Trial Outcomes & Findings for Anthrax AV7909 Liquid vs Lyophilized (NCT NCT04660201)
NCT ID: NCT04660201
Last Updated: 2024-12-19
Results Overview
Serious adverse events (SAEs) included any AE or suspected adverse reaction that, in the view of either the site PI (or appropriate sub-investigator) or sponsor, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect, or may have jeopardized the participant and required medical or surgical intervention to prevent one of the aforementioned outcomes.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Day 1 through Day 380
Results posted on
2024-12-19
Participant Flow
Participants were healthy males and non-pregnant females, 18 to 45 years of age, inclusive, who met all eligibility criteria. They were recruited from the general population at the participating site: University of Maryland, Baltimore. Participants were enrolled between 25May2022 and 09Sep2022.
Participant milestones
| Measure |
Liquid AV7909
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
AV7909 is an investigational vaccine manufactured by Emergent BioSolutions (Emergent) combining the currently licensed Anthrax Vaccine Adsorbed (AVA) with the adjuvant CPG 7909. CPG 7909 is a lyophilized powder manufactured by Avecia Nitto Denko in Milford, MA. CPG 7909's natural deoxyribonucleic acid phosphodiester backbone has been modified to a phosphorothioate backbone, providing the molecule with increased stability and resistance to degradation for improved in vivo activity.
Liquid AV7909 is a preformulated, sterile, milky-white suspension (when mixed) for intramuscular injection.
|
Lyophilized AV7909
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
AV7909 is an investigational vaccine manufactured by Emergent BioSolutions (Emergent) combining the currently licensed Anthrax Vaccine Adsorbed (AVA) with the adjuvant CPG 7909. CPG 7909 is a lyophilized powder manufactured by Avecia Nitto Denko in Milford, MA. CPG 7909's natural deoxyribonucleic acid phosphodiester backbone has been modified to a phosphorothioate backbone, providing the molecule with increased stability and resistance to degradation for improved in vivo activity.
Thermostable AV7909 is a lyophilized version of the liquid AV7909 formulation which, after reconstitution, is a sterile, milky-white suspension for intramuscular injection. The Thermostable AV7909 Bulk Intermediate Product is manufactured at Emergent's Baltimore, MD facility by addition of Polysorbate 80 and CPG7909 adjuvant to AVA Bulk Drug Substance produced by Emergent's Manufacturing facility at Lansing, MI. The Thermostable AV7909 Final Drug Product is manufactured by Integrity Bio Inc.
The AV7909 lyophilized product is mixed with a diluent of United States Pharmacopeia (USP) grade Sterile Water For Injection provided by Fisher BioServices.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anthrax AV7909 Liquid vs Lyophilized
Baseline characteristics by cohort
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
29.3 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Age, Customized
18-30 years old
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Customized
31-45 years old
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Height
|
170.40 cm
STANDARD_DEVIATION 9.36 • n=5 Participants
|
172.09 cm
STANDARD_DEVIATION 9.22 • n=7 Participants
|
171.22 cm
STANDARD_DEVIATION 9.21 • n=5 Participants
|
|
Weight
|
75.79 kg
STANDARD_DEVIATION 17.67 • n=5 Participants
|
75.43 kg
STANDARD_DEVIATION 15.65 • n=7 Participants
|
75.61 kg
STANDARD_DEVIATION 16.51 • n=5 Participants
|
|
BMI
|
25.87 kg/m^2
STANDARD_DEVIATION 4.47 • n=5 Participants
|
25.31 kg/m^2
STANDARD_DEVIATION 3.88 • n=7 Participants
|
25.60 kg/m^2
STANDARD_DEVIATION 4.15 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 380Population: The safety population included all participants who received the first dose of study vaccine.
Serious adverse events (SAEs) included any AE or suspected adverse reaction that, in the view of either the site PI (or appropriate sub-investigator) or sponsor, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was a congenital anomaly/birth defect, or may have jeopardized the participant and required medical or surgical intervention to prevent one of the aforementioned outcomes.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs).
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: The safety population included all participants who received the first dose of study vaccine.
Clinical safety laboratory parameters include blood urea nitrogen (BUN), serum creatinine, alkaline phosphatase, alanine aminotransferase (ALT), total bilirubin, hemoglobin, hemoglobin decrease from baseline, white blood cell (WBC) count, absolute eosinophil count, absolute neutrophil count, platelets, aspartate aminotransferase (AST), random glucose, urine protein, and urine glucose.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Blood urea nitrogen (BUN)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Hemoglobin decrease from baseline
|
3 Participants
|
5 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Absolute neutrophil count
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Creatinine
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Alkaline phosphatase (ALP)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Alanine aminotransferase (ALT)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Total bilirubin
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Hemoglobin
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
White blood cell (WBC) count
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Absolute eosinophil count
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Platelets
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Aspartate aminotransferase (AST)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Random glucose
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Urine protein
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Clinical Safety Laboratory Adverse Events (AEs).
Urine glucose
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 380Population: The safety population included all participants who received the first dose of study vaccine.
Adverse events of special interest (AESIs) in this study were potentially immune-mediated medical conditions (PIMMCs). A list of PIMMCs was provided in the study protocol, including gastrointestinal disorders, liver disorders, metabolic diseases, musculoskeletal disorders, neuroinflammatory disorders, skin disorders, vasculitides, and autoimmune syndromes.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Number of Participants With Protocol-specified Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 380Population: The safety population included all participants who received the first dose of study vaccine.
Adverse events (AEs) characterized by unscheduled medical attention, defined as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason, were designated as medically attended adverse events (MAAEs).
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Number of Participants With Medically Attended Adverse Events (MAAEs).
|
9 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 64Population: The safety population included all participants who received the first dose of study vaccine.
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. The occurrence of an unsolicited AE may have come to the attention of study personnel during study visits and interviews for medical care, or upon review by a study monitor.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Number of Participants With Unsolicited, Non-serious Adverse Events (AEs).
|
14 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Population: The safety population included all participants who received the first dose of study vaccine.
Injection site and systemic reactogenicity events were solicited daily throughout the week following each study vaccination. The number of participants reporting each event on any day following first vaccination is presented. Injection site reactogenicity events included pruritus, ecchymosis, erythema, edema/induration, pain, and tenderness. Systemic reactogenicity events included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Pain
|
19 Participants
|
12 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Tenderness
|
19 Participants
|
20 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Edema/Induration (functional grade)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Fatigue
|
16 Participants
|
13 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Malaise
|
10 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Nausea
|
4 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Pruritus
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Ecchymosis (functional grade)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Ecchymosis (measurement grade)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Erythema (functional grade)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Erythema (measurement grade)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Edema/Induration (measurement grade)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Fever
|
1 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Feverishness
|
5 Participants
|
5 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Myalgia
|
11 Participants
|
6 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Arthralgia
|
5 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following First Study Vaccination.
Headache
|
10 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Day 15 through Day 22Population: The safety population included all participants who received the first dose of study vaccine.
Injection site and systemic reactogenicity events were solicited daily throughout the week following each study vaccination. The number of participants reporting each event on any day following second vaccination is presented. Injection site reactogenicity events included pruritus, ecchymosis, erythema, edema/induration, pain, and tenderness. Systemic reactogenicity events included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Ecchymosis (functional grade)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Malaise
|
10 Participants
|
10 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Nausea
|
5 Participants
|
6 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Pain
|
16 Participants
|
13 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Tenderness
|
20 Participants
|
19 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Pruritus
|
3 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Ecchymosis (measurement grade)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Erythema (functional grade)
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Erythema (measurement grade)
|
3 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Edema/Induration (functional grade)
|
2 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Edema/Induration (measurement grade)
|
2 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Fever
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Feverishness
|
11 Participants
|
8 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Fatigue
|
16 Participants
|
13 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Myalgia
|
10 Participants
|
10 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Arthralgia
|
5 Participants
|
6 Participants
|
|
Number of Participants With Solicited Injection Site and Systemic Reactogenicity Events Following Second Study Vaccination.
Headache
|
14 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 15, Day 22, Day 29, Day 64, Day 195, and Day 380Population: The modified intent-to-treat (mITT) population included all randomized participants who received the first dose of study vaccine and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Serum for toxin neutralization assay (TNA) was collected at Days 1, 8, 15, 22, 29, 64, 195, and 380. The TNA assay measures the functional ability of antisera containing anti-PA antibodies to specifically protect cells against B. anthracis lethal toxin cytotoxicity. TNA assay results were reported as the reciprocal titer of a serum sample dilution that results in 50% neutralization of lethal toxin cytotoxicity, which is referred to as 50% effective dilution (ED50). To standardize assay results, the results were divided by the ED50 of a serum reference standard, AVR801, and the resulting ratio was reported as a 50% neutralization factor (NF50). Individual results below the lower limit of quantification (LLOQ) for the assay were imputed as 1/2 x LLOQ; the LLOQ for TNA ED50 is 33, so individual results \<33 were imputed to 16.5. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution).
Day 1
|
16.5 titer
95% CI was not estimable because all values were below the lower limit of quantification (LLOQ) and imputed to 1/2 x LLOQ.
|
17.2 titer
Interval 15.7 to 18.8
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution).
Day 8
|
16.5 titer
95% CI was not estimable because all values were below the lower limit of quantification (LLOQ) and imputed to 1/2 x LLOQ.
|
22.6 titer
Interval 11.7 to 43.5
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution).
Day 15
|
21.1 titer
Interval 14.8 to 30.0
|
26.6 titer
Interval 12.9 to 54.7
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution).
Day 22
|
361.8 titer
Interval 229.2 to 570.9
|
459.9 titer
Interval 273.7 to 772.9
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution).
Day 29
|
765.9 titer
Interval 572.6 to 1024.6
|
1007.7 titer
Interval 636.6 to 1595.0
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution).
Day 64
|
392.5 titer
Interval 297.4 to 517.9
|
496.5 titer
Interval 312.5 to 788.8
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution).
Day 195
|
97.3 titer
Interval 61.8 to 153.0
|
127.1 titer
Interval 76.2 to 212.2
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution).
Day 380
|
76.3 titer
Interval 47.1 to 123.6
|
103.5 titer
Interval 56.3 to 190.4
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 15, Day 22, Day 29, Day 64, Day 195, and Day 380Population: The modified intent-to-treat (mITT) population included all randomized participants who received the first dose of study vaccine and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Serum for toxin neutralization assay (TNA) was collected at Days 1, 8, 15, 22, 29, 64, 195, and 380. The TNA assay measures the functional ability of antisera containing anti-PA antibodies to specifically protect cells against B. anthracis lethal toxin cytotoxicity. TNA assay results were reported as the reciprocal titer of a serum sample dilution that results in 50% neutralization of lethal toxin cytotoxicity, which is referred to as 50% effective dilution (ED50). To standardize assay results, the results were divided by the ED50 of a serum reference standard, AVR801, and the resulting ratio was reported as a 50% neutralization factor (NF50). Individual results below the lower limit of quantification (LLOQ) for the assay were imputed as 1/2 x LLOQ; the LLOQ for TNA NF50 is 0.064, so individual results \<0.064 were imputed to 0.032. The geometric mean titer (GMT) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor).
Day 1
|
0.0320 titer
95% CI was not estimable because all values were below the lower limit of quantification (LLOQ) and imputed to 1/2 x LLOQ.
|
0.0336 titer
Interval 0.0303 to 0.0373
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor).
Day 8
|
0.0320 titer
95% CI was not estimable because all values were below the lower limit of quantification (LLOQ) and imputed to 1/2 x LLOQ.
|
0.0440 titer
Interval 0.0226 to 0.0855
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor).
Day 15
|
0.0416 titer
Interval 0.0285 to 0.0605
|
0.0524 titer
Interval 0.0251 to 0.1093
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor).
Day 22
|
0.7793 titer
Interval 0.4938 to 1.2297
|
0.9394 titer
Interval 0.5559 to 1.5876
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor).
Day 29
|
1.6211 titer
Interval 1.2078 to 2.1759
|
2.0862 titer
Interval 1.3158 to 3.3077
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor).
Day 64
|
0.8215 titer
Interval 0.6148 to 1.0979
|
1.0668 titer
Interval 0.6823 to 1.6681
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor).
Day 195
|
0.2318 titer
Interval 0.1431 to 0.3753
|
0.3027 titer
Interval 0.1854 to 0.4942
|
|
Geometric Mean Titer (GMT) and 95% Confidence Interval (CI) of TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor).
Day 380
|
0.1885 titer
Interval 0.1182 to 0.3007
|
0.2467 titer
Interval 0.1307 to 0.4654
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 15, Day 22, Day 29, Day 64, Day 195, and Day 380Population: The modified intent-to-treat (mITT) population included all randomized participants who received the first dose of study vaccine and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Serum for anti-PA IgG Enzyme Linked ImmunoSorbent Assay (ELISA) was collected at Days 1, 8, 15, 22, 29, 64, 195, and 380. Individual anti-PA IgG concentrations were reported in µg/mL. Individual results below the lower limit of quantification (LLOQ) for the assay were imputed as 1/2 x LLOQ; the LLOQ for this assay is 9.27 µg/mL, so individual results \<9.27 µg/mL were imputed to 4.635 µg/mL. The geometric mean concentration (GMC) across samples was calculated within each study arm and analysis time point.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Geometric Mean Concentration (GMC) and 95% Confidence Interval (CI) of Anti-PA IgG (Anti-protective Antigen Immunoglobulin G)
Day 1
|
4.6350 concentration (µg/mL)
95% CI was not estimable because all values were below the lower limit of quantification (LLOQ) and imputed to 1/2 x LLOQ.
|
4.6350 concentration (µg/mL)
95% CI was not estimable because all values were below the lower limit of quantification (LLOQ) and imputed to 1/2 x LLOQ.
|
|
Geometric Mean Concentration (GMC) and 95% Confidence Interval (CI) of Anti-PA IgG (Anti-protective Antigen Immunoglobulin G)
Day 8
|
4.6350 concentration (µg/mL)
95% CI was not estimable because all values were below the lower limit of quantification (LLOQ) and imputed to 1/2 x LLOQ.
|
5.9485 concentration (µg/mL)
Interval 3.5287 to 10.0275
|
|
Geometric Mean Concentration (GMC) and 95% Confidence Interval (CI) of Anti-PA IgG (Anti-protective Antigen Immunoglobulin G)
Day 15
|
5.6453 concentration (µg/mL)
Interval 4.0969 to 7.7789
|
6.4408 concentration (µg/mL)
Interval 3.5454 to 11.7006
|
|
Geometric Mean Concentration (GMC) and 95% Confidence Interval (CI) of Anti-PA IgG (Anti-protective Antigen Immunoglobulin G)
Day 22
|
174.8605 concentration (µg/mL)
Interval 105.2301 to 290.5648
|
99.1012 concentration (µg/mL)
Interval 62.7645 to 156.4745
|
|
Geometric Mean Concentration (GMC) and 95% Confidence Interval (CI) of Anti-PA IgG (Anti-protective Antigen Immunoglobulin G)
Day 29
|
342.9604 concentration (µg/mL)
Interval 253.8561 to 463.3407
|
242.9552 concentration (µg/mL)
Interval 172.6733 to 341.8433
|
|
Geometric Mean Concentration (GMC) and 95% Confidence Interval (CI) of Anti-PA IgG (Anti-protective Antigen Immunoglobulin G)
Day 64
|
159.5296 concentration (µg/mL)
Interval 121.2712 to 209.8577
|
126.1505 concentration (µg/mL)
Interval 85.409 to 186.3263
|
|
Geometric Mean Concentration (GMC) and 95% Confidence Interval (CI) of Anti-PA IgG (Anti-protective Antigen Immunoglobulin G)
Day 195
|
27.9235 concentration (µg/mL)
Interval 19.4916 to 40.0029
|
22.3319 concentration (µg/mL)
Interval 13.3216 to 37.4364
|
|
Geometric Mean Concentration (GMC) and 95% Confidence Interval (CI) of Anti-PA IgG (Anti-protective Antigen Immunoglobulin G)
Day 380
|
14.9907 concentration (µg/mL)
Interval 9.211 to 24.3973
|
14.3207 concentration (µg/mL)
Interval 7.9131 to 25.917
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 29, Day 64, Day 195, and Day 380Population: The modified intent-to-treat (mITT) population included all randomized participants who received the first dose of study vaccine and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Serum for toxin neutralization assay (TNA) was collected at Days 1, 8, 15, 22, 29, 64, 195, and 380. The TNA assay measures the functional ability of antisera containing anti-PA antibodies to specifically protect cells against B. anthracis lethal toxin cytotoxicity. TNA assay results were reported as the reciprocal titer of a serum sample dilution that results in 50% neutralization of lethal toxin cytotoxicity, which is referred to as 50% effective dilution (ED50). To standardize assay results, the results were divided by the ED50 of a serum reference standard, AVR801, and the resulting ratio was reported as a 50% neutralization factor (NF50). Seroconversion was defined as at least a 4-fold increase over baseline result, or at least a 4-fold increase over the lower limit of quantification (LLOQ) if baseline result is below LLOQ.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution) Seroconversion.
Day 380
|
37 percentage of participants
Interval 16.0 to 62.0
|
39 percentage of participants
Interval 17.0 to 64.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution) Seroconversion.
Day 195
|
35 percentage of participants
Interval 15.0 to 59.0
|
35 percentage of participants
Interval 15.0 to 59.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution) Seroconversion.
Day 8
|
0 percentage of participants
Interval 0.0 to 16.0
|
5 percentage of participants
Interval 0.0 to 25.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution) Seroconversion.
Day 15
|
10 percentage of participants
Interval 1.0 to 30.0
|
5 percentage of participants
Interval 0.0 to 25.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution) Seroconversion.
Day 22
|
86 percentage of participants
Interval 64.0 to 97.0
|
85 percentage of participants
Interval 62.0 to 97.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution) Seroconversion.
Day 29
|
100 percentage of participants
Interval 84.0 to 100.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA ED50 (Toxin Neutralization Assay 50% Effective Dilution) Seroconversion.
Day 64
|
100 percentage of participants
Interval 83.0 to 100.0
|
90 percentage of participants
Interval 68.0 to 99.0
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 29, Day 64, Day 195, and Day 380Population: The modified intent-to-treat (mITT) population included all randomized participants who received the first dose of study vaccine and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Serum for toxin neutralization assay (TNA) was collected at Days 1, 8, 15, 22, 29, 64, 195, and 380. The TNA assay measures the functional ability of antisera containing anti-PA antibodies to specifically protect cells against B. anthracis lethal toxin cytotoxicity. TNA assay results were reported as the reciprocal titer of a serum sample dilution that results in 50% neutralization of lethal toxin cytotoxicity, which is referred to as 50% effective dilution (ED50). To standardize assay results, the results were divided by the ED50 of a serum reference standard, AVR801, and the resulting ratio was reported as a 50% neutralization factor (NF50). Seroconversion was defined as at least a 4-fold increase over baseline result, or at least a 4-fold increase over the lower limit of quantification (LLOQ) if baseline result is below LLOQ.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor) Seroconversion.
Day 15
|
10 percentage of participants
Interval 1.0 to 30.0
|
10 percentage of participants
Interval 1.0 to 32.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor) Seroconversion.
Day 8
|
0 percentage of participants
Interval 0.0 to 16.0
|
5 percentage of participants
Interval 0.0 to 25.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor) Seroconversion.
Day 22
|
86 percentage of participants
Interval 64.0 to 97.0
|
85 percentage of participants
Interval 62.0 to 97.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor) Seroconversion.
Day 29
|
100 percentage of participants
Interval 84.0 to 100.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor) Seroconversion.
Day 64
|
100 percentage of participants
Interval 83.0 to 100.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor) Seroconversion.
Day 195
|
45 percentage of participants
Interval 23.0 to 68.0
|
50 percentage of participants
Interval 27.0 to 73.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving TNA NF50 (Toxin Neutralization Assay 50% Neutralization Factor) Seroconversion.
Day 380
|
47 percentage of participants
Interval 24.0 to 71.0
|
44 percentage of participants
Interval 22.0 to 69.0
|
SECONDARY outcome
Timeframe: Day 8, Day 15, Day 22, Day 29, Day 64, Day 195, and Day 380Population: The modified intent-to-treat (mITT) population included all randomized participants who received the first dose of study vaccine and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Serum for anti-PA IgG Enzyme Linked ImmunoSorbent Assay (ELISA) was collected at Days 1, 8, 15, 22, 29, 64, 195, and 380. Individual anti-PA IgG concentrations were reported in µg/mL. Seroconversion was defined as at least a 4-fold increase over baseline result, or at least a 4-fold increase over the lower limit of quantification (LLOQ) if baseline result is below LLOQ.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Anti-PA IgG (Anti-protective Antigen Immunoglobulin G) Seroconversion.
Day 8
|
0 percentage of participants
Interval 0.0 to 16.0
|
5 percentage of participants
Interval 0.0 to 25.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Anti-PA IgG (Anti-protective Antigen Immunoglobulin G) Seroconversion.
Day 15
|
5 percentage of participants
Interval 0.0 to 24.0
|
5 percentage of participants
Interval 0.0 to 25.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Anti-PA IgG (Anti-protective Antigen Immunoglobulin G) Seroconversion.
Day 22
|
86 percentage of participants
Interval 64.0 to 97.0
|
85 percentage of participants
Interval 62.0 to 97.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Anti-PA IgG (Anti-protective Antigen Immunoglobulin G) Seroconversion.
Day 29
|
100 percentage of participants
Interval 84.0 to 100.0
|
100 percentage of participants
Interval 83.0 to 100.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Anti-PA IgG (Anti-protective Antigen Immunoglobulin G) Seroconversion.
Day 64
|
100 percentage of participants
Interval 83.0 to 100.0
|
95 percentage of participants
Interval 75.0 to 100.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Anti-PA IgG (Anti-protective Antigen Immunoglobulin G) Seroconversion.
Day 195
|
30 percentage of participants
Interval 12.0 to 54.0
|
25 percentage of participants
Interval 9.0 to 49.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Anti-PA IgG (Anti-protective Antigen Immunoglobulin G) Seroconversion.
Day 380
|
21 percentage of participants
Interval 6.0 to 46.0
|
17 percentage of participants
Interval 4.0 to 41.0
|
SECONDARY outcome
Timeframe: Day 1, Day 8, Day 15, Day 22, Day 29, Day 64, Day 195, and Day 380Population: The modified intent-to-treat (mITT) population included all randomized participants who received the first dose of study vaccine and contributed at least one post-first study vaccination venous blood sample for immunogenicity testing for which valid results were reported.
Serum for toxin neutralization assay (TNA) was collected at Days 1, 8, 15, 22, 29, 64, 195, and 380. The TNA assay measures the functional ability of antisera containing anti-PA antibodies to specifically protect cells against B. anthracis lethal toxin cytotoxicity. TNA assay results were reported as the reciprocal titer of a serum sample dilution that results in 50% neutralization of lethal toxin cytotoxicity, which is referred to as 50% effective dilution (ED50). To standardize assay results, the results were divided by the ED50 of a serum reference standard, AVR801, and the resulting ratio was reported as a 50% neutralization factor (NF50). Putative seroprotection was defined as TNA NF50 = 0.56.
Outcome measures
| Measure |
Liquid AV7909
n=21 Participants
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 Participants
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Putative Seroprotection (TNA NF50 = 0.56).
Day 1
|
0 percentage of participants
Interval 0.0 to 16.0
|
0 percentage of participants
Interval 0.0 to 17.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Putative Seroprotection (TNA NF50 = 0.56).
Day 8
|
0 percentage of participants
Interval 0.0 to 16.0
|
5 percentage of participants
Interval 0.0 to 25.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Putative Seroprotection (TNA NF50 = 0.56).
Day 15
|
5 percentage of participants
Interval 0.0 to 24.0
|
5 percentage of participants
Interval 0.0 to 25.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Putative Seroprotection (TNA NF50 = 0.56).
Day 22
|
76 percentage of participants
Interval 53.0 to 92.0
|
65 percentage of participants
Interval 41.0 to 85.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Putative Seroprotection (TNA NF50 = 0.56).
Day 29
|
100 percentage of participants
Interval 84.0 to 100.0
|
85 percentage of participants
Interval 62.0 to 97.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Putative Seroprotection (TNA NF50 = 0.56).
Day 64
|
65 percentage of participants
Interval 41.0 to 85.0
|
85 percentage of participants
Interval 62.0 to 97.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Putative Seroprotection (TNA NF50 = 0.56).
Day 195
|
25 percentage of participants
Interval 9.0 to 49.0
|
30 percentage of participants
Interval 12.0 to 54.0
|
|
Percentage and 95% Confidence Interval (CI) of Participants Achieving Putative Seroprotection (TNA NF50 = 0.56).
Day 380
|
11 percentage of participants
Interval 1.0 to 33.0
|
33 percentage of participants
Interval 13.0 to 59.0
|
Adverse Events
Liquid AV7909
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Lyophilized AV7909
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Liquid AV7909
n=21 participants at risk
AV7909 liquid product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
Lyophilized AV7909
n=20 participants at risk
AV7909 thermostable lyophilized product administered intramuscularly in a 2-dose schedule, 2 weeks apart (Day 1 and Day 15).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
7/21 • Number of events 9 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
40.0%
8/20 • Number of events 9 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
General disorders
Fatigue
|
85.7%
18/21 • Number of events 32 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
70.0%
14/20 • Number of events 26 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
General disorders
Injection site erythema
|
19.0%
4/21 • Number of events 4 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
15.0%
3/20 • Number of events 4 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
General disorders
Injection site haemorrhage
|
14.3%
3/21 • Number of events 3 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
15.0%
3/20 • Number of events 4 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
General disorders
Injection site induration
|
19.0%
4/21 • Number of events 4 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
30.0%
6/20 • Number of events 6 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
General disorders
Injection site pain
|
100.0%
21/21 • Number of events 41 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
100.0%
20/20 • Number of events 39 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
General disorders
Injection site pruritus
|
14.3%
3/21 • Number of events 5 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
10.0%
2/20 • Number of events 2 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
General disorders
Malaise
|
66.7%
14/21 • Number of events 20 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
55.0%
11/20 • Number of events 14 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
General disorders
Pyrexia
|
57.1%
12/21 • Number of events 16 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
50.0%
10/20 • Number of events 13 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Infections and infestations
COVID-19
|
19.0%
4/21 • Number of events 4 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
15.0%
3/20 • Number of events 3 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Infections and infestations
Influenza
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Infections and infestations
Otitis media
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
4.8%
1/21 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 2 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Investigations
Blood glucose increased
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Investigations
Haemoglobin decreased
|
19.0%
4/21 • Number of events 4 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
30.0%
6/20 • Number of events 6 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
38.1%
8/21 • Number of events 11 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
35.0%
7/20 • Number of events 8 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
14/21 • Number of events 21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
50.0%
10/20 • Number of events 16 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Nervous system disorders
Headache
|
85.7%
18/21 • Number of events 25 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
70.0%
14/20 • Number of events 20 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
10.0%
2/20 • Number of events 2 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/21 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
5.0%
1/20 • Number of events 1 • Reactogenicity was solicited from each study vaccination through Day 8 after vaccination. Unsolicited non-serious adverse events (AEs) were reported from first study vaccination through approximately Day 64. Serious adverse events (SAEs), medically attended adverse events (MAAEs), and adverse events of special interest (AESIs) were collected from first study vaccination through approximately Day 380. Clinical safety laboratory evaluations were performed at approximately Day 29.
|
Additional Information
James Campbell, MD
University of Maryland School of Medicine
Phone: 410-706-5328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place