Trial Outcomes & Findings for BARDA Securing Anthrax Immunity For the Elderly (NCT NCT03518125)
NCT ID: NCT03518125
Last Updated: 2020-07-21
Results Overview
Count of participants who experienced at least one of the following during the time frame specified on the arm which received the vaccination: injection site warmth, tenderness, itching, pain, restriction of range of arm motion, erythema/redness, palpable or observable lump, induration/swelling, or bruising.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
305 participants
Primary outcome timeframe
Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)
Results posted on
2020-07-21
Participant Flow
469 participants were screened at 4 sites in the US between May 14, 2018 - November 8, 2018, of which 305 were randomized and vaccinated between May 17, 2018 - November 12, 2018.
Participant milestones
| Measure |
Age ≥ 66 Years: BioThrax (Day 1, Day 15, and Day 29)
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Days 1, Day 15) With Placebo (Day 29)
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
49
|
52
|
52
|
52
|
|
Overall Study
COMPLETED
|
48
|
46
|
49
|
51
|
48
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
0
|
1
|
4
|
8
|
Reasons for withdrawal
| Measure |
Age ≥ 66 Years: BioThrax (Day 1, Day 15, and Day 29)
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Days 1, Day 15) With Placebo (Day 29)
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
0
|
3
|
5
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
1
|
3
|
|
Overall Study
Missed Day 394 Visit
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
BARDA Securing Anthrax Immunity For the Elderly
Baseline characteristics by cohort
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=50 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=50 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=49 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=52 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Total
n=305 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
102 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
201 Participants
n=8 Participants
|
|
Age, Continuous
|
72.7 years
STANDARD_DEVIATION 5.89 • n=5 Participants
|
71.2 years
STANDARD_DEVIATION 4.76 • n=7 Participants
|
72.8 years
STANDARD_DEVIATION 4.88 • n=5 Participants
|
72.5 years
STANDARD_DEVIATION 5.04 • n=4 Participants
|
33.5 years
STANDARD_DEVIATION 9.46 • n=21 Participants
|
33.7 years
STANDARD_DEVIATION 9.55 • n=8 Participants
|
59.1 years
STANDARD_DEVIATION 19.63 • n=8 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
173 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
132 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
48 Participants
n=8 Participants
|
294 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
277 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
49 participants
n=5 Participants
|
52 participants
n=4 Participants
|
52 participants
n=21 Participants
|
52 participants
n=8 Participants
|
305 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)Population: Safety population includes all randomized participants who received any amount of study vaccination.
Count of participants who experienced at least one of the following during the time frame specified on the arm which received the vaccination: injection site warmth, tenderness, itching, pain, restriction of range of arm motion, erythema/redness, palpable or observable lump, induration/swelling, or bruising.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=50 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=50 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=49 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=52 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Solicited Local Reactogenicity Symptoms
|
46 Participants
|
43 Participants
|
40 Participants
|
45 Participants
|
50 Participants
|
50 Participants
|
PRIMARY outcome
Timeframe: Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)Population: Safety population includes all randomized participants who received any amount of study vaccination.
Count of participants who experienced at least one of the following during the time frame specified on the arm which received the vaccination: fatigue, myalgia/muscle ache, headache, and fever.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=50 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=50 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=49 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=52 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Solicited Systemic Reactogenicity Symptoms
|
14 Participants
|
23 Participants
|
18 Participants
|
20 Participants
|
15 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: Day 64Population: Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
The percentage of participants achieving seroprotection based on TNA NF50. A 70% probability of survival was associated with a TNA NF50 level of 0.56 in rabbits exposed to Bacillus anthracis, the bacteria that causes anthrax.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=41 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=39 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=42 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=38 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Seroprotection Based on Toxin Neutralization Antibody (TNA) 50% Neutralization Factor (NF50) Antibody Level, Defined as a TNA NF50 Antibody Level ≥0.56
|
7 Participants
|
37 Participants
|
19 Participants
|
40 Participants
|
22 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 394Population: Safety population includes all randomized participants who received any amount of study vaccination.
The count of participants who experienced at least one post-vaccination unsolicited AE (i.e. AEs not included in the solicited local and systemic adverse event list through Day 50 and those reported as a serious AE, medically attended adverse event (MAAE), or potentially immune-mediated medical condition (PIMMC) after Day 50).
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=50 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=50 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=49 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=52 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Treatment-emergent Unsolicited Adverse Events (AEs)
|
41 Participants
|
34 Participants
|
32 Participants
|
39 Participants
|
30 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 394Population: Safety population includes all randomized participants who received any amount of study vaccination.
The count of participants who experienced at least one post-vaccination SAE
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=50 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=50 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=49 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=52 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Treatment-emergent Serious Adverse Events (SAEs)
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 394Population: Safety population includes all randomized participants who received any amount of study vaccination.
Count of participants who experienced at least one adverse event that requires a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring post-vaccination.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=50 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=50 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=49 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=52 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Treatment-emergent Medically Attended Adverse Events (MAAEs)
|
27 Participants
|
23 Participants
|
21 Participants
|
23 Participants
|
13 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 1 through Day 394Population: Safety population includes all randomized participants who received any amount of study vaccination.
Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=50 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=50 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=49 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=52 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)Population: Safety population includes all randomized participants who received any amount of study vaccination.
Count of participants who experienced at least one of the following during the time frame specified on the arm which did not receive the vaccination: injection site warmth, tenderness, itching, pain, restriction of range of arm motion, erythema/redness, palpable or observable lump, induration/swelling, or bruising.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=50 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=50 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=49 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=52 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=52 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Solicited Local Reactogenicity Symptoms on the Contralateral Arm
|
11 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394Population: Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
A higher TNA NF50 antibody level means a better immune response to the vaccine.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=41 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=39 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=42 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=38 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
TNA NF50 Antibody Levels
Day 1
|
.03 Titers
Interval 0.03 to 0.03
|
.03 Titers
Interval 0.03 to 0.03
|
.03 Titers
Interval 0.03 to 0.03
|
.03 Titers
Interval 0.03 to 0.03
|
.03 Titers
Interval 0.03 to 0.03
|
.03 Titers
Interval 0.03 to 0.03
|
|
TNA NF50 Antibody Levels
Day 8
|
.03 Titers
Interval 0.03 to 0.03
|
.03 Titers
Interval 0.03 to 0.03
|
.03 Titers
Interval 0.03 to 0.03
|
.03 Titers
Interval 0.03 to 0.03
|
.03 Titers
Interval 0.03 to 0.04
|
.03 Titers
Interval 0.03 to 0.03
|
|
TNA NF50 Antibody Levels
Day 22
|
.04 Titers
Interval 0.03 to 0.05
|
.25 Titers
Interval 0.14 to 0.45
|
.23 Titers
Interval 0.14 to 0.39
|
.10 Titers
Interval 0.07 to 0.14
|
.08 Titers
Interval 0.05 to 0.11
|
.67 Titers
Interval 0.48 to 0.95
|
|
TNA NF50 Antibody Levels
Day 29
|
.11 Titers
Interval 0.07 to 0.16
|
.77 Titers
Interval 0.49 to 1.2
|
.80 Titers
Interval 0.54 to 1.17
|
.12 Titers
Interval 0.08 to 0.16
|
.43 Titers
Interval 0.3 to 0.63
|
1.02 Titers
Interval 0.8 to 1.31
|
|
TNA NF50 Antibody Levels
Day 36
|
.36 Titers
Interval 0.25 to 0.52
|
2.92 Titers
Interval 1.9 to 4.48
|
.75 Titers
Interval 0.5 to 1.11
|
2.98 Titers
Interval 2.08 to 4.27
|
.84 Titers
Interval 0.6 to 1.16
|
1.06 Titers
Interval 0.82 to 1.38
|
|
TNA NF50 Antibody Levels
Day 43
|
.55 Titers
Interval 0.45 to 0.68
|
4.26 Titers
Interval 3.2 to 5.66
|
.69 Titers
Interval 0.47 to 1.02
|
6.73 Titers
Interval 5.19 to 8.72
|
.94 Titers
Interval 0.73 to 1.21
|
.94 Titers
Interval 0.72 to 1.21
|
|
TNA NF50 Antibody Levels
Day 50
|
.45 Titers
Interval 0.36 to 0.56
|
3.38 Titers
Interval 2.58 to 4.43
|
.60 Titers
Interval 0.41 to 0.88
|
5.30 Titers
Interval 4.12 to 6.81
|
.79 Titers
Interval 0.61 to 1.03
|
.84 Titers
Interval 0.64 to 1.1
|
|
TNA NF50 Antibody Levels
Day 64
|
.32 Titers
Interval 0.25 to 0.41
|
2.36 Titers
Interval 1.83 to 3.06
|
.44 Titers
Interval 0.29 to 0.64
|
3.42 Titers
Interval 2.63 to 4.43
|
.59 Titers
