Trial Outcomes & Findings for Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant (NCT NCT02680002)
NCT ID: NCT02680002
Last Updated: 2020-08-31
Results Overview
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
422 participants
Primary outcome timeframe
Days 0 to 7
Results posted on
2020-08-31
Participant Flow
Participants were screened and enrolled at 6 sites in the US.
Participant milestones
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
7.5 mcg H5N1 (stored as monobulk)
MF59
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
71
|
70
|
70
|
71
|
70
|
70
|
|
Overall Study
Day 0 (Dose 1)
|
70
|
70
|
70
|
71
|
70
|
68
|
|
Overall Study
Day 21 (Dose 2)
|
63
|
68
|
65
|
69
|
65
|
63
|
|
Overall Study
Day 201
|
58
|
66
|
60
|
67
|
59
|
61
|
|
Overall Study
COMPLETED
|
58
|
66
|
60
|
67
|
59
|
61
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
10
|
4
|
11
|
9
|
Reasons for withdrawal
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
7.5 mcg H5N1 (stored as monobulk)
MF59
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
4
|
2
|
0
|
2
|
|
Overall Study
Physician Decision
|
5
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
2
|
2
|
|
Overall Study
Missed Visit 8 (Day 201)
|
2
|
1
|
3
|
1
|
5
|
0
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
Baseline characteristics by cohort
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=70 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=68 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
Total
n=419 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
18 to <30
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
11 participants
n=5 Participants
|
17 participants
n=4 Participants
|
21 participants
n=21 Participants
|
15 participants
n=8 Participants
|
98 participants
n=8 Participants
|
|
Age, Customized
30 to <40
|
22 participants
n=5 Participants
|
21 participants
n=7 Participants
|
26 participants
n=5 Participants
|
28 participants
n=4 Participants
|
22 participants
n=21 Participants
|
31 participants
n=8 Participants
|
150 participants
n=8 Participants
|
|
Age, Customized
40 to 49
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
33 participants
n=5 Participants
|
26 participants
n=4 Participants
|
27 participants
n=21 Participants
|
22 participants
n=8 Participants
|
171 participants
n=8 Participants
|
|
Age, Customized
|
38.0 years
n=5 Participants
|
37.5 years
n=7 Participants
|
38.5 years
n=5 Participants
|
37.0 years
n=4 Participants
|
37.0 years
n=21 Participants
|
35.0 years
n=8 Participants
|
37 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
249 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
170 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
289 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
27 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
116 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
70 participants
n=7 Participants
|
70 participants
n=5 Participants
|
71 participants
n=4 Participants
|
70 participants
n=21 Participants
|
68 participants
n=8 Participants
|
419 participants
n=8 Participants
|
|
Body Mass Index (BMI)
|
30.93 kg/m2
n=5 Participants
|
28.95 kg/m2
n=7 Participants
|
29.79 kg/m2
n=5 Participants
|
28.08 kg/m2
n=4 Participants
|
30.21 kg/m2
n=21 Participants
|
30.84 kg/m2
n=8 Participants
|
29.70 kg/m2
n=8 Participants
|
PRIMARY outcome
Timeframe: Days 0 to 7Population: Participants who received Dose 1 (Day 0), analyzed up to Day 7.
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=70 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=68 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total number solicited local AEs (Adverse Events)
|
34 occurrences
|
41 occurrences
|
34 occurrences
|
34 occurrences
|
28 occurrences
|
33 occurrences
|
|
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Mild solicited AEs
|
31 occurrences
|
37 occurrences
|
30 occurrences
|
29 occurrences
|
23 occurrences
|
29 occurrences
|
|
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Moderate solicited AEs
|
3 occurrences
|
4 occurrences
|
4 occurrences
|
3 occurrences
|
5 occurrences
|
4 occurrences
|
|
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Severe solicited AEs
|
0 occurrences
|
0 occurrences
|
0 occurrences
|
2 occurrences
|
0 occurrences
|
0 occurrences
|
PRIMARY outcome
Timeframe: Days 21 to 28Population: Participants who received Dose 2 (Day 21), analyzed up to Day 28.
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 28) following Dose 2
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=63 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=68 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=65 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=69 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=65 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=63 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total number solicited local AEs (Adverse Events)
|
26 occurrences
|
24 occurrences
|
23 occurrences
|
24 occurrences
|
18 occurrences
|
23 occurrences
|
|
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Moderate solicited AEs
|
0 occurrences
|
2 occurrences
|
0 occurrences
|
1 occurrences
|
1 occurrences
|
2 occurrences
|
|
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Severe solicited AEs
|
0 occurrences
|
0 occurrences
|
0 occurrences
|
0 occurrences
|
0 occurrences
|
0 occurrences
|
|
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Mild solicited AEs
|
26 occurrences
|
22 occurrences
|
23 occurrences
|
23 occurrences
|
17 occurrences
|
21 occurrences
|
PRIMARY outcome
Timeframe: Days 0 to 7Population: Participants who received Dose 1 (Day 0), analyzed up to Day 7.
Number of participants with \>=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=70 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=68 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Mild solicited local AEs
|
23 Participants
|
28 Participants
|
24 Participants
|
24 Participants
|
18 Participants
|
21 Participants
|
|
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total number solicited local AEs (Adverse Events)
|
25 Participants
|
31 Participants
|
27 Participants
|
27 Participants
|
22 Participants
|
25 Participants
|
|
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Moderate solicited local AEs
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Severe solicited local AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 21 to 28Population: Participants who received Dose 2 (Day 21), analyzed up to Day 28.
Number of participants with \>=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 29) following Dose 2
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=63 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=68 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=65 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=69 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=65 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=63 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total number solicited local AEs (Adverse Events)
|
20 Participants
|
20 Participants
|
17 Participants
|
21 Participants
|
17 Participants
|
21 Participants
|
|
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Moderate solicited local AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Mild solicited local AEs
|
20 Participants
|
19 Participants
|
17 Participants
|
20 Participants
|
16 Participants
|
19 Participants
|
|
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Total no. Severe solicited local AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0 to 7Population: Participants who received Dose 1 (Day 0), analyzed up to Day 7.
Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=70 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=68 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Total no. Mild solicited systemic AEs
|
13 participants
Interval 10.3 to 29.7
|
14 participants
Interval 11.4 to 31.3
|
17 participants
Interval 14.8 to 36.0
|
19 participants
Interval 16.9 to 38.6
|
13 participants
Interval 10.3 to 29.7
|
13 participants
Interval 10.6 to 30.5
|
|
Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Total no. Moderate solicited systemic AEs
|
7 participants
Interval 4.1 to 19.5
|
3 participants
Interval 0.9 to 12.0
|
6 participants
Interval 3.2 to 17.7
|
4 participants
Interval 1.6 to 13.8
|
4 participants
Interval 1.6 to 14.0
|
3 participants
Interval 0.9 to 12.4
|
|
Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Total no. Severe solicited systemic AEs
|
0 participants
Interval 0.0 to 5.1
|
0 participants
Interval 0.0 to 5.1
|
0 participants
Interval 0.0 to 5.1
|
1 participants
Interval 0.0 to 7.6
|
0 participants
Interval 0.0 to 5.1
|
2 participants
Interval 0.4 to 10.2
|
|
Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Total no. solicited systemic AEs (Adverse Events)
|
20 participants
Interval 18.4 to 40.6
|
17 participants
Interval 14.8 to 36.0
|
23 participants
Interval 22.1 to 45.1
|
24 participants
Interval 23.0 to 46.0
|
17 participants
Interval 14.8 to 36.0
|
18 participants
Interval 16.5 to 38.6
|
PRIMARY outcome
Timeframe: Days 21 to 28Population: Participants who received Dose 2 (Day 21), analyzed up to Day 28.
Number of participants with of mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 21 to 28) following Dose 2
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=63 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=38 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=65 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=59 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=65 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=63 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Total no. Mild solicited systemic AEs
|
8 participants
Interval 5.6 to 23.5
|
10 participants
Interval 7.3 to 25.4
|
10 participants
Interval 7.6 to 26.5
|
11 participants
Interval 8.2 to 26.7
|
5 participants
Interval 2.5 to 17.0
|
9 participants
Interval 6.7 to 25.4
|
|
Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Total no. Severe solicited systemic AEs
|
0 participants
Interval 0.0 to 5.7
|
0 participants
Interval 0.0 to 5.7
|
0 participants
Interval 0.0 to 5.5
|
0 participants
Interval 0.0 to 5.2
|
0 participants
Interval 0.0 to 5.5
|
0 participants
Interval 0.0 to 5.7
|
|
Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Total no. solicited systemic AEs (Adverse Events)
|
11 participants
Interval 9.1 to 29.1
|
10 participants
Interval 7.3 to 25.4
|
11 participants
Interval 8.8 to 28.3
|
17 participants
Interval 15.1 to 36.5
|
9 participants
Interval 6.5 to 24.7
|
9 participants
Interval 6.7 to 25.4
|
|
Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Total no. Moderate solicited systemic AEs
|
3 participants
Interval 1.0 to 13.3
|
0 participants
Interval 0.0 to 5.3
|
1 participants
Interval 0.0 to 8.3
|
6 participants
Interval 3.3 to 18.0
|
4 participants
Interval 1.7 to 15.0
|
0 participants
Interval 0.0 to 5.7
|
PRIMARY outcome
Timeframe: 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)Population: Participants who received Dose 2 (Day 28) of vaccine, analyzed at Day 42 (plus or minus 3 days).
Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=61 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=67 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=62 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=69 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=65 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=61 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody
|
38 antibody titers
Interval 28.7 to 50.4
|
29.6 antibody titers
Interval 22.6 to 38.9
|
37.4 antibody titers
Interval 28.3 to 49.4
|
49.4 antibody titers
Interval 37.7 to 64.8
|
19.4 antibody titers
Interval 14.6 to 25.7
|
19.9 antibody titers
Interval 13.9 to 28.4
|
PRIMARY outcome
Timeframe: 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)Population: Participants who received Dose 2 (Day 28) of vaccine, analyzed at Day 42 (plus or minus 3 days).
Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=61 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=67 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=62 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=69 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=65 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=61 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody
|
40.0 antibody titers
Interval 5.0 to 320.0
|
40.0 antibody titers
Interval 5.0 to 226.0
|
40.0 antibody titers
Interval 5.0 to 453.0
|
56.6 antibody titers
Interval 5.0 to 640.0
|
20 antibody titers
Interval 5.0 to 640.0
|
14.1 antibody titers
Interval 5.0 to 905.0
|
SECONDARY outcome
Timeframe: First vaccination through 13 monthsNumber of participants with vaccine-associated serious adverse events (SAE) or adverse event of special interests (AESI) and occurence of AESIs or AEs leading to study withdrawal
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=70 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=69 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI)
Adverse Event of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI)
Vaccine-associated Serious Adverse Event (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: First vaccination through approximately 13 months after first vaccinationNumber of participants with adverse events of special interest (AESI) or adverse events (AE) leading to study withdrawal.
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=70 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=69 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal.
Adverse Events (AE) leading to study withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal.
Adverse Event of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 (Visit 1) through Day 201 (Visit 8)Number of participants with unsolicited adverse events (AE) through Visit 8 (Day 201)
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=70 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=69 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events (AE)
Any unsolicited Adverse Event (AE)
|
28 Participants
|
37 Participants
|
36 Participants
|
42 Participants
|
31 Participants
|
27 Participants
|
|
Number of Participants With Unsolicited Adverse Events (AE)
Any severe unsolicited Adverse Event (AE)
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 21 days following each vaccination (Days 0-21, >21 Days)Frequency of unsolicited adverse events (AE) for 21 days following Dose 1 (Days 0-21) and after Dose 2 (\>21 Days)
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=70 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=69 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Frequency of Unsolicited Adverse Events (AE)
Days 0-21
|
184 Unsolicited Adverse Events (AE)
|
179 Unsolicited Adverse Events (AE)
|
186 Unsolicited Adverse Events (AE)
|
202 Unsolicited Adverse Events (AE)
|
156 Unsolicited Adverse Events (AE)
|
174 Unsolicited Adverse Events (AE)
|
|
Frequency of Unsolicited Adverse Events (AE)
>21 Days
|
0 Unsolicited Adverse Events (AE)
|
1 Unsolicited Adverse Events (AE)
|
4 Unsolicited Adverse Events (AE)
|
2 Unsolicited Adverse Events (AE)
|
1 Unsolicited Adverse Events (AE)
|
4 Unsolicited Adverse Events (AE)
|
SECONDARY outcome
Timeframe: 7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42)Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=70 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=71 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=70 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=69 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Occurrence of Clinical Safety Laboratory AEs
Visit 3: Day 7
|
0 Clinical safety lab results reported
|
1 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
1 Clinical safety lab results reported
|
|
Occurrence of Clinical Safety Laboratory AEs
Visit 4: Day 21
|
0 Clinical safety lab results reported
|
1 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
|
Occurrence of Clinical Safety Laboratory AEs
Visit 6: Day 28
|
0 Clinical safety lab results reported
|
1 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
|
Occurrence of Clinical Safety Laboratory AEs
Visit 7: Day 42
|
0 Clinical safety lab results reported
|
1 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
|
Occurrence of Clinical Safety Laboratory AEs
Visit 1: Day 0
|
0 Clinical safety lab results reported
|
1 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
0 Clinical safety lab results reported
|
SECONDARY outcome
Timeframe: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8)Population: Population receiving Dose 1 at Day 0 (Visit 1)
Overall GMTs of HAI antibodies at baseline (Day 0) and Days 21, 28 and 201
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=61 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=67 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=62 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=69 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=65 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=61 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies
Visit 4: Day 21 (+1 day)
|
11.8 antibody titers
Interval 9.0 to 15.4
|
8.6 antibody titers
Interval 7.0 to 10.4
|
8.7 antibody titers
Interval 6.7 to 11.4
|
14.8 antibody titers
Interval 11.1 to 19.7
|
10.8 antibody titers
Interval 8.0 to 14.6
|
14.1 antibody titers
Interval 9.6 to 20.9
|
|
GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies
Visit 6: Day 28 (+1 day)
|
18.4 antibody titers
Interval 13.8 to 24.5
|
18.7 antibody titers
Interval 14.0 to 25.0
|
17.5 antibody titers
Interval 13.2 to 23.2
|
27.9 antibody titers
Interval 20.5 to 37.9
|
14.0 antibody titers
Interval 10.3 to 19.1
|
20.7 antibody titers
Interval 14.3 to 30.0
|
|
GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies
Visit 8: Day 201 (plus or minus 7 days)
|
6.2 antibody titers
Interval 5.3 to 7.2
|
5.4 antibody titers
Interval 5.1 to 5.7
|
5.5 antibody titers
Interval 5.0 to 5.9
|
5.4 antibody titers
Interval 5.1 to 5.8
|
5.9 antibody titers
Interval 5.1 to 6.8
|
6.9 antibody titers
Interval 5.6 to 8.6
|
|
GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies
Visit 1: Day 0
|
5.0 antibody titers
Interval 5.0 to 5.1
|
5.0 antibody titers
Interval 5.0 to 5.1
|
5.4 antibody titers
Interval 5.0 to 5.8
|
5.2 antibody titers
Interval 4.9 to 5.6
|
5.1 antibody titers
Interval 5.0 to 5.2
|
5.3 antibody titers
Interval 4.9 to 5.8
|
SECONDARY outcome
Timeframe: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8)Population: Population receiving Dose 1 at Day 0 (Visit 1)
GMT of serum MN antibodies at baseline (Day 0) and Days 21, 28, 42 and 201
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=61 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=67 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=62 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=69 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=65 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=61 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
Visit 1: Day 0
|
6.1 antibody titers
Interval 5.6 to 6.6
|
5.5 antibody titers
Interval 5.2 to 5.8
|
5.5 antibody titers
Interval 5.2 to 5.7
|
6.0 antibody titers
Interval 5.6 to 6.5
|
5.4 antibody titers
Interval 5.1 to 5.7
|
5.7 antibody titers
Interval 5.4 to 6.1
|
|
GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
Visit 4: Day 21 (+1 day)
|
12.2 antibody titers
Interval 9.3 to 16.1
|
8.0 antibody titers
Interval 6.9 to 9.3
|
10.9 antibody titers
Interval 8.4 to 14.1
|
14.2 antibody titers
Interval 11.0 to 18.4
|
10.7 antibody titers
Interval 8.2 to 13.8
|
15.4 antibody titers
Interval 10.5 to 22.6
|
|
GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
Visit 6: Day 28 (+1 day)
|
24.0 antibody titers
Interval 18.6 to 31.0
|
23.8 antibody titers
Interval 19.1 to 29.7
|
24.9 antibody titers
Interval 19.6 to 31.6
|
31.1 antibody titers
Interval 24.1 to 40.2
|
16.8 antibody titers
Interval 13.2 to 21.3
|
24.0 antibody titers
Interval 16.9 to 34.1
|
|
GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
Visit 7: Day 42 (plus or minus 3 days)
|
52.2 antibody titers
Interval 39.2 to 69.7
|
43.0 antibody titers
Interval 33.8 to 54.7
|
58.8 antibody titers
Interval 45.4 to 76.1
|
66.4 antibody titers
Interval 52.3 to 84.3
|
25.0 antibody titers
Interval 20.2 to 31.0
|
30.1 antibody titers
Interval 22.0 to 41.3
|
|
GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
Visit 8: Day 201 (plus or minus 7 days)
|
11.3 antibody titers
Interval 9.1 to 14.0
|
8.8 antibody titers
Interval 7.5 to 10.1
|
10.9 antibody titers
Interval 8.7 to 13.5
|
9.9 antibody titers
Interval 8.3 to 11.7
|
8.9 antibody titers
Interval 7.3 to 10.8
|
11.0 antibody titers
Interval 8.0 to 15.0
|
SECONDARY outcome
Timeframe: Days 0 (Visit 1), 21 (Visit 4, +1day), 28 (Visit 6, +1 day), 42 (Visit 7, plus or minus 3 days), and 201 (Visit 8, plus or minus 7 days)Population: Participants who satisfied the predefined criteria for assessment.
Proportion of participants achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=61 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=67 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=62 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=69 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=65 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=61 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
Day 0 (Visit 1)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
Day 21 (Visit 4, +1 day)
|
13 Participants
|
6 Participants
|
9 Participants
|
18 Participants
|
12 Participants
|
16 Participants
|
|
Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
Day 28 (Visit 6, +1 day)
|
22 Participants
|
25 Participants
|
18 Participants
|
33 Participants
|
19 Participants
|
22 Participants
|
|
Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
Day 42 (Visit 7, plus or minus 3 days)
|
39 Participants
|
38 Participants
|
42 Participants
|
49 Participants
|
21 Participants
|
22 Participants
|
|
Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
Day 201 (Visit 8, plus or minus 7 days)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 21, 28, 42, and 201Population: Participants who satisfied the predefined criteria
Defined as proportion of subjects achieving either a prevaccination HAI titer of \<1:10 and postvaccination titer of at least 1:40 or a prevaccination HAI titer of at least 1:10 and a 4-fold or greater increase of HAI postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline HAI titer is undetectable, it will be assigned a vaue of half the lower limit of detection.
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=61 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=67 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=62 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=69 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=65 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=61 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies
Visit 4: Day 21 (+1 day)
|
13 Participants
|
6 Participants
|
8 Participants
|
18 Participants
|
12 Participants
|
16 Participants
|
|
Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies
Visit 6: Day 28 (+1day)
|
22 Participants
|
25 Participants
|
17 Participants
|
33 Participants
|
19 Participants
|
21 Participants
|
|
Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies
Visit 7: Day 42 (plus or minus 3 days)
|
39 Participants
|
38 Participants
|
41 Participants
|
49 Participants
|
21 Participants
|
21 Participants
|
|
Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies
Visit 8: Day 201 (plus or minus 7 days)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Days 21, 28, 42, and 201Population: Participants who satisfied the predefined criteria
Defined as proportion of subjects achieving either a prevaccination MN titer of \<1:10 and postvaccination titer of at least 1:40 or a prevaccination MN titer of at least 1:10 and a 4-fold or greater increase of MN postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline MN titer is undetectable, it will be assigned a vaue of half the lower limit of detection.
Outcome measures
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=61 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=67 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=62 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=69 Participants
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=65 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=61 Participants
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies
Visit 6: Day 28 (+1day)
|
18 Participants
|
21 Participants
|
23 Participants
|
31 Participants
|
15 Participants
|
20 Participants
|
|
Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies
Visit 7: Day 42 (plus or minus 3 days)
|
42 Participants
|
43 Participants
|
44 Participants
|
52 Participants
|
23 Participants
|
23 Participants
|
|
Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies
Visit 4: Day 21 (+1 day)
|
10 Participants
|
3 Participants
|
11 Participants
|
13 Participants
|
9 Participants
|
12 Participants
|
|
Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies
Visit 8: Day 201 (plus or minus 7 days)
|
5 Participants
|
1 Participants
|
8 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
Adverse Events
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
Serious events: 3 serious events
Other events: 47 other events
Deaths: 0 deaths
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
90 mcg H5N1 (Monobulk) Without MF59
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
90 mcg H5N1 (Vials) Without MF59
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 participants at risk
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=71 participants at risk
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=70 participants at risk
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=71 participants at risk
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=70 participants at risk
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=69 participants at risk
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/71 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/69 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Musculoskeletal and connective tissue disorders
Joint dislocation
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/70 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/69 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Skin and subcutaneous tissue disorders
Infected skin ulcer
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/70 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/69 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/70 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/69 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/70 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/69 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
General disorders
Dehydration
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/70 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/69 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/70 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/69 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Surgical and medical procedures
Pseudomeningocele
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/70 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/69 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Injury, poisoning and procedural complications
Abdominal pain
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/69 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Injury, poisoning and procedural complications
Gastrointestinal organ contusion
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/69 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/69 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Injury, poisoning and procedural complications
Flank pain
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/69 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Vascular disorders
Acute myocardial infarction
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/69 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
General disorders
Organ failure
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/69 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/71 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
0.00%
0/70 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
1.4%
1/69 • Number of events 1 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
Other adverse events
| Measure |
7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=70 participants at risk
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk)
n=71 participants at risk
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant
|
7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=70 participants at risk
Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
15 mcg H5N1 (Monobulk) Plus MF59 (Vials)
n=71 participants at risk
Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant
|
90 mcg H5N1 (Monobulk) Without MF59
n=70 participants at risk
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59
|
90 mcg H5N1 (Vials) Without MF59
n=69 participants at risk
Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site pain
|
42.9%
30/70 • Number of events 30 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
46.5%
33/71 • Number of events 33 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
41.4%
29/70 • Number of events 29 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
46.5%
33/71 • Number of events 33 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
35.7%
25/70 • Number of events 25 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
42.0%
29/69 • Number of events 29 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
General disorders
Fatigue
|
20.0%
14/70 • Number of events 14 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
19.7%
14/71 • Number of events 14 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
17.1%
12/70 • Number of events 12 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
19.7%
14/71 • Number of events 14 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
15.7%
11/70 • Number of events 11 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
17.4%
12/69 • Number of events 12 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
General disorders
Injection site induration
|
11.4%
8/70 • Number of events 8 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
12.7%
9/71 • Number of events 9 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
10.0%
7/70 • Number of events 7 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
5.6%
4/71 • Number of events 4 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
5.7%
4/70 • Number of events 4 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
11.6%
8/69 • Number of events 8 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
General disorders
Injection site erythema
|
8.6%
6/70 • Number of events 6 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
7.0%
5/71 • Number of events 5 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
7.1%
5/70 • Number of events 5 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
4.2%
3/71 • Number of events 3 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
8.6%
6/70 • Number of events 6 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
10.1%
7/69 • Number of events 7 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Nervous system disorders
Headache
|
24.3%
17/70 • Number of events 17 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
21.1%
15/71 • Number of events 15 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
21.4%
15/70 • Number of events 15 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
31.0%
22/71 • Number of events 22 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
18.6%
13/70 • Number of events 13 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
24.6%
17/69 • Number of events 17 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
7/70 • Number of events 7 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
16.9%
12/71 • Number of events 12 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
15.7%
11/70 • Number of events 11 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
18.3%
13/71 • Number of events 13 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
10.0%
7/70 • Number of events 7 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
10.1%
7/69 • Number of events 7 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
4/70 • Number of events 4 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
5.6%
4/71 • Number of events 4 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
10.0%
7/70 • Number of events 7 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
7.0%
5/71 • Number of events 5 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
10.0%
7/70 • Number of events 7 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
4.3%
3/69 • Number of events 3 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
7/70 • Number of events 7 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
7.0%
5/71 • Number of events 5 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
12.9%
9/70 • Number of events 9 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
9.9%
7/71 • Number of events 7 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
8.6%
6/70 • Number of events 6 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
15.9%
11/69 • Number of events 11 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
|
Gastrointestinal disorders
Nausea
|
8.6%
6/70 • Number of events 6 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
5.6%
4/71 • Number of events 4 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
7.1%
5/70 • Number of events 5 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
12.7%
9/71 • Number of events 9 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
2.9%
2/70 • Number of events 2 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
4.3%
3/69 • Number of events 3 • Adverse Event (AE) data were collected from Visit 1 (Day 0) through Visit 7 (Day 42); Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) were assessed from Visit 1 (Day 0), until exit from the study, Visit 9 (Day 386). Data currently available to Visit 8 (Day 201).
Subjects recorded solicited local and systemic reactions to the vaccine or adjuvant, and other unsolicited symptoms or complaints, including start and stop dates, on an 8-day diary card following each of the 2 vaccinations. Diary cards captured unsolicited AEs for 21 days after each vaccination. Regular investigator assessment at each visit, except Visit 1. Abnormal laboratory test results judged clinically significant by investigator recorded as AEs or SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Data and results owned by Sponsor. Results can be used by Institution for (a) internal non-commercial research, education and patient care, and (b) as required under applicable laws and regulations. Other uses require prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER