Trial Outcomes & Findings for Panblok H7 Vaccine Adjuvanted With AS03 or MF59 (NCT NCT03283319)
NCT ID: NCT03283319
Last Updated: 2020-05-06
Results Overview
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain
COMPLETED
PHASE2
366 participants
Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
2020-05-06
Participant Flow
Participant milestones
| Measure |
3.75 µg Panblok H7 Plus AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
3.75 µg Panblok H7 Plus MF59
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus MF59
|
7.5 µg Panblok H7 Plus MF59
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus MF59
|
15 µg Panblok H7 Plus MF59
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus MF59
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
60
|
62
|
61
|
60
|
61
|
|
Overall Study
COMPLETED
|
55
|
54
|
55
|
54
|
56
|
57
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
7
|
7
|
4
|
4
|
Reasons for withdrawal
| Measure |
3.75 µg Panblok H7 Plus AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
3.75 µg Panblok H7 Plus MF59
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus MF59
|
7.5 µg Panblok H7 Plus MF59
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus MF59
|
15 µg Panblok H7 Plus MF59
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus MF59
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
5
|
5
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
1
|
0
|
1
|
|
Overall Study
BARDA regulatory agency or IRB decision
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Panblok H7 Vaccine Adjuvanted With AS03 or MF59
Baseline characteristics by cohort
| Measure |
3.75 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
3.75 µg Panblok H7 Plus MF59
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus MF59
|
7.5 µg Panblok H7 Plus MF59
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus MF59
|
15 µg Panblok H7 Plus MF59
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus MF59
|
Total
n=366 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
60 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
61 Participants
n=30 Participants
|
363 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Age, Continuous
|
34.8 years
STANDARD_DEVIATION 7.92 • n=99 Participants
|
34.3 years
STANDARD_DEVIATION 9.14 • n=107 Participants
|
35.8 years
STANDARD_DEVIATION 9.29 • n=206 Participants
|
35 years
STANDARD_DEVIATION 9.58 • n=7 Participants
|
37.1 years
STANDARD_DEVIATION 7.66 • n=31 Participants
|
35.8 years
STANDARD_DEVIATION 8.53 • n=30 Participants
|
35.4 years
STANDARD_DEVIATION 8.65 • n=3 Participants
|
|
Sex/Gender, Customized
Female
|
32 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
37 Participants
n=31 Participants
|
35 Participants
n=30 Participants
|
202 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Male
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
26 Participants
n=30 Participants
|
164 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
22 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
60 Participants
n=7 Participants
|
58 Participants
n=31 Participants
|
57 Participants
n=30 Participants
|
344 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
60 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
51 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
53 Participants
n=30 Participants
|
291 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=99 Participants
|
60 participants
n=107 Participants
|
62 participants
n=206 Participants
|
61 participants
n=7 Participants
|
60 participants
n=31 Participants
|
61 participants
n=30 Participants
|
366 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)Population: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03
|
42 Participants
|
44 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)Population: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant AS03
|
25 Participants
|
28 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)Population: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant MF59
|
37 Participants
|
30 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)Population: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one of the following during at least one of the time frames specified: Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant MF59
|
27 Participants
|
24 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: Day 50Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
|
53 Participants
|
53 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: Day 50Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
|
47 Participants
|
47 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: Day 50Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
|
48 Participants
|
52 Participants
|
55 Participants
|
PRIMARY outcome
Timeframe: Day 50Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
|
37 Participants
|
35 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 394Population: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one serious adverse event
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant AS03
|
3 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 394Population: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one serious adverse event
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant MF59
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 394Population: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one adverse event that requires a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring post-vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant AS03
|
11 Participants
|
8 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 394Population: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one adverse event that requires a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring post-vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant MF59
|
9 Participants
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 394Population: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant AS03
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 394Population: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant MF59
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 53, which is the upper window of the Day 50 visitPopulation: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one unsolicited adverse event (i.e. adverse events not included in the solicited local and systemic adverse event list nor considered a serious AE, MAAE or PIMMC ) that occur post-vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=62 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant AS03
|
24 Participants
|
25 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 50Population: Safety population includes all participants who received any amount of study vaccination.
Count of participants who experienced at least one unsolicited adverse event (i.e. adverse events not included in the solicited local and systemic adverse event list nor considered a serious AE, MAAE or PIMMC) that occur post-vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=60 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=61 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant MF59
|
24 Participants
|
24 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Day 50Population: The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
|
55 Participants
|
55 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: Day 50Population: The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
|
38 Participants
|
36 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Day 50Population: The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
|
50 Participants
|
54 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Screening and Days 29, 50, 121 and 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Screening
|
5.1 Titers
Interval 5.0 to 5.2
|
5.3 Titers
Interval 5.0 to 5.7
|
5.5 Titers
Interval 5.1 to 5.9
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Visit 4/Day 29
|
8.7 Titers
Interval 7.0 to 10.8
|
12.3 Titers
Interval 9.4 to 16.0
|
12.4 Titers
Interval 9.2 to 16.8
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Visit 7/Day 50
|
297.1 Titers
Interval 216.5 to 407.7
|
438.3 Titers
Interval 329.4 to 583.0
|
505.9 Titers
Interval 399.7 to 640.2
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Visit 8/Day 121
|
58.8 Titers
Interval 43.9 to 78.8
|
73 Titers
Interval 55.5 to 96.0
|
90 Titers
Interval 70.2 to 115.3
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Visit 9/Day 212
|
21.2 Titers
Interval 15.6 to 28.8
|
21.6 Titers
Interval 16.2 to 28.7
|
26 Titers
Interval 18.9 to 35.7
|
SECONDARY outcome
Timeframe: Day 50Population: The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
|
48 Participants
|
48 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Days 29, 50, 121, and 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Visit 4/Day 29
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Visit 7/Day 50
|
51 Participants
|
50 Participants
|
54 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Visit 8/Day 121
|
34 Participants
|
40 Participants
|
44 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Visit 9/Day 212
|
22 Participants
|
25 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Screening and Days 29, 50, 121 and 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Screening
|
5.1 Titers
Interval 5.0 to 5.2
|
5.5 Titers
Interval 5.0 to 6.1
|
5.1 Titers
Interval 5.0 to 5.2
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Visit 4/Day 29
|
6.1 Titers
Interval 5.1 to 7.3
|
6.6 Titers
Interval 5.7 to 7.7
|
6.4 Titers
Interval 5.6 to 7.3
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Visit 7/Day 50
|
76.3 Titers
Interval 55.9 to 104.0
|
106.5 Titers
Interval 74.1 to 153.0
|
130.6 Titers
Interval 93.1 to 183.2
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Visit 8/Day 121
|
18.1 Titers
Interval 13.6 to 24.1
|
20.7 Titers
Interval 14.9 to 28.8
|
33.2 Titers
Interval 25.1 to 43.9
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Visit 9/Day 212
|
6.8 Titers
Interval 6.0 to 7.7
|
8.9 Titers
Interval 7.1 to 11.1
|
11.4 Titers
Interval 8.7 to 15.0
|
SECONDARY outcome
Timeframe: Day 50Population: The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
|
75.4 Titers
Interval 55.6 to 102.4
|
103 Titers
Interval 72.1 to 147.2
|
124.3 Titers
Interval 87.9 to 175.8
|
SECONDARY outcome
Timeframe: Screening and Days 29, 50, 121 and 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Screening
|
5 Titers
Interval 5.0 to 5.0
|
5.2 Titers
Interval 4.9 to 5.6
|
5.2 Titers
Interval 5.0 to 5.4
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Visit 4/Day 29
|
5.9 Titers
Interval 5.2 to 6.7
|
8.3 Titers
Interval 6.7 to 10.3
|
8.4 Titers
Interval 6.6 to 10.7
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Visit 7/Day 50
|
170.2 Titers
Interval 119.9 to 241.7
|
302 Titers
Interval 218.9 to 416.7
|
316.7 Titers
Interval 246.2 to 407.4
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Visit 8/Day 121
|
45.2 Titers
Interval 33.4 to 61.1
|
57.7 Titers
Interval 42.5 to 78.4
|
69.7 Titers
Interval 53.1 to 91.6
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Visit 9/Day 212
|
25 Titers
Interval 18.3 to 34.2
|
28.1 Titers
Interval 20.1 to 39.2
|
32.9 Titers
Interval 24.4 to 44.4
|
SECONDARY outcome
Timeframe: Day 50Population: The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
|
163.8 Titers
Interval 115.7 to 231.9
|
274.9 Titers
Interval 195.3 to 386.9
|
313.1 Titers
Interval 243.1 to 403.1
|
SECONDARY outcome
Timeframe: Screening and Days 29, 50, 121 and 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Screening
|
5.1 Titers
Interval 5.0 to 5.2
|
5.1 Titers
Interval 5.0 to 5.2
|
5.3 Titers
Interval 4.8 to 5.8
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Visit 4/Day 29
|
5.7 Titers
Interval 5.1 to 6.3
|
5.6 Titers
Interval 5.1 to 6.1
|
5.6 Titers
Interval 5.2 to 6.1
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Visit 7/Day 50
|
47.6 Titers
Interval 33.7 to 67.1
|
60.5 Titers
Interval 40.5 to 90.4
|
74.5 Titers
Interval 53.3 to 104.0
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Visit 8/Day 121
|
13 Titers
Interval 10.2 to 16.6
|
15.1 Titers
Interval 11.2 to 20.4
|
20.9 Titers
Interval 15.6 to 27.8
|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Visit 9/Day 212
|
7.8 Titers
Interval 6.7 to 9.1
|
11.3 Titers
Interval 8.6 to 14.8
|
13.6 Titers
Interval 10.1 to 18.2
|
SECONDARY outcome
Timeframe: Day 50Population: The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
|
47.4 Titers
Interval 33.8 to 66.5
|
58.6 Titers
Interval 39.4 to 87.2
|
71.1 Titers
Interval 50.6 to 100.0
|
SECONDARY outcome
Timeframe: Screening, Day 29, Day 121, Day 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Visit 4/Day 29
|
7 Participants
|
10 Participants
|
13 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Visit 8/Day 121
|
40 Participants
|
45 Participants
|
47 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Visit 9/Day 212
|
21 Participants
|
19 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Screening, Day 29, Day 121, Day 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Visit 4/Day 29
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Visit 8/Day 121
|
19 Participants
|
24 Participants
|
34 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Visit 9/Day 212
|
1 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Screening, Day 29, Day 121, Day 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Visit 4/Day 29
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Visit 8/Day 121
|
37 Participants
|
40 Participants
|
45 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Visit 9/Day 212
|
22 Participants
|
22 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Screening, Day 29, Day 121, Day 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer \>= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Screening
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Visit 4/Day 29
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Visit 8/Day 121
|
10 Participants
|
15 Participants
|
22 Participants
|
|
Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Visit 9/Day 212
|
1 Participants
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 29, Day 50, Day 121, Day 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Visit 4/Day 29
|
7 Participants
|
10 Participants
|
12 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Visit 7/Day 50
|
53 Participants
|
53 Participants
|
56 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Visit 8/Day 121
|
40 Participants
|
45 Participants
|
47 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03
Visit 9/Day 212
|
21 Participants
|
19 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Day 29, Day 50, Day 121, Day 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Visit 4/Day 29
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Visit 7/Day 50
|
47 Participants
|
47 Participants
|
48 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Visit 8/Day 121
|
19 Participants
|
23 Participants
|
34 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Visit 9/Day 212
|
1 Participants
|
4 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 29, Day 50, Day 121, Day 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Visit 4/Day 29
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Visit 7/Day 50
|
48 Participants
|
52 Participants
|
55 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Visit 8/Day 121
|
37 Participants
|
39 Participants
|
45 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Visit 9/Day 212
|
22 Participants
|
22 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Day 29, Day 50, Day 121, Day 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer \<1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Visit 4/Day 29
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Visit 7/Day 50
|
37 Participants
|
35 Participants
|
47 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Visit 8/Day 121
|
10 Participants
|
15 Participants
|
21 Participants
|
|
Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Visit 9/Day 212
|
1 Participants
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 29, Day 50, Day 121, Day 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Visit 4/Day 29
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Visit 7/Day 50
|
40 Participants
|
39 Participants
|
44 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Visit 8/Day 121
|
11 Participants
|
14 Participants
|
21 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59
Visit 9/Day 212
|
2 Participants
|
4 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 29, Day 50, Day 121, Day 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Visit 4/Day 29
|
0 Participants
|
2 Participants
|
7 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Visit 7/Day 50
|
53 Participants
|
53 Participants
|
56 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Visit 8/Day 121
|
38 Participants
|
43 Participants
|
47 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03
Visit 9/Day 212
|
25 Participants
|
28 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: Day 29, Day 50, Day 121, Day 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer \<1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Visit 4/Day 29
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Visit 7/Day 50
|
46 Participants
|
44 Participants
|
47 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Visit 8/Day 121
|
11 Participants
|
21 Participants
|
27 Participants
|
|
Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59
Visit 9/Day 212
|
3 Participants
|
6 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 50Population: The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=59 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
|
276.3 Titers
Interval 200.1 to 381.5
|
400.7 Titers
Interval 291.9 to 550.1
|
489.1 Titers
Interval 383.0 to 624.5
|
SECONDARY outcome
Timeframe: Screening and Days 29, 50, 121 and 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
Serum MN antibody titers against the H7 antigen (protein) contained in the vaccine. A higher MN titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Screening
|
5.0 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
|
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Visit 4/Day 29
|
5.3 Titers
Interval 5.0 to 5.5
|
6.2 Titers
Interval 5.6 to 6.9
|
6.3 Titers
Interval 5.5 to 7.2
|
|
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Visit 7/Day 50
|
201.2 Titers
Interval 147.4 to 274.6
|
274.3 Titers
Interval 197.4 to 381.2
|
286.3 Titers
Interval 218.1 to 375.7
|
|
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Visit 8/Day 121
|
51.4 Titers
Interval 40.8 to 64.7
|
58.1 Titers
Interval 44.6 to 75.6
|
66.6 Titers
Interval 53.4 to 83.1
|
|
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03
Visit 9/Day 212
|
29 Titers
Interval 22.2 to 38.0
|
29.7 Titers
Interval 22.7 to 38.8
|
34.4 Titers
Interval 27.6 to 42.9
|
SECONDARY outcome
Timeframe: Screening and Days 29, 50, 121 and 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Screening
|
5.1 Titers
Interval 5.0 to 5.1
|
5 Titers
Interval 5.0 to 5.1
|
5 Titers
Interval 5.0 to 5.0
|
|
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Visit 4/Day 29
|
5.2 Titers
Interval 4.9 to 5.5
|
5 Titers
Interval 5.0 to 5.1
|
5.2 Titers
Interval 4.9 to 5.4
|
|
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Visit 7/Day 50
|
53 Titers
Interval 39.9 to 70.3
|
67.1 Titers
Interval 46.3 to 97.1
|
81.9 Titers
Interval 60.1 to 111.7
|
|
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Visit 8/Day 121
|
15.1 Titers
Interval 12.2 to 18.8
|
18.5 Titers
Interval 14.5 to 23.5
|
25.6 Titers
Interval 19.7 to 33.1
|
|
Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59
Visit 9/Day 212
|
8.2 Titers
Interval 7.0 to 9.7
|
10.7 Titers
Interval 8.9 to 13.0
|
14 Titers
Interval 10.8 to 18.0
|
SECONDARY outcome
Timeframe: Screening and Days 29, 50, 121 and 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=54 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=56 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Screening
|
5 Titers
Interval 5.0 to 5.1
|
5 Titers
Interval 5.0 to 5.0
|
5.2 Titers
Interval 4.9 to 5.4
|
|
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Visit 4/Day 29
|
6.4 Titers
Interval 5.7 to 7.3
|
7.8 Titers
Interval 6.7 to 9.1
|
8.9 Titers
Interval 7.2 to 11.2
|
|
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Visit 7/Day 50
|
256.1 Titers
Interval 190.3 to 344.6
|
326.2 Titers
Interval 238.1 to 446.9
|
394.9 Titers
Interval 303.8 to 513.4
|
|
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Visit 8/Day 121
|
58.4 Titers
Interval 44.9 to 76.0
|
71.6 Titers
Interval 53.6 to 95.6
|
95.4 Titers
Interval 73.3 to 124.4
|
|
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03
Visit 9/Day 212
|
31.5 Titers
Interval 23.7 to 41.9
|
34.4 Titers
Interval 26.1 to 45.4
|
41.1 Titers
Interval 32.0 to 52.7
|
SECONDARY outcome
Timeframe: Screening and Days 29, 50, 121 and 212Population: Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments
Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.
Outcome measures
| Measure |
3.75 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 µg Panblok H7 plus AS03
|
7.5 µg Panblok H7 Plus AS03
n=57 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 µg Panblok H7 plus AS03
|
15 µg Panblok H7 Plus AS03
n=58 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 µg Panblok H7 plus AS03
|
|---|---|---|---|
|
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Visit 4/Day 29
|
5.8 Titers
Interval 5.2 to 6.5
|
6 Titers
Interval 5.3 to 6.7
|
5.9 Titers
Interval 5.4 to 6.4
|
|
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Screening
|
5.1 Titers
Interval 5.0 to 5.2
|
5.3 Titers
Interval 5.0 to 5.6
|
5.1 Titers
Interval 5.0 to 5.1
|
|
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Visit 7/Day 50
|
67.3 Titers
Interval 51.4 to 88.0
|
87.1 Titers
Interval 59.8 to 126.9
|
113.8 Titers
Interval 80.4 to 161.1
|
|
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Visit 8/Day 121
|
15.7 Titers
Interval 12.5 to 19.8
|
20 Titers
Interval 15.0 to 26.6
|
27.1 Titers
Interval 20.0 to 36.7
|
|
Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59
Visit 9/Day 212
|
8.7 Titers
Interval 7.3 to 10.5
|
11.5 Titers
Interval 9.2 to 14.4
|
15.2 Titers
Interval 11.6 to 19.9
|
Adverse Events
3.75 ug Panblok H7 Plus AS03
7.5 ug Panblok H7 Plus AS03
15 ug Panblok H7 Plus AS03
3.75 ug Panblok H7 Plus MF59
7.5 ug Panblok H7 Plus MF59
15 ug Panblok H7 Plus MF59
Serious adverse events
| Measure |
3.75 ug Panblok H7 Plus AS03
n=62 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 plus AS03
|
7.5 ug Panblok H7 Plus AS03
n=60 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with AS03
|
15 ug Panblok H7 Plus AS03
n=62 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with AS03
|
3.75 ug Panblok H7 Plus MF59
n=61 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 adjuvanted with MF59
|
7.5 ug Panblok H7 Plus MF59
n=60 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with MF59
|
15 ug Panblok H7 Plus MF59
n=61 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with MF59
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Colloid brain cyst
|
1.6%
1/62 • Number of events 1 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/62 • 13 months
|
0.00%
0/61 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Congenital, familial and genetic disorders
Cardiac septal defect
|
0.00%
0/62 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/62 • 13 months
|
1.6%
1/61 • Number of events 1 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Congenital, familial and genetic disorders
Pulmonary artery stenosis congenital
|
0.00%
0/62 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/62 • 13 months
|
1.6%
1/61 • Number of events 1 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Infections and infestations
Appendicitis
|
0.00%
0/62 • 13 months
|
0.00%
0/60 • 13 months
|
1.6%
1/62 • Number of events 1 • 13 months
|
0.00%
0/61 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/62 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/62 • 13 months
|
1.6%
1/61 • Number of events 1 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/62 • 13 months
|
0.00%
0/60 • 13 months
|
1.6%
1/62 • Number of events 1 • 13 months
|
0.00%
0/61 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/62 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/62 • 13 months
|
1.6%
1/61 • Number of events 1 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.6%
1/62 • Number of events 1 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/62 • 13 months
|
0.00%
0/61 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/62 • 13 months
|
0.00%
0/60 • 13 months
|
1.6%
1/62 • Number of events 1 • 13 months
|
0.00%
0/61 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.6%
1/62 • Number of events 1 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/62 • 13 months
|
0.00%
0/61 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/62 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/62 • 13 months
|
0.00%
0/61 • 13 months
|
1.7%
1/60 • Number of events 1 • 13 months
|
0.00%
0/61 • 13 months
|
|
Nervous system disorders
Monoplegia
|
1.6%
1/62 • Number of events 1 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/62 • 13 months
|
0.00%
0/61 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/62 • 13 months
|
1.7%
1/60 • Number of events 1 • 13 months
|
0.00%
0/62 • 13 months
|
0.00%
0/61 • 13 months
|
1.7%
1/60 • Number of events 1 • 13 months
|
0.00%
0/61 • 13 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/62 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/62 • 13 months
|
1.6%
1/61 • Number of events 1 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
Other adverse events
| Measure |
3.75 ug Panblok H7 Plus AS03
n=62 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 plus AS03
|
7.5 ug Panblok H7 Plus AS03
n=60 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with AS03
|
15 ug Panblok H7 Plus AS03
n=62 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with AS03
|
3.75 ug Panblok H7 Plus MF59
n=61 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 3.75 ug Panblok H7 adjuvanted with MF59
|
7.5 ug Panblok H7 Plus MF59
n=60 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 7.5 ug Panblok H7 adjuvanted with MF59
|
15 ug Panblok H7 Plus MF59
n=61 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 15 ug Panblok H7 adjuvanted with MF59
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
2/62 • Number of events 2 • 13 months
|
8.3%
5/60 • Number of events 7 • 13 months
|
14.5%
9/62 • Number of events 12 • 13 months
|
14.8%
9/61 • Number of events 10 • 13 months
|
16.7%
10/60 • Number of events 15 • 13 months
|
13.1%
8/61 • Number of events 9 • 13 months
|
|
Gastrointestinal disorders
Nausea
|
11.3%
7/62 • Number of events 9 • 13 months
|
11.7%
7/60 • Number of events 11 • 13 months
|
16.1%
10/62 • Number of events 10 • 13 months
|
19.7%
12/61 • Number of events 18 • 13 months
|
6.7%
4/60 • Number of events 5 • 13 months
|
14.8%
9/61 • Number of events 9 • 13 months
|
|
General disorders
Chills
|
11.3%
7/62 • Number of events 8 • 13 months
|
11.7%
7/60 • Number of events 10 • 13 months
|
9.7%
6/62 • Number of events 6 • 13 months
|
9.8%
6/61 • Number of events 7 • 13 months
|
8.3%
5/60 • Number of events 5 • 13 months
|
6.6%
4/61 • Number of events 4 • 13 months
|
|
General disorders
Fatigue
|
27.4%
17/62 • Number of events 22 • 13 months
|
25.0%
15/60 • Number of events 18 • 13 months
|
30.6%
19/62 • Number of events 24 • 13 months
|
26.2%
16/61 • Number of events 22 • 13 months
|
18.3%
11/60 • Number of events 13 • 13 months
|
16.4%
10/61 • Number of events 11 • 13 months
|
|
General disorders
Injection site erythema
|
8.1%
5/62 • Number of events 5 • 13 months
|
11.7%
7/60 • Number of events 8 • 13 months
|
4.8%
3/62 • Number of events 4 • 13 months
|
11.5%
7/61 • Number of events 8 • 13 months
|
3.3%
2/60 • Number of events 2 • 13 months
|
3.3%
2/61 • Number of events 2 • 13 months
|
|
General disorders
Injection site induration
|
4.8%
3/62 • Number of events 4 • 13 months
|
13.3%
8/60 • Number of events 11 • 13 months
|
9.7%
6/62 • Number of events 9 • 13 months
|
11.5%
7/61 • Number of events 9 • 13 months
|
3.3%
2/60 • Number of events 2 • 13 months
|
1.6%
1/61 • Number of events 1 • 13 months
|
|
General disorders
Injection site pain
|
67.7%
42/62 • Number of events 70 • 13 months
|
70.0%
42/60 • Number of events 68 • 13 months
|
58.1%
36/62 • Number of events 60 • 13 months
|
52.5%
32/61 • Number of events 44 • 13 months
|
48.3%
29/60 • Number of events 42 • 13 months
|
47.5%
29/61 • Number of events 45 • 13 months
|
|
General disorders
Pyrexia
|
1.6%
1/62 • Number of events 1 • 13 months
|
3.3%
2/60 • Number of events 2 • 13 months
|
6.5%
4/62 • Number of events 4 • 13 months
|
3.3%
2/61 • Number of events 2 • 13 months
|
0.00%
0/60 • 13 months
|
0.00%
0/61 • 13 months
|
|
Infections and infestations
Upper respiratory tract infection
|
11.3%
7/62 • Number of events 7 • 13 months
|
6.7%
4/60 • Number of events 4 • 13 months
|
3.2%
2/62 • Number of events 3 • 13 months
|
9.8%
6/61 • Number of events 7 • 13 months
|
10.0%
6/60 • Number of events 6 • 13 months
|
6.6%
4/61 • Number of events 5 • 13 months
|
|
Investigations
Blood creatine phosphokinase increased
|
3.2%
2/62 • Number of events 2 • 13 months
|
3.3%
2/60 • Number of events 2 • 13 months
|
4.8%
3/62 • Number of events 3 • 13 months
|
4.9%
3/61 • Number of events 3 • 13 months
|
6.7%
4/60 • Number of events 5 • 13 months
|
6.6%
4/61 • Number of events 4 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
5/62 • Number of events 6 • 13 months
|
10.0%
6/60 • Number of events 8 • 13 months
|
9.7%
6/62 • Number of events 6 • 13 months
|
13.1%
8/61 • Number of events 10 • 13 months
|
1.7%
1/60 • Number of events 1 • 13 months
|
3.3%
2/61 • Number of events 2 • 13 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.6%
14/62 • Number of events 20 • 13 months
|
31.7%
19/60 • Number of events 27 • 13 months
|
29.0%
18/62 • Number of events 24 • 13 months
|
26.2%
16/61 • Number of events 23 • 13 months
|
13.3%
8/60 • Number of events 10 • 13 months
|
21.3%
13/61 • Number of events 17 • 13 months
|
|
Nervous system disorders
Headache
|
33.9%
21/62 • Number of events 29 • 13 months
|
28.3%
17/60 • Number of events 26 • 13 months
|
25.8%
16/62 • Number of events 23 • 13 months
|
26.2%
16/61 • Number of events 20 • 13 months
|
26.7%
16/60 • Number of events 28 • 13 months
|
24.6%
15/61 • Number of events 21 • 13 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
2/62 • Number of events 3 • 13 months
|
1.7%
1/60 • Number of events 1 • 13 months
|
3.2%
2/62 • Number of events 2 • 13 months
|
6.6%
4/61 • Number of events 5 • 13 months
|
5.0%
3/60 • Number of events 3 • 13 months
|
3.3%
2/61 • Number of events 3 • 13 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place