Interval 0.45 to 0.78
|
.69 Titers
Interval 0.53 to 0.89
|
|
TNA NF50 Antibody Levels
Day 85
|
.20 Titers
Interval 0.15 to 0.26
|
1.48 Titers
Interval 1.17 to 1.87
|
.30 Titers
Interval 0.2 to 0.45
|
2.08 Titers
Interval 1.59 to 2.71
|
.42 Titers
Interval 0.3 to 0.59
|
.53 Titers
Interval 0.4 to 0.7
|
|
TNA NF50 Antibody Levels
Day 181
|
.05 Titers
Interval 0.04 to 0.07
|
.37 Titers
Interval 0.28 to 0.48
|
.12 Titers
Interval 0.09 to 0.17
|
.34 Titers
Interval 0.24 to 0.46
|
.12 Titers
Interval 0.08 to 0.16
|
.23 Titers
Interval 0.17 to 0.32
|
|
TNA NF50 Antibody Levels
Day 394
|
.04 Titers
Interval 0.03 to 0.04
|
.14 Titers
Interval 0.1 to 0.2
|
.10 Titers
Interval 0.07 to 0.13
|
.09 Titers
Interval 0.07 to 0.12
|
.05 Titers
Interval 0.04 to 0.07
|
.16 Titers
Interval 0.11 to 0.23
|
SECONDARY outcome
Timeframe: Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394Population: Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
A higher TNA ED50 antibody level means a better immune response to the vaccine.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=41 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=39 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=42 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=38 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Day 1
|
16.5 Titers
Interval 16.5 to 16.5
|
16.5 Titers
Interval 16.5 to 16.5
|
16.5 Titers
Interval 16.5 to 16.5
|
16.5 Titers
Interval 16.5 to 16.5
|
16.5 Titers
Interval 16.5 to 16.5
|
16.5 Titers
Interval 16.5 to 16.5
|
|
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Day 8
|
16.5 Titers
Interval 16.5 to 16.5
|
16.5 Titers
Interval 16.5 to 16.5
|
16.5 Titers
Interval 16.5 to 16.5
|
16.5 Titers
Interval 16.5 to 16.5
|
17.18 Titers
Interval 15.83 to 18.66
|
16.5 Titers
Interval 16.5 to 16.5
|
|
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Day 22
|
20.13 Titers
Interval 16.84 to 24.06
|
136.20 Titers
Interval 77.04 to 240.78
|
122.26 Titers
Interval 73.04 to 204.66
|
52.24 Titers
Interval 35.89 to 76.03
|
35.66 Titers
Interval 24.05 to 52.87
|
322.78 Titers
Interval 228.43 to 456.1
|
|
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Day 29
|
54.88 Titers
Interval 36.12 to 83.36
|
410.47 Titers
Interval 263.48 to 639.47
|
411.94 Titers
Interval 280.68 to 604.59
|
63.02 Titers
Interval 44.68 to 88.88
|
208.90 Titers
Interval 144.37 to 302.28
|
501.88 Titers
Interval 391.96 to 642.64
|
|
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Day 36
|
187.97 Titers
Interval 130.74 to 270.25
|
1557.95 Titers
Interval 1030.38 to 2355.64
|
389.79 Titers
Interval 262.37 to 579.07
|
1548.57 Titers
Interval 1102.91 to 2174.32
|
410.11 Titers
Interval 297.17 to 565.97
|
519.81 Titers
Interval 397.84 to 679.18
|
|
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Day 43
|
299.59 Titers
Interval 243.47 to 368.64
|
2135.14 Titers
Interval 1605.51 to 2839.48
|
361.30 Titers
Interval 245.67 to 531.35
|
3490.12 Titers
Interval 2737.94 to 4448.95
|
495.07 Titers
Interval 386.91 to 633.48
|
497.77 Titers
Interval 384.03 to 645.2
|
|
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Day 50
|
250.88 Titers
Interval 201.26 to 312.73
|
1658.94 Titers
Interval 1265.22 to 2175.19
|
315.10 Titers
Interval 214.65 to 462.54
|
2600.22 Titers
Interval 2035.57 to 3321.51
|
414.59 Titers
Interval 317.69 to 541.06
|
435.56 Titers
Interval 331.22 to 572.77
|
|
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Day 64
|
184.31 Titers
Interval 145.92 to 232.8
|
1240.66 Titers
Interval 976.7 to 1575.97
|
248.04 Titers
Interval 168.46 to 365.21
|
1771.46 Titers
Interval 1386.67 to 2263.02
|
321.15 Titers
Interval 241.54 to 427.0
|
363.05 Titers
Interval 279.48 to 471.62
|
|
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Day 85
|
85.20 Titers
Interval 63.6 to 114.11
|
650.14 Titers
Interval 511.93 to 825.65
|
136.72 Titers
Interval 93.76 to 199.38
|
902.39 Titers
Interval 689.72 to 1180.63
|
181.14 Titers
Interval 130.24 to 251.92
|
224.09 Titers
Interval 171.05 to 293.57
|
|
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Day 181
|
25.55 Titers
Interval 20.08 to 32.51
|
163.46 Titers
Interval 124.59 to 214.46
|
55.87 Titers
Interval 40.37 to 77.31
|
151.24 Titers
Interval 111.24 to 205.61
|
55.17 Titers
Interval 39.33 to 77.39
|
108.67 Titers
Interval 80.46 to 146.78
|
|
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
Day 394
|
18.29 Titers
Interval 16.52 to 20.24
|
74.48 Titers
Interval 52.5 to 105.68
|
49.63 Titers
Interval 35.44 to 69.49
|
50.29 Titers
Interval 37.22 to 67.97
|
27.46 Titers
Interval 20.16 to 37.39
|
76.66 Titers
Interval 52.84 to 111.21
|
SECONDARY outcome
Timeframe: Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394Population: Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
A higher ELISA anti-PA IgG antibody level means a better immune response to the vaccine.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=41 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=39 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=42 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=38 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Day 1
|
4.64 Titers
Interval 4.64 to 4.64
|
4.78 Titers
Interval 4.49 to 5.09
|
4.64 Titers
Interval 4.64 to 4.64
|
4.91 Titers
Interval 4.51 to 5.34
|
4.64 Titers
Interval 4.64 to 4.64
|
4.64 Titers
Interval 4.64 to 4.64
|
|
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Day 8
|
4.64 Titers
Interval 4.64 to 4.64
|
4.77 Titers
Interval 4.5 to 5.07
|
4.64 Titers
Interval 4.64 to 4.64
|
4.96 Titers
Interval 4.49 to 5.48
|
4.78 Titers
Interval 4.49 to 5.09
|
4.64 Titers
Interval 4.64 to 4.64
|
|
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Day 22
|
6.06 Titers
Interval 4.78 to 7.68
|
37.28 Titers
Interval 22.32 to 62.27
|
40.33 Titers
Interval 25.68 to 63.36
|
10.26 Titers
Interval 7.19 to 14.62
|
19.61 Titers
Interval 12.91 to 29.77
|
80.66 Titers
Interval 58.31 to 111.57
|
|
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Day 29
|
29.84 Titers
Interval 19.12 to 46.58
|
124.04 Titers
Interval 84.6 to 181.85
|
138.17 Titers
Interval 97.23 to 196.34
|
11.98 Titers
Interval 8.29 to 17.31
|
106.64 Titers
Interval 75.8 to 150.02
|
139.82 Titers
Interval 112.5 to 173.79
|
|
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Day 36
|
75.98 Titers
Interval 52.39 to 110.2
|
347.86 Titers
Interval 243.34 to 497.29
|
134.15 Titers
Interval 94.1 to 191.25
|
232.20 Titers
Interval 165.79 to 325.21
|
180.58 Titers
Interval 131.55 to 247.9
|
135.86 Titers
Interval 109.84 to 168.05
|
|
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Day 43
|
118.55 Titers
Interval 91.81 to 153.09
|
493.50 Titers
Interval 382.46 to 636.78
|
122.18 Titers
Interval 87.02 to 171.55
|
504.56 Titers
Interval 394.48 to 645.35
|
211.41 Titers
Interval 164.67 to 271.43
|
120.44 Titers
Interval 96.47 to 150.36
|
|
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Day 50
|
100.39 Titers
Interval 77.25 to 130.45
|
417.04 Titers
Interval 323.71 to 537.28
|
104.99 Titers
Interval 74.97 to 147.03
|
418.50 Titers
Interval 330.55 to 529.85
|
170.18 Titers
Interval 131.18 to 220.79
|
107.84 Titers
Interval 86.93 to 133.77
|
|
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Day 64
|
69.71 Titers
Interval 53.58 to 90.7
|
334.57 Titers
Interval 259.73 to 430.97
|
80.74 Titers
Interval 58.9 to 110.69
|
312.36 Titers
Interval 246.2 to 396.3
|
124.79 Titers
Interval 95.68 to 162.77
|
81.47 Titers
Interval 65.02 to 102.08
|
|
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Day 85
|
43.50 Titers
Interval 33.31 to 56.82
|
208.58 Titers
Interval 162.53 to 267.69
|
48.40 Titers
Interval 35.84 to 65.36
|
195.23 Titers
Interval 154.55 to 246.62
|
67.78 Titers
Interval 51.26 to 89.63
|
50.33 Titers
Interval 40.58 to 62.43
|
|
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Day 181
|
9.43 Titers
Interval 7.16 to 12.42
|
42.60 Titers
Interval 32.44 to 55.92
|
11.70 Titers
Interval 8.86 to 15.44
|
36.95 Titers
Interval 28.22 to 48.37
|
17.43 Titers
Interval 12.76 to 23.81
|
17.90 Titers
Interval 13.83 to 23.16
|
|
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
Day 394
|
4.76 Titers
Interval 4.51 to 5.02
|
12.52 Titers
Interval 9.09 to 17.23
|
7.09 Titers
Interval 5.74 to 8.76
|
9.24 Titers
Interval 7.3 to 11.7
|
6.74 Titers
Interval 5.14 to 8.83
|
10.33 Titers
Interval 8.17 to 13.06
|
SECONDARY outcome
Timeframe: Days 1, 8, 22, 29, 36, 43, 50, 85, 181, and 394Population: Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
The percentage of participants achieving seroprotection based on TNA NF50 antibody level. A 70% probability of survival was associated with a TNA NF50 level of 0.56 in rabbits exposed to Bacillus anthracis, the bacteria that causes anthrax.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=41 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=39 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=42 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=38 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
Day 181
|
0 Participants
|
11 Participants
|
4 Participants
|
13 Participants
|
2 Participants
|
5 Participants
|
|
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
Day 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
Day 22
|
0 Participants
|
18 Participants
|
14 Participants
|
4 Participants
|
2 Participants
|
24 Participants
|
|
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
Day 29
|
6 Participants
|
27 Participants
|
25 Participants
|
4 Participants
|
18 Participants
|
31 Participants
|
|
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
Day 36
|
15 Participants
|
35 Participants
|
28 Participants
|
38 Participants
|
33 Participants
|
31 Participants
|
|
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
Day 43
|
19 Participants
|
37 Participants
|
24 Participants
|
40 Participants
|
33 Participants
|
31 Participants
|
|
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
Day 50
|
14 Participants
|
38 Participants
|
25 Participants
|
40 Participants
|
30 Participants
|
30 Participants
|
|
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
Day 85
|
5 Participants
|
34 Participants
|
15 Participants
|
38 Participants
|
13 Participants
|
19 Participants
|
|
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
Day 394
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394Population: Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
The percentage of subjects obtaining seroconversion based on TNA NF50 antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=41 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=39 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=42 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=38 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 22
|
1 Participants
|
22 Participants
|
19 Participants
|
10 Participants
|
7 Participants
|
31 Participants
|
|
Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 29
|
9 Participants
|
30 Participants
|
34 Participants
|
9 Participants
|
30 Participants
|
37 Participants
|
|
Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 36
|
28 Participants
|
37 Participants
|
33 Participants
|
39 Participants
|
37 Participants
|
37 Participants
|
|
Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 43
|
38 Participants
|
38 Participants
|
32 Participants
|
41 Participants
|
40 Participants
|
37 Participants
|
|
Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 50
|
34 Participants
|
39 Participants
|
30 Participants
|
41 Participants
|
37 Participants
|
36 Participants
|
|
Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 64
|
27 Participants
|
39 Participants
|
27 Participants
|
41 Participants
|
35 Participants
|
35 Participants
|
|
Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 85
|
17 Participants
|
39 Participants
|
23 Participants
|
41 Participants
|
32 Participants
|
35 Participants
|
|
Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 181
|
4 Participants
|
26 Participants
|
12 Participants
|
27 Participants
|
8 Participants
|
19 Participants
|
|
Seroconversion Based on TNA NF50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 394
|
0 Participants
|
13 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394Population: Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
The percentage of subjects obtaining seroconversion based on TNA ED50 antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=41 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=39 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=42 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=38 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 22
|
1 Participants
|
22 Participants
|
20 Participants
|
11 Participants
|
6 Participants
|
32 Participants
|
|
Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 29
|
8 Participants
|
30 Participants
|
34 Participants
|
10 Participants
|
29 Participants
|
36 Participants
|
|
Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 36
|
29 Participants
|
37 Participants
|
34 Participants
|
40 Participants
|
38 Participants
|
37 Participants
|
|
Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 43
|
37 Participants
|
38 Participants
|
32 Participants
|
41 Participants
|
41 Participants
|
37 Participants
|
|
Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 50
|
34 Participants
|
39 Participants
|
31 Participants
|
41 Participants
|
37 Participants
|
36 Participants
|
|
Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 64
|
29 Participants
|
39 Participants
|
32 Participants
|
41 Participants
|
36 Participants
|
36 Participants
|
|
Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 85
|
15 Participants
|
38 Participants
|
22 Participants
|
40 Participants
|
31 Participants
|
32 Participants
|
|
Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 181
|
3 Participants
|
24 Participants
|
8 Participants
|
25 Participants
|
7 Participants
|
18 Participants
|
|
Seroconversion Based on TNA ED50, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 394
|
0 Participants
|
12 Participants
|
8 Participants
|
7 Participants
|
3 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394Population: Immunogenicity per protocol population (IPPP) includes all randomized participants who received a full dose of the correct vaccine at Days 1, 15, and 29 within the protocol specified windows, had determinate assay results at Day 64 (within window), and had no major protocol deviations that may have impacted immunogenicity assessments.
The percentage of subjects obtaining seroconversion based on ELISA anti-PA IgG antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Outcome measures
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=41 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=39 Participants
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=41 Participants
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=42 Participants
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=38 Participants
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 8
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 22
|
2 Participants
|
22 Participants
|
20 Participants
|
8 Participants
|
12 Participants
|
33 Participants
|
|
Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 29
|
16 Participants
|
31 Participants
|
38 Participants
|
9 Participants
|
36 Participants
|
37 Participants
|
|
Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 36
|
33 Participants
|
37 Participants
|
37 Participants
|
38 Participants
|
39 Participants
|
37 Participants
|
|
Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 43
|
39 Participants
|
38 Participants
|
36 Participants
|
41 Participants
|
41 Participants
|
36 Participants
|
|
Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 50
|
38 Participants
|
39 Participants
|
36 Participants
|
41 Participants
|
40 Participants
|
36 Participants
|
|
Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 64
|
31 Participants
|
39 Participants
|
34 Participants
|
41 Participants
|
38 Participants
|
36 Participants
|
|
Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 85
|
23 Participants
|
39 Participants
|
25 Participants
|
41 Participants
|
32 Participants
|
28 Participants
|
|
Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 181
|
4 Participants
|
23 Participants
|
4 Participants
|
24 Participants
|
10 Participants
|
7 Participants
|
|
Seroconversion Based on ELISA Anti-PA IgG, Defined as a ≥4-fold Increase Over Pre-vaccination Levels, or a ≥4-fold Increase Over the Lower Limit of Quantification (LLOQ) if the Pre-vaccination Value is Below the LLOQ
Day 394
|
0 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
Serious events: 1 serious events
Other events: 49 other events
Deaths: 0 deaths
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
Serious events: 0 serious events
Other events: 50 other events
Deaths: 0 deaths
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
Serious events: 2 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=50 participants at risk
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=50 participants at risk
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=49 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=52 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=52 participants at risk
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=52 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
2.0%
1/49 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
2.0%
1/49 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
2.0%
1/50 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
2.0%
1/50 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
2.0%
1/50 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
2.0%
1/50 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
2.0%
1/50 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
2.0%
1/49 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
3.8%
2/52 • Number of events 2 • From the first dose of study vaccine through Day 394.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
2.0%
1/49 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
Other adverse events
| Measure |
Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29)
n=50 participants at risk
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29)
n=50 participants at risk
Participants dosed intramuscularly (IM) on Days 1, 15, and 29 with 0.5 mL AV7909
|
Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=49 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5mL placebo
|
Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15)
n=52 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 29 with 0.5 mL AV7909 and dosed IM on Day 15 with 0.5 mL placebo
|
Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29)
n=52 participants at risk
Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax
|
Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29)
n=52 participants at risk
Participants dosed intramuscularly (IM) on Days 1 and 15 with 0.5 mL AV7909 and dosed IM on Day 29 with 0.5 mL placebo
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site mass
|
76.0%
38/50 • Number of events 93 • From the first dose of study vaccine through Day 394.
|
20.0%
10/50 • Number of events 12 • From the first dose of study vaccine through Day 394.
|
10.2%
5/49 • Number of events 5 • From the first dose of study vaccine through Day 394.
|
23.1%
12/52 • Number of events 16 • From the first dose of study vaccine through Day 394.
|
71.2%
37/52 • Number of events 75 • From the first dose of study vaccine through Day 394.
|
15.4%
8/52 • Number of events 9 • From the first dose of study vaccine through Day 394.
|
|
General disorders
Injection site movement impairment
|
14.0%
7/50 • Number of events 10 • From the first dose of study vaccine through Day 394.
|
44.0%
22/50 • Number of events 31 • From the first dose of study vaccine through Day 394.
|
20.4%
10/49 • Number of events 17 • From the first dose of study vaccine through Day 394.
|
19.2%
10/52 • Number of events 13 • From the first dose of study vaccine through Day 394.
|
28.8%
15/52 • Number of events 30 • From the first dose of study vaccine through Day 394.
|
46.2%
24/52 • Number of events 32 • From the first dose of study vaccine through Day 394.
|
|
General disorders
Injection site pain
|
88.0%
44/50 • Number of events 152 • From the first dose of study vaccine through Day 394.
|
82.0%
41/50 • Number of events 126 • From the first dose of study vaccine through Day 394.
|
73.5%
36/49 • Number of events 77 • From the first dose of study vaccine through Day 394.
|
82.7%
43/52 • Number of events 91 • From the first dose of study vaccine through Day 394.
|
94.2%
49/52 • Number of events 191 • From the first dose of study vaccine through Day 394.
|
96.2%
50/52 • Number of events 138 • From the first dose of study vaccine through Day 394.
|
|
General disorders
Injection site pruritus
|
52.0%
26/50 • Number of events 48 • From the first dose of study vaccine through Day 394.
|
14.0%
7/50 • Number of events 9 • From the first dose of study vaccine through Day 394.
|
6.1%
3/49 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
7.7%
4/52 • Number of events 6 • From the first dose of study vaccine through Day 394.
|
57.7%
30/52 • Number of events 60 • From the first dose of study vaccine through Day 394.
|
9.6%
5/52 • Number of events 7 • From the first dose of study vaccine through Day 394.
|
|
General disorders
Injection site warmth
|
52.0%
26/50 • Number of events 65 • From the first dose of study vaccine through Day 394.
|
42.0%
21/50 • Number of events 31 • From the first dose of study vaccine through Day 394.
|
22.4%
11/49 • Number of events 13 • From the first dose of study vaccine through Day 394.
|
28.8%
15/52 • Number of events 25 • From the first dose of study vaccine through Day 394.
|
51.9%
27/52 • Number of events 60 • From the first dose of study vaccine through Day 394.
|
25.0%
13/52 • Number of events 19 • From the first dose of study vaccine through Day 394.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
6.0%
3/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
2.0%
1/49 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
7.7%
4/52 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
|
General disorders
Chills
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
4.0%
2/50 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
4.1%
2/49 • Number of events 2 • From the first dose of study vaccine through Day 394.
|
5.8%
3/52 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
3.8%
2/52 • Number of events 2 • From the first dose of study vaccine through Day 394.
|
|
General disorders
Fatigue
|
18.0%
9/50 • Number of events 12 • From the first dose of study vaccine through Day 394.
|
34.0%
17/50 • Number of events 25 • From the first dose of study vaccine through Day 394.
|
28.6%
14/49 • Number of events 17 • From the first dose of study vaccine through Day 394.
|
26.9%
14/52 • Number of events 21 • From the first dose of study vaccine through Day 394.
|
19.2%
10/52 • Number of events 14 • From the first dose of study vaccine through Day 394.
|
40.4%
21/52 • Number of events 28 • From the first dose of study vaccine through Day 394.
|
|
General disorders
Injection site bruising
|
24.0%
12/50 • Number of events 14 • From the first dose of study vaccine through Day 394.
|
8.0%
4/50 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
14.3%
7/49 • Number of events 8 • From the first dose of study vaccine through Day 394.
|
5.8%
3/52 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
17.3%
9/52 • Number of events 10 • From the first dose of study vaccine through Day 394.
|
13.5%
7/52 • Number of events 7 • From the first dose of study vaccine through Day 394.
|
|
General disorders
Injection site discolouration
|
8.0%
4/50 • Number of events 5 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
General disorders
Injection site erythema
|
68.0%
34/50 • Number of events 74 • From the first dose of study vaccine through Day 394.
|
26.0%
13/50 • Number of events 18 • From the first dose of study vaccine through Day 394.
|
14.3%
7/49 • Number of events 8 • From the first dose of study vaccine through Day 394.
|
13.5%
7/52 • Number of events 8 • From the first dose of study vaccine through Day 394.
|
51.9%
27/52 • Number of events 55 • From the first dose of study vaccine through Day 394.
|
9.6%
5/52 • Number of events 5 • From the first dose of study vaccine through Day 394.
|
|
General disorders
Injection site induration
|
68.0%
34/50 • Number of events 74 • From the first dose of study vaccine through Day 394.
|
30.0%
15/50 • Number of events 22 • From the first dose of study vaccine through Day 394.
|
14.3%
7/49 • Number of events 7 • From the first dose of study vaccine through Day 394.
|
21.2%
11/52 • Number of events 14 • From the first dose of study vaccine through Day 394.
|
55.8%
29/52 • Number of events 57 • From the first dose of study vaccine through Day 394.
|
23.1%
12/52 • Number of events 14 • From the first dose of study vaccine through Day 394.
|
|
General disorders
Pyrexia
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
6.0%
3/50 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
10.2%
5/49 • Number of events 5 • From the first dose of study vaccine through Day 394.
|
9.6%
5/52 • Number of events 6 • From the first dose of study vaccine through Day 394.
|
5.8%
3/52 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
13.5%
7/52 • Number of events 8 • From the first dose of study vaccine through Day 394.
|
|
Infections and infestations
Bronchitis
|
6.0%
3/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
2.0%
1/50 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
2.0%
1/49 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
3.8%
2/52 • Number of events 2 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
3/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
4.0%
2/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
14.3%
7/49 • Number of events 8 • From the first dose of study vaccine through Day 394.
|
9.6%
5/52 • Number of events 5 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 2 • From the first dose of study vaccine through Day 394.
|
5.8%
3/52 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/50 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
6.0%
3/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 2 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
6.0%
3/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
2.0%
1/49 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
5.8%
3/52 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
6.0%
3/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
4.1%
2/49 • Number of events 2 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
6.0%
3/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
4/50 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
6.0%
3/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
6.1%
3/49 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
5.8%
3/52 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.0%
2/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
6.0%
3/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
4.1%
2/49 • Number of events 2 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
2/50 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
22.0%
11/50 • Number of events 19 • From the first dose of study vaccine through Day 394.
|
16.3%
8/49 • Number of events 9 • From the first dose of study vaccine through Day 394.
|
25.0%
13/52 • Number of events 20 • From the first dose of study vaccine through Day 394.
|
15.4%
8/52 • Number of events 12 • From the first dose of study vaccine through Day 394.
|
50.0%
26/52 • Number of events 37 • From the first dose of study vaccine through Day 394.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/50 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
6.0%
3/50 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
2.0%
1/49 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.0%
2/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
8.0%
4/50 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
4/50 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
6.0%
3/50 • Number of events 3 • From the first dose of study vaccine through Day 394.
|
0.00%
0/49 • From the first dose of study vaccine through Day 394.
|
3.8%
2/52 • Number of events 2 • From the first dose of study vaccine through Day 394.
|
0.00%
0/52 • From the first dose of study vaccine through Day 394.
|
3.8%
2/52 • Number of events 2 • From the first dose of study vaccine through Day 394.
|
|
Nervous system disorders
Headache
|
22.0%
11/50 • Number of events 17 • From the first dose of study vaccine through Day 394.
|
36.0%
18/50 • Number of events 41 • From the first dose of study vaccine through Day 394.
|
12.2%
6/49 • Number of events 16 • From the first dose of study vaccine through Day 394.
|
32.7%
17/52 • Number of events 26 • From the first dose of study vaccine through Day 394.
|
23.1%
12/52 • Number of events 17 • From the first dose of study vaccine through Day 394.
|
50.0%
26/52 • Number of events 37 • From the first dose of study vaccine through Day 394.
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • From the first dose of study vaccine through Day 394.
|
2.0%
1/50 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
8.2%
4/49 • Number of events 4 • From the first dose of study vaccine through Day 394.
|
3.8%
2/52 • Number of events 2 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
1.9%
1/52 • Number of events 1 • From the first dose of study vaccine through Day 394.
|
Additional Information
Susan Hollingsworth/Regulatory Operations Specialist
BARDA
Phone: 202-691-2040
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Data and results are owned by Sponsor. Results can be used by Institution for (a) internal non-commercial research, education and patient care, and (b) as required under applicable laws and regulations. Other uses require prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER