Trial Outcomes & Findings for VELOCITY: An Anthrax Vaccine Clinical Study (NCT NCT03877926)
NCT ID: NCT03877926
Last Updated: 2026-05-06
Results Overview
GMT of TNA NF50 at Day 64 in AV7909 study groups (Lots 1, 2 and 3) and BioThrax group. The outcome measure in AV7909 study groups was assessed for AV7909 lot-to-lot consistency, which was based on GMT TNA NF50 response at Day 64, wherein the 95% confidence interval (CI) for ratios of geometric mean titer (GMT) of TNA NF50 at Day 64 (seven weeks after second AV7909 vaccination) for each of the three AV7909 lot-to-lot comparisons had to be within equivalence margin of 0.5 and 2.0.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3689 participants
Primary outcome timeframe
Day 64 (seven weeks after second AV7909 vaccination)
Results posted on
2026-05-06
Participant Flow
Participant milestones
| Measure |
AV7909 Lot 1
Eligible participants randomized to receive AV7909 Lot 1.
AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax® vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.
|
AV7909 Lot 2
Eligible participants randomized to receive AV7909 Lot 2.
AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.
|
AV7909 Lot 3
Eligible participants randomized to receive AV7909 Lot 3.
AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.
|
BioThrax
Eligible participants randomized to receive BioThrax vaccine.
BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1053
|
1054
|
1049
|
533
|
|
Overall Study
Received at Least One Study Vaccination
|
1050
|
1053
|
1048
|
533
|
|
Overall Study
Did Not Receive Any Study Vaccination
|
3
|
1
|
1
|
0
|
|
Overall Study
COMPLETED
|
984
|
977
|
987
|
512
|
|
Overall Study
NOT COMPLETED
|
69
|
77
|
62
|
21
|
Reasons for withdrawal
| Measure |
AV7909 Lot 1
Eligible participants randomized to receive AV7909 Lot 1.
AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax® vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.
|
AV7909 Lot 2
Eligible participants randomized to receive AV7909 Lot 2.
AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.
|
AV7909 Lot 3
Eligible participants randomized to receive AV7909 Lot 3.
AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.
|
BioThrax
Eligible participants randomized to receive BioThrax vaccine.
BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
41
|
52
|
45
|
17
|
|
Overall Study
Physician Decision
|
2
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
16
|
21
|
11
|
4
|
|
Overall Study
Other - Various
|
4
|
1
|
1
|
0
|
|
Overall Study
Not Treated
|
3
|
1
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
2
|
2
|
2
|
0
|
Baseline Characteristics
VELOCITY: An Anthrax Vaccine Clinical Study
Baseline characteristics by cohort
| Measure |
Total
n=3684 Participants
Total of all reporting groups
|
AV7909 Lot 1
n=1050 Participants
Eligible participants randomized to receive AV7909 Lot 1.
|
AV7909 Lot 2
n=1053 Participants
Eligible participants randomized to receive AV7909 Lot 2.
|
AV7909 Lot 3
n=1048 Participants
Eligible participants randomized to receive AV7909 Lot 3.
|
BioThrax
n=533 Participants
Eligible participants randomized to receive BioThrax vaccine.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 12.9 • n=24 Participants
|
39.2 years
STANDARD_DEVIATION 13.1 • n=54 Participants
|
39.4 years
STANDARD_DEVIATION 13.0 • n=60 Participants
|
39.1 years
STANDARD_DEVIATION 12.9 • n=114 Participants
|
38.7 years
STANDARD_DEVIATION 12.4 • n=480 Participants
|
|
Age, Customized
18-30 years
|
1161 Participants
n=24 Participants
|
323 Participants
n=54 Participants
|
335 Participants
n=60 Participants
|
334 Participants
n=114 Participants
|
169 Participants
n=480 Participants
|
|
Age, Customized
31-50 years
|
1634 Participants
n=24 Participants
|
472 Participants
n=54 Participants
|
448 Participants
n=60 Participants
|
460 Participants
n=114 Participants
|
254 Participants
n=480 Participants
|
|
Age, Customized
51-65 years
|
889 Participants
n=24 Participants
|
255 Participants
n=54 Participants
|
270 Participants
n=60 Participants
|
254 Participants
n=114 Participants
|
110 Participants
n=480 Participants
|
|
Sex: Female, Male
Female
|
2119 Participants
n=24 Participants
|
620 Participants
n=54 Participants
|
588 Participants
n=60 Participants
|
618 Participants
n=114 Participants
|
293 Participants
n=480 Participants
|
|
Sex: Female, Male
Male
|
1565 Participants
n=24 Participants
|
430 Participants
n=54 Participants
|
465 Participants
n=60 Participants
|
430 Participants
n=114 Participants
|
240 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race : American Indian or Alaska Native
|
15 Participants
n=24 Participants
|
4 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
2 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race : Asian
|
71 Participants
n=24 Participants
|
17 Participants
n=54 Participants
|
17 Participants
n=60 Participants
|
23 Participants
n=114 Participants
|
14 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race : Black or African American
|
629 Participants
n=24 Participants
|
168 Participants
n=54 Participants
|
186 Participants
n=60 Participants
|
187 Participants
n=114 Participants
|
88 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race : Native Hawaiian or Other Pacific Islander
|
10 Participants
n=24 Participants
|
2 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
1 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race : White
|
2868 Participants
n=24 Participants
|
827 Participants
n=54 Participants
|
818 Participants
n=60 Participants
|
807 Participants
n=114 Participants
|
416 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race : More than One Race
|
65 Participants
n=24 Participants
|
22 Participants
n=54 Participants
|
20 Participants
n=60 Participants
|
14 Participants
n=114 Participants
|
9 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race : Other
|
17 Participants
n=24 Participants
|
8 Participants
n=54 Participants
|
3 Participants
n=60 Participants
|
5 Participants
n=114 Participants
|
1 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Race : Unknown
|
9 Participants
n=24 Participants
|
2 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
2 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Not Hispanic or Latino
|
3071 Participants
n=24 Participants
|
859 Participants
n=54 Participants
|
890 Participants
n=60 Participants
|
897 Participants
n=114 Participants
|
425 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Hispanic or Latino
|
567 Participants
n=24 Participants
|
175 Participants
n=54 Participants
|
154 Participants
n=60 Participants
|
140 Participants
n=114 Participants
|
98 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Unknown
|
18 Participants
n=24 Participants
|
4 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
4 Participants
n=480 Participants
|
|
Race/Ethnicity, Customized
Ethnicity: Not Reported
|
28 Participants
n=24 Participants
|
12 Participants
n=54 Participants
|
7 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
6 Participants
n=480 Participants
|
|
Region of Enrollment
United States
|
3684 Participants
n=24 Participants
|
1050 Participants
n=54 Participants
|
1053 Participants
n=60 Participants
|
1048 Participants
n=114 Participants
|
533 Participants
n=480 Participants
|
|
Body Mass Index
|
27.2 kg/m^2
STANDARD_DEVIATION 4.3 • n=24 Participants
|
27.0 kg/m^2
STANDARD_DEVIATION 4.3 • n=54 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 4.3 • n=60 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 4.4 • n=114 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 4.2 • n=480 Participants
|
PRIMARY outcome
Timeframe: Day 64 (seven weeks after second AV7909 vaccination)Population: Participants that met protocol-defined immunogenicity criteria from AV7909 Lot 1 group (n=835), AV7909 Lot 2 group (n=854), AV7909 Lot 3 group (n=854) and BioThrax group (n=430) are included.
GMT of TNA NF50 at Day 64 in AV7909 study groups (Lots 1, 2 and 3) and BioThrax group. The outcome measure in AV7909 study groups was assessed for AV7909 lot-to-lot consistency, which was based on GMT TNA NF50 response at Day 64, wherein the 95% confidence interval (CI) for ratios of geometric mean titer (GMT) of TNA NF50 at Day 64 (seven weeks after second AV7909 vaccination) for each of the three AV7909 lot-to-lot comparisons had to be within equivalence margin of 0.5 and 2.0.
Outcome measures
| Measure |
AV7909 Lot 1
n=835 Participants
Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 2
n=854 Participants
Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 3
n=854 Participants
Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.15 at Day 29.
|
BioThrax
n=430 Participants
Eligible participants randomized to receive BioThrax vaccine.
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) 50% Neutralization Factor (NF50) at Day 64
|
0.765 Titer (TNA NF50)
Interval 0.718 to 0.814
|
0.741 Titer (TNA NF50)
Interval 0.698 to 0.788
|
0.716 Titer (TNA NF50)
Interval 0.673 to 0.762
|
0.330 Titer (TNA NF50)
Interval 0.299 to 0.363
|
PRIMARY outcome
Timeframe: Day 64 (seven weeks after second AV7909 vaccination)Population: Data from participants that met protocol-defined criteria for inclusion in the immunogenicity population are included in the analysis; i.e., AV7909 Lot 1 n=835; AV7909 Lot 2 n=854; AV7909 Lot 3 n=854. Pre-defined success criteria (lower bound of the two-sided 95% CI to be ≥40% for the percentage of participants achieving a TNA NF50 ≥0.56 at Day 64) was only applicable for AV7909 study groups and not for BioThrax group; therefore, BioThrax group is not included.
Proportion of participants with TNA NF50 ≥0.56 at Day 64 in each AV7909 study groups (Lot 1, Lot 2, Lot 3). The assessment of the immune response in each study group was pre-defined as the lower bound of the two-sided 95% CI to be ≥40% for the percentage of AV7909 participants in each of the three lots achieving a TNA NF50 ≥0.56 at seven weeks after second AV7909 vaccination (Day 64).
Outcome measures
| Measure |
AV7909 Lot 1
n=835 Participants
Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 2
n=854 Participants
Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 3
n=854 Participants
Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.15 at Day 29.
|
BioThrax
Eligible participants randomized to receive BioThrax vaccine.
|
|---|---|---|---|---|
|
Percentage of Participants in AV7909 Lot 1, Lot 2 and Lot 3 Groups Achieving a TNA NF50 ≥0.56 on Day 64
|
68.9 percentage of participants
Interval 65.6 to 72.0
|
65.6 percentage of participants
Interval 62.3 to 68.8
|
64.4 percentage of participants
Interval 61.1 to 67.6
|
—
|
PRIMARY outcome
Timeframe: Day 64 (seven weeks after second AV7909 vaccination)Population: Data from participants who met protocol-defined criteria for inclusion in the immunogenicity population from all three AV7909 study groups (i.e., pooled AV7909; n=2543) were used for the analysis. The pre-defined success criteria (lower bound of the two-sided 95% CI to be ≥40% for the percentage of participants achieving a TNA NF50 ≥0.56 on Day 64) was not applicable for BioThrax participants, therefore BioThrax group was not included.
Percentage of AV7909 participants (from all three AV7909 study groups pooled) achieving a TNA NF50 ≥0.56 on Day 64 (seven weeks after second AV7909 vaccination). The assessment of the immune response in AV7909 participants was pre-defined as the lower bound of the two-sided 95% CI for proportion of AV7909 participants with TNA NF50 ≥0.56 at Day 64 ≥40%.
Outcome measures
| Measure |
AV7909 Lot 1
n=2543 Participants
Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 2
Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 3
Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.15 at Day 29.
|
BioThrax
Eligible participants randomized to receive BioThrax vaccine.
|
|---|---|---|---|---|
|
Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.56 on Day 64
|
66.3 percentage of participants
Interval 64.4 to 68.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 64 (seven weeks after second AV7909 vaccination; five weeks after third BioThrax vaccination)Population: Data from participants who met protocol-defined criteria for inclusion in the immunogenicity population from each AV7909 study group (Lot 1 n=835; Lot 2 n=854; Lot 3 n=854) and BioThrax group (n=430) were used in the analysis. For the non-inferiority assessment, participants who met pre-defined criteria (achievement of TNA NF50 ≥0.29 at Day 64) from the pooled AV7909 study groups 1-3 (AV7909 Lot 1, Lot 2, Lot 3; i.e., Pooled AV7909) and BioThrax group were included.
Proportion of AV7909 participants (in each AV7909 study groups) and BioThrax participants who achieved TNA NF50 ≥0.29 at Day 64. Non-inferiority of AV7909 vaccine to BioThrax vaccine at Day 64 was assessed as determined by the two-sided lower bound for the 95% CI of the difference in the percentage of AV7909 participants (three lots pooled) with a TNA NF50 ≥0.29 and the percentage of BioThrax participants with a TNA NF50 ≥0.29 being greater than -15%.
Outcome measures
| Measure |
AV7909 Lot 1
n=835 Participants
Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 2
n=854 Participants
Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 3
n=854 Participants
Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.15 at Day 29.
|
BioThrax
n=430 Participants
Eligible participants randomized to receive BioThrax vaccine.
|
|---|---|---|---|---|
|
Percentage of AV7909 Participants and BioThrax Participants With TNA NF50 ≥0.29 at Day 64
|
87.4 percentage of participants
Interval 85.0 to 89.6
|
86.8 percentage of participants
Interval 84.3 to 89.0
|
85.7 percentage of participants
Interval 83.2 to 88.0
|
61.4 percentage of participants
Interval 56.6 to 66.0
|
PRIMARY outcome
Timeframe: Day 1 though Day 394Population: For the relative risk of SAE incidence analysis, participants from all three AV7909 study groups (Lot 1, Lot 2, Lot 3) since AV7909 lots 1, 2 and 3 were considered the same product (consecutively manufactured, and released with the same product specifications); hence, it was pre-defined to combine SAE data from participants across the three AV7909 lots for SAE relative risk analysis.
Number of AV7909 participants or BioThrax participants who received at least one vaccination and reported serious adverse event(s) (SAEs) from the time of the first vaccination on Day 1 through Day 394.
Outcome measures
| Measure |
AV7909 Lot 1
n=1050 Participants
Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 2
n=1053 Participants
Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 3
n=1048 Participants
Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.15 at Day 29.
|
BioThrax
n=533 Participants
Eligible participants randomized to receive BioThrax vaccine.
|
|---|---|---|---|---|
|
Incidence of Serious Adverse Events
|
21 Participants
|
16 Participants
|
21 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 29 (two weeks after second AV7909 vaccination)Population: Data from participants who met protocol-defined criteria for inclusion in the immunogenicity population (AV7909 study groups 1-3) were used in the analysis. The pre-defined success criteria (lower bound of the two-sided 95% CI to be ≥67% for the percentage of participants achieving a TNA NF50 ≥0.15 on Day 29) was not applicable for BioThrax, therefore BioThrax group was not included.
Proportion of AV7909 participants (in each AV7909 study group) who achieved TNA NF50 ≥0.15 at Day 29 (two weeks after second AV7909 vaccination). Assessment of the lower bound of the two-sided 95% CI to be ≥67% for the percentage of AV7909 participants in AV7909 study groups 1-3 (Pooled AV7909) achieving a TNA NF50 ≥0.15 on Day 29 was performed.
Outcome measures
| Measure |
AV7909 Lot 1
n=835 Participants
Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 2
n=854 Participants
Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 3
n=854 Participants
Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.15 at Day 29.
|
BioThrax
Eligible participants randomized to receive BioThrax vaccine.
|
|---|---|---|---|---|
|
Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.15 on Day 29.
|
98.3 percentage of participants
Interval 97.2 to 99.1
|
97.8 percentage of participants
Interval 96.6 to 98.7
|
97.4 percentage of participants
Interval 96.0 to 98.3
|
—
|
SECONDARY outcome
Timeframe: Day 1 through Day 64Population: Data from participants who received at least one dose of AV7909 vaccine Lot 1 (n=1050), Lot 2 (n=1053) or Lot 3 (n=1048) or BioThrax vaccine (n=533) are included in the analysis.
Number of AV7909 or BioThrax participants who received at least one vaccination and had at least one treatment-emergent adverse event reported from the time of the first vaccination on Day 1 through Day 64.
Outcome measures
| Measure |
AV7909 Lot 1
n=1050 Participants
Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 2
n=1053 Participants
Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 3
n=1048 Participants
Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.15 at Day 29.
|
BioThrax
n=533 Participants
Eligible participants randomized to receive BioThrax vaccine.
|
|---|---|---|---|---|
|
Incidence of Adverse Events
|
310 Participants
|
315 Participants
|
336 Participants
|
221 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 394Population: Data from participants who received at least one dose of AV7909 vaccine (Lot 1, Lot 2 or Lot 3) or BioThrax vaccine are used in the analysis. Since AV7909 lots 1, 2 and 3 were considered the same product (consecutively manufactured, and released with the same product specifications), it was pre-defined to combine AESI data from participants across the three AV7909 lots for AESI relative risk analysis.
Incidence of adverse events of special interest (AESIs; events of autoimmune etiology) from the time of the first vaccination on Day 1 through Day 394 in participants who received at least one dose of AV7909 (Lot 1, Lot 2 or Lot 3) or BioThrax vaccines.
Outcome measures
| Measure |
AV7909 Lot 1
n=1050 Participants
Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 2
n=1053 Participants
Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 3
n=1048 Participants
Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.15 at Day 29.
|
BioThrax
n=533 Participants
Eligible participants randomized to receive BioThrax vaccine.
|
|---|---|---|---|---|
|
Incidence of Adverse Events of Special Interest (Events of Autoimmune Etiology)
|
5 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1-7, Day 15-21, Day 29-35 (within 7 days after each vaccination, inclusive of the vaccination day)Population: Data from participants (solicited systemic reactogenicity events after any vaccination) who received at least one dose of AV7909 vaccine or BioThrax vaccine are included in the analysis.
Incidence of any solicited systemic reactogenicity reaction after any AV7909 or BioThrax vaccination.
Outcome measures
| Measure |
AV7909 Lot 1
n=1050 Participants
Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 2
n=1053 Participants
Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 3
n=1048 Participants
Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.15 at Day 29.
|
BioThrax
n=533 Participants
Eligible participants randomized to receive BioThrax vaccine.
|
|---|---|---|---|---|
|
Incidence of Solicited Systemic Reactogenicity Events
|
885 Participants
|
876 Participants
|
864 Participants
|
414 Participants
|
SECONDARY outcome
Timeframe: Day 1-7, Day 15-21, Day 29-35 (within 7 days after each vaccination, inclusive of the vaccination day)Population: Data from participants who received at least one dose of AV7909 or BioThrax dose are included in the analysis.
Incidence of any solicited injection site reactogenicity reaction after any AV7909 (Lots 1, 2 or 3) or BioThrax vaccination.
Outcome measures
| Measure |
AV7909 Lot 1
n=1050 Participants
Eligible participants who received AV7909 vaccine lot 1 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 2
n=1053 Participants
Eligible participants who received AV7909 vaccine lot 2 and achieved TNA NF50 ≥0.15 at Day 29.
|
AV7909 Lot 3
n=1048 Participants
Eligible participants who received AV7909 vaccine lot 3 and achieved TNA NF50 ≥0.15 at Day 29.
|
BioThrax
n=533 Participants
Eligible participants randomized to receive BioThrax vaccine.
|
|---|---|---|---|---|
|
Incidences of Solicited Injection Site Reactogenicity Events
|
961 Participants
|
961 Participants
|
967 Participants
|
500 Participants
|
Adverse Events
AV7909 Lot 1
Serious events: 21 serious events
Other events: 194 other events
Deaths: 2 deaths
AV7909 Lot 2
Serious events: 16 serious events
Other events: 199 other events
Deaths: 2 deaths
AV7909 Lot 3
Serious events: 21 serious events
Other events: 204 other events
Deaths: 2 deaths
BioThrax
Serious events: 4 serious events
Other events: 171 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AV7909 Lot 1
n=1050 participants at risk
Eligible participants who received at least one dose of AV7909 Lot 1.
|
AV7909 Lot 2
n=1053 participants at risk
Eligible participants who received at least one dose of AV7909 Lot 2.
|
AV7909 Lot 3
n=1048 participants at risk
Eligible participants who received at least one dose of AV7909 Lot 3.
|
BioThrax
n=533 participants at risk
Eligible participants who received at least one dose of BioThrax vaccine.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.19%
1/533 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 2 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Gastrointestinal disorders
Haematemesis
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
General disorders
Death
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
General disorders
Gait disturbance
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 3 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
General disorders
Treatment noncompliance
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Appendicitis
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Cellulitis
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Pneumonia
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.19%
1/533 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Pyelonephritis
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Sepsis
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Vulval abscess
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.19%
1/533 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.19%
2/1048 • Number of events 2 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Nervous system disorders
Headache
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Nervous system disorders
Syncope
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.29%
3/1050 • Number of events 3 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.19%
2/1053 • Number of events 2 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.19%
1/533 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.19%
2/1053 • Number of events 2 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Psychiatric disorders
Dysphemia
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.09%
1/1053 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.10%
1/1048 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Vascular disorders
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.19%
1/533 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis
|
0.00%
0/1050 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1053 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.19%
1/533 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
Other adverse events
| Measure |
AV7909 Lot 1
n=1050 participants at risk
Eligible participants who received at least one dose of AV7909 Lot 1.
|
AV7909 Lot 2
n=1053 participants at risk
Eligible participants who received at least one dose of AV7909 Lot 2.
|
AV7909 Lot 3
n=1048 participants at risk
Eligible participants who received at least one dose of AV7909 Lot 3.
|
BioThrax
n=533 participants at risk
Eligible participants who received at least one dose of BioThrax vaccine.
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
4.4%
46/1050 • Number of events 83 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
5.0%
53/1053 • Number of events 87 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
4.3%
45/1048 • Number of events 78 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
9.2%
49/533 • Number of events 88 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
General disorders
Injection site erythema
|
0.76%
8/1050 • Number of events 9 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.47%
5/1053 • Number of events 5 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.5%
16/1048 • Number of events 19 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
3.2%
17/533 • Number of events 18 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
General disorders
Injection site induration
|
2.3%
24/1050 • Number of events 25 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
2.5%
26/1053 • Number of events 29 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.9%
20/1048 • Number of events 25 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
22.9%
122/533 • Number of events 176 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
General disorders
Injection site swelling
|
0.67%
7/1050 • Number of events 8 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.57%
6/1053 • Number of events 6 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.0%
11/1048 • Number of events 14 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
4.5%
24/533 • Number of events 30 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
General disorders
Injection site warmth
|
0.86%
9/1050 • Number of events 10 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.47%
5/1053 • Number of events 6 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.3%
14/1048 • Number of events 18 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
4.3%
23/533 • Number of events 23 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
General disorders
Injection site bruising
|
1.7%
18/1050 • Number of events 19 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.85%
9/1053 • Number of events 11 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.5%
16/1048 • Number of events 19 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
5.1%
27/533 • Number of events 29 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
General disorders
Injection site pruritus
|
0.95%
10/1050 • Number of events 11 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.76%
8/1053 • Number of events 8 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.3%
14/1048 • Number of events 18 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
7.9%
42/533 • Number of events 49 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
General disorders
Injection site mass
|
0.10%
1/1050 • Number of events 1 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.19%
2/1053 • Number of events 2 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/1048 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.3%
7/533 • Number of events 9 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
27/1050 • Number of events 30 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.76%
8/1053 • Number of events 36 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.95%
10/1048 • Number of events 34 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.1%
6/533 • Number of events 14 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
18/1050 • Number of events 21 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.2%
13/1053 • Number of events 18 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
2.0%
21/1048 • Number of events 23 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.75%
4/533 • Number of events 4 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
12/1050 • Number of events 12 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.76%
8/1053 • Number of events 8 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.95%
10/1048 • Number of events 10 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.1%
6/533 • Number of events 7 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
3.0%
32/1050 • Number of events 35 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
4.0%
42/1053 • Number of events 55 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
3.9%
41/1048 • Number of events 50 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
4.9%
26/533 • Number of events 27 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
2.3%
24/1050 • Number of events 28 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
3.0%
32/1053 • Number of events 43 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
3.0%
31/1048 • Number of events 36 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
4.9%
26/533 • Number of events 30 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Injury, poisoning and procedural complications
Musculoskeletal procedural complication
|
2.7%
28/1050 • Number of events 30 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
3.1%
33/1053 • Number of events 39 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
2.9%
30/1048 • Number of events 36 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
3.6%
19/533 • Number of events 22 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
18/1050 • Number of events 20 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.95%
10/1053 • Number of events 10 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.86%
9/1048 • Number of events 9 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.1%
6/533 • Number of events 6 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Nervous system disorders
Headache
|
1.5%
16/1050 • Number of events 17 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.3%
14/1053 • Number of events 16 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.2%
13/1048 • Number of events 14 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.3%
7/533 • Number of events 8 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Gastrointestinal disorders
Nausea
|
0.86%
9/1050 • Number of events 10 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.1%
12/1053 • Number of events 12 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.86%
9/1048 • Number of events 9 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.38%
2/533 • Number of events 2 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Vascular disorders
Hypertension
|
0.86%
9/1050 • Number of events 9 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.57%
6/1053 • Number of events 6 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.1%
12/1048 • Number of events 12 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.00%
0/533 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.29%
3/1050 • Number of events 3 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.0%
11/1053 • Number of events 11 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.38%
4/1048 • Number of events 4 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.38%
2/533 • Number of events 2 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Psychiatric disorders
Anxiety
|
1.0%
11/1050 • Number of events 11 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.57%
6/1053 • Number of events 6 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.76%
8/1048 • Number of events 9 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.75%
4/533 • Number of events 4 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.48%
5/1050 • Number of events 5 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
1.0%
11/1053 • Number of events 11 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.86%
9/1048 • Number of events 9 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
0.38%
2/533 • Number of events 2 • Day 1 through Day 394.
Adverse events, serious adverse events and adverse events of special interest (events of autoimmune etiology) were collected from Day 1 through Day 394. Local and systemic reactogenicity were solicited for seven days after each vaccination.
|
Additional Information
Bojan Drobic, Director, Clinical Research
Emergent BioSolutions Inc.
Phone: 204 275 4196
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place