3 percentage of participants
Interval 17.0 to 28.3
|
16.0 percentage of participants
Interval 11.5 to 21.4
|
2.8 percentage of participants
Interval 0.3 to 9.7
|
PRIMARY outcome
Timeframe: Day 22Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=230 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=232 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22
>=2 fold increase
|
22.2 percentage of participants
Interval 17.0 to 28.1
|
17.2 percentage of participants
Interval 12.6 to 22.7
|
18.4 percentage of participants
Interval 10.5 to 29.0
|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22
>=4 fold increase
|
7.8 percentage of participants
Interval 4.7 to 12.1
|
6.0 percentage of participants
Interval 3.3 to 9.9
|
5.3 percentage of participants
Interval 1.5 to 12.9
|
PRIMARY outcome
Timeframe: Day 43Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=223 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=231 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=72 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43
>=2 fold increase
|
64.6 percentage of participants
Interval 57.9 to 70.8
|
71.4 percentage of participants
Interval 65.1 to 77.2
|
48.6 percentage of participants
Interval 36.7 to 60.7
|
|
Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43
>=4 fold increase
|
51.1 percentage of participants
Interval 44.4 to 57.9
|
51.9 percentage of participants
Interval 45.3 to 58.5
|
26.4 percentage of participants
Interval 16.7 to 38.1
|
PRIMARY outcome
Timeframe: Day 1Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 1 are reported.
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=233 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=233 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1
|
14.2 percentage of participants
Interval 10.0 to 19.3
|
15.5 percentage of participants
Interval 11.1 to 20.7
|
18.4 percentage of participants
Interval 10.5 to 29.0
|
PRIMARY outcome
Timeframe: Day 22Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 22 are reported.
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=231 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=232 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=76 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22
|
26.8 percentage of participants
Interval 21.2 to 33.0
|
24.1 percentage of participants
Interval 18.8 to 30.2
|
26.3 percentage of participants
Interval 16.9 to 37.7
|
PRIMARY outcome
Timeframe: Day 43Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 43 are reported.
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=224 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=231 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=72 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43
|
69.6 percentage of participants
Interval 63.2 to 75.6
|
76.2 percentage of participants
Interval 70.2 to 81.5
|
54.2 percentage of participants
Interval 42.0 to 66.0
|
PRIMARY outcome
Timeframe: Day 202Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 202 are reported.
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=210 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=212 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=66 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202
|
25.7 percentage of participants
Interval 19.9 to 32.2
|
25.0 percentage of participants
Interval 19.3 to 31.4
|
6.1 percentage of participants
Interval 1.7 to 14.8
|
PRIMARY outcome
Timeframe: Day 387Population: The FAS included all randomized participants who received at least 1 dose of the study vaccine and had a post-vaccination blood sample for Day 22 or Day 43. Only participants analyzed at Day 387 are reported.
The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=203 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=198 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=61 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387
|
24.1 percentage of participants
Interval 18.4 to 30.6
|
26.3 percentage of participants
Interval 20.3 to 33.0
|
8.2 percentage of participants
Interval 2.7 to 18.1
|
SECONDARY outcome
Timeframe: Up to 30 minutes after each vaccinationPopulation: The Safety analysis set included all participants who had received at least 1 study vaccine.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination. Systemic AEs are all AEs that were not injection or administration site reactions. Immediate events are recorded to capture medically relevant unsolicited systemic AEs which occur within the first 30 minutes after vaccination.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=243 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=246 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=84 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days after each vaccinationPopulation: The Safety analysis set included all participants who had received at least 1 study vaccine. Only participants analyzed for specific parameter are reported.
An adverse reaction (AR) is any noxious and unintended response to a study vaccine related to any dose. A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and case report form. An injection/administration site reaction is an AR at and around the injection/administration site of the investigational medical product. Systemic ARs are all ARs that are not injection or administration site reactions.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=242 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=244 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=83 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Solicited injection site reaction
|
53 Participants
|
57 Participants
|
8 Participants
|
|
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Solicited systemic reaction
|
57 Participants
|
56 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to 21 days after each vaccinationPopulation: The Safety analysis set included all participants who had received at least 1 study vaccine.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions, that is, pre-listed in the case report form in terms of diagnosis and onset window post-vaccination.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=243 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=246 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=84 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Number of Participants With Unsolicited AEs
|
32 Participants
|
39 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From first dose vaccine administration (Day 1) until 12 months after the last dose administration, 387 daysPopulation: The Safety analysis set included all participants who had received at least 1 study vaccine.
An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. An AESI (serious or non-serious) is one of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. An MAAE is a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or Emergency Department.
Outcome measures
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=243 Participants
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=246 Participants
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=84 Participants
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
Any SAE
|
11 Participants
|
12 Participants
|
6 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
Any AESI
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Adverse Event of Special Interest (AESIs) and Medically Attended Adverse Events (MAAEs)
Any MAAE
|
41 Participants
|
42 Participants
|
10 Participants
|
Adverse Events
Group 1: Panblok H7 (7.5 mcg) + MF59
Serious events: 11 serious events
Other events: 82 other events
Deaths: 1 deaths
Group 2: Panblok H7 (15 mcg) + MF59
Serious events: 12 serious events
Other events: 82 other events
Deaths: 1 deaths
Group 3: Panblok H7 (45 mcg) Unadjuvanted
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=243 participants at risk
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=246 participants at risk
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=84 participants at risk
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Cardiac disorders
Atrial Flutter
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
1.2%
1/84 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Cardiac disorders
Stress Cardiomyopathy
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
General disorders
Death
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
General disorders
Oedema
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Infections and infestations
Diverticulitis
|
0.82%
2/243 • Number of events 2 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Infections and infestations
Fournier's Gangrene
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 2 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
1.2%
1/84 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Infections and infestations
Pneumonia
|
0.82%
2/243 • Number of events 2 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 2 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Infections and infestations
Salmonellosis
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Infections and infestations
Sepsis
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
1.2%
1/84 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Injury, poisoning and procedural complications
Bone Contusion
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Injury, poisoning and procedural complications
Fractured Coccyx
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
1.2%
1/84 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac Myxoma
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac Valve Fibroelastoma
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fallopian Tube Cancer
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
1.2%
1/84 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
1.2%
1/84 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Nervous system disorders
Embolic Cerebral Infarction
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Nervous system disorders
Paraesthesia
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.81%
2/246 • Number of events 2 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/243 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.41%
1/246 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Vascular disorders
Giant Cell Arteritis
|
0.41%
1/243 • Number of events 1 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/246 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
0.00%
0/84 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
Other adverse events
| Measure |
Group 1: Panblok H7 (7.5 mcg) + MF59
n=243 participants at risk
Participants received panblok H7 7.5 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 2: Panblok H7 (15 mcg) + MF59
n=246 participants at risk
Participants received panblok H7 15 mcg + MF59 adjuvant IM injection once daily on Days 1 and 22.
|
Group 3: Panblok H7 (45 mcg) Unadjuvanted
n=84 participants at risk
Participants received panblok H7 45 mcg unadjuvanted IM injection once daily on Days 1 and 22.
|
|---|---|---|---|
|
General disorders
Injection Site Pain
|
21.8%
53/243 • Number of events 66 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
20.7%
51/246 • Number of events 60 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
8.3%
7/84 • Number of events 8 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
General disorders
Malaise
|
13.6%
33/243 • Number of events 40 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
12.2%
30/246 • Number of events 33 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
17.9%
15/84 • Number of events 16 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.7%
9/243 • Number of events 9 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
3.7%
9/246 • Number of events 10 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
6.0%
5/84 • Number of events 5 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.2%
32/243 • Number of events 43 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
15.0%
37/246 • Number of events 41 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
13.1%
11/84 • Number of events 13 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
|
Nervous system disorders
Headache
|
14.8%
36/243 • Number of events 44 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
13.4%
33/246 • Number of events 41 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
14.3%
12/84 • Number of events 14 • From first dose vaccine administration (Day 1) up to 12 months after the last dose administration, maximum of 387 days
The Safety analysis set included all participants who had received at least 1 study vaccine.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER