Anthrax
Conditions
Keywords
Anthrax, Bacillaceae Infections, Gram-Positive Bacterial Infections, Bacterial Infections, Anthrax Vaccine Adsorbed, BioThrax, AV7909, CPG 7909, Adjuvant, Vaccines, Post-exposure Prophylaxis
Brief summary
This study is designed to assess the safety and ability of BioThrax and AV7909 anthrax vaccines to generate an immune response in adults ≥ 66 years of age in stable health in comparison to adults 18-50 years of age in stable health.
Detailed description
This is a phase 2, randomized, active-controlled, double-blinded, multi-site study to assess the safety and immunogenicity of BioThrax (Anthrax Vaccine Adsorbed) and AV7909 (Anthrax Vaccine Adsorbed plus CPG 7909 adjuvant) using a post-exposure prophylaxis dosing regimen in adults ≥ 66 years of age in stable health. The safety and immunogenicity profile of BioThrax and AV7909 in adults ≥ 66 years of age will also be compared to the safety and immunogenicity profile of subjects 18-50 years of age in stable health. The main study goal is to determine optimal dosing for AV7909 in the elderly population. Subjects will receive either 3 doses of BioThrax, 3 doses of AV7909, or 2 doses of AV7909 and 1 dose of placebo. Doses will be administered approximately 14 days apart. Subjects will be followed for safety assessment for 12 months following the last dose. The expected study duration is approximately 14 months per subject.
Interventions
Sponsors
Rho, Inc.
Biomedical Advanced Research and Development Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Subjects will be randomized to receive either BioThrax or AV7909. Randomization will be stratified by sex and age (18-50, 66-74, and ≥75 years). Subjects ≥66 years of age will be randomized 1:1:1:1 within stratum across 4 treatment arms (approximately 50 subjects per group), and subjects 18 through 50 years of age will be randomized 1:1 within stratum across 2 treatment arms (approximately 50 subjects per group). Once randomized, subjects will receive 3 vaccinations, each separated by approximately 14 days, on Day 1, Day 15, and Day 29, based on their assigned treatment arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or nonpregnant females, 66 years of age or older at the time of randomization for the elderly population, or 18 through 50 years of age at the time of randomization for the younger population. 2. Females who are of childbearing potential and are sexually active with a male partner must agree to use an acceptable method of birth control from Screening to Day 64 and must have used a reliable birth control method for at least 2 months prior to Screening. 1. A female of childbearing potential is defined as post onset menarche and pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: menopausal \>2 years, tubal ligation \>1 year, bilateral salpingo-oophorectomy, or hysterectomy. 2. Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label. Examples include: oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etenogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; male partner sterilization at least 6 months prior to the female subject's Screening Visit, and this male is the sole partner for that subject (the information on the male partner's sterility can come from the site personnel's review of the subject's medical records or interview with the subject on her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository). 3. Able to provide written informed consent prior to initiation of any study procedures. As part of the consent process, subjects must be able to demonstrate understanding by passing the Assessment of Understanding Questionnaire within 2 attempts. Passing is defined as being able to answer all questions correctly. 4. In relatively stable health based on site investigator's judgment, as determined by medical history, physical examination, and the following criteria: 1. Stable health for age (defined as no new conditions per medical history, new medications in a different therapeutic class, or change in daily dose of existing prescription medications within the 45 days preceding Screening). Effective treatment (to resolution) of an acute infection (e.g., urinary tract infection, cellulitis, otitis, or bronchitis) with an antibiotic within 45 days preceding Screening will not be considered a deviation from this inclusion criterion as long as the antibiotic therapy was completed at least one week prior to Screening and no signs or symptoms of the infection have been present since the completion of treatment. Any prescription change that is due to change of health care provider or insurance company, or that is made for reasons that do not reflect a change in disease status (e.g., financial considerations), as long as within the same general class of medication, will not be considered a deviation from this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site investigator, will not be considered a deviation from this inclusion criterion. 2. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site investigator, these pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and their use is not for management of a worsening of medical diagnosis or condition. Note: Topical, nasal, and inhaled medications (with the exception of steroids, as outlined in the subject
Exclusion criteria
) and vitamins are permitted. 5. Have a body mass index (BMI) less than 35.0 kg/m2 at Screening. (BMI will not be reassessed prior to subsequent vaccinations.) 6. Have access to a consistent and reliable means of telephone contact, which may be home, workplace, or by personal mobile electronic device. 7. Are available and able to comply with all study visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solicited Local Reactogenicity Symptoms | Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day) | 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. |
| Solicited Systemic Reactogenicity Symptoms | Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day) | 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. |
| Seroprotection Based on Toxin Neutralization Antibody (TNA) 50% Neutralization Factor (NF50) Antibody Level, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 64 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) | Day 1 through Day 394 | Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination |
| Solicited Local Reactogenicity Symptoms on the Contralateral Arm | Day 1-8, Day 15-22, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day) | 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. |
| TNA NF50 Antibody Levels | Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394 | A higher TNA NF50 antibody level means a better immune response to the vaccine. |
| TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394 | A higher TNA ED50 antibody level means a better immune response to the vaccine. |
| Treatment-emergent Unsolicited Adverse Events (AEs) | Day 1 through Day 394 | 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). |
| Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Days 1, 8, 22, 29, 36, 43, 50, 85, 181, and 394 | 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. |
| 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 | Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394 | The percentage of subjects obtaining seroconversion based on TNA NF50 antibody levels. Seroconversion represents the minimum intended effect of vaccination. |
| 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 | Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394 | The percentage of subjects obtaining seroconversion based on TNA ED50 antibody levels. Seroconversion represents the minimum intended effect of vaccination. |
| 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 | Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394 | The percentage of subjects obtaining seroconversion based on ELISA anti-PA IgG antibody levels. Seroconversion represents the minimum intended effect of vaccination. |
| Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394 | A higher ELISA anti-PA IgG antibody level means a better immune response to the vaccine. |
| Treatment-emergent Serious Adverse Events (SAEs) | Day 1 through Day 394 | The count of participants who experienced at least one post-vaccination SAE |
| Treatment-emergent Medically Attended Adverse Events (MAAEs) | Day 1 through Day 394 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) Participants dosed subcutaneously (SC) on Days 1, 15, and 29 with 0.5 mL BioThrax | 50 |
| 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 | 50 |
| Age ≥ 66 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 | 49 |
| 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 | 52 |
| 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 | 52 |
| 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 | 52 |
| Total | 305 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 0 | 3 | 5 |
| Overall Study | Missed Day 394 Visit | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Age, Categorical >=65 years | 50 Participants | 49 Participants | 52 Participants | 0 Participants | 0 Participants | 50 Participants | 201 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 51 Participants | 51 Participants | 0 Participants | 102 Participants |
| Age, Continuous | 71.2 years STANDARD_DEVIATION 4.76 | 72.8 years STANDARD_DEVIATION 4.88 | 72.5 years STANDARD_DEVIATION 5.04 | 33.5 years STANDARD_DEVIATION 9.46 | 33.7 years STANDARD_DEVIATION 9.55 | 72.7 years STANDARD_DEVIATION 5.89 | 59.1 years STANDARD_DEVIATION 19.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 48 Participants | 50 Participants | 51 Participants | 48 Participants | 49 Participants | 294 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 2 Participants | 6 Participants | 3 Participants | 4 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 46 Participants | 46 Participants | 47 Participants | 45 Participants | 47 Participants | 46 Participants | 277 Participants |
| Region of Enrollment United States | 50 participants | 49 participants | 52 participants | 52 participants | 52 participants | 50 participants | 305 participants |
| Sex/Gender, Customized Gender Female | 29 Participants | 27 Participants | 31 Participants | 29 Participants | 29 Participants | 28 Participants | 173 Participants |
| Sex/Gender, Customized Gender Male | 21 Participants | 22 Participants | 21 Participants | 23 Participants | 23 Participants | 22 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 49 | 0 / 52 | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 49 / 50 | 46 / 50 | 44 / 49 | 50 / 52 | 50 / 52 | 51 / 52 |
| serious Total, serious adverse events | 1 / 50 | 3 / 50 | 3 / 49 | 2 / 52 | 0 / 52 | 2 / 52 |
Outcome results
Primary
Seroprotection Based on Toxin Neutralization Antibody (TNA) 50% Neutralization Factor (NF50) Antibody Level, Defined as a TNA NF50 Antibody Level ≥0.56
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.
Time frame: Day 64
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Seroprotection Based on Toxin Neutralization Antibody (TNA) 50% Neutralization Factor (NF50) Antibody Level, Defined as a TNA NF50 Antibody Level ≥0.56 | 7 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Seroprotection Based on Toxin Neutralization Antibody (TNA) 50% Neutralization Factor (NF50) Antibody Level, Defined as a TNA NF50 Antibody Level ≥0.56 | 37 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on Toxin Neutralization Antibody (TNA) 50% Neutralization Factor (NF50) Antibody Level, Defined as a TNA NF50 Antibody Level ≥0.56 | 19 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Seroprotection Based on Toxin Neutralization Antibody (TNA) 50% Neutralization Factor (NF50) Antibody Level, Defined as a TNA NF50 Antibody Level ≥0.56 | 40 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Seroprotection Based on Toxin Neutralization Antibody (TNA) 50% Neutralization Factor (NF50) Antibody Level, Defined as a TNA NF50 Antibody Level ≥0.56 | 22 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on Toxin Neutralization Antibody (TNA) 50% Neutralization Factor (NF50) Antibody Level, Defined as a TNA NF50 Antibody Level ≥0.56 | 23 Participants |
Primary
Solicited Local Reactogenicity Symptoms
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Solicited Local Reactogenicity Symptoms | 46 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Solicited Local Reactogenicity Symptoms | 43 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Solicited Local Reactogenicity Symptoms | 40 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Solicited Local Reactogenicity Symptoms | 45 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Solicited Local Reactogenicity Symptoms | 50 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Solicited Local Reactogenicity Symptoms | 50 Participants |
Primary
Solicited Systemic Reactogenicity Symptoms
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Solicited Systemic Reactogenicity Symptoms | 14 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Solicited Systemic Reactogenicity Symptoms | 23 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Solicited Systemic Reactogenicity Symptoms | 18 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Solicited Systemic Reactogenicity Symptoms | 20 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Solicited Systemic Reactogenicity Symptoms | 15 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Solicited Systemic Reactogenicity Symptoms | 35 Participants |
Secondary
Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels
A higher ELISA anti-PA IgG antibody level means a better immune response to the vaccine.
Time frame: Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 50 | 100.39 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 36 | 75.98 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 394 | 4.76 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 85 | 43.50 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 43 | 118.55 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 8 | 4.64 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 1 | 4.64 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 22 | 6.06 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 29 | 29.84 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 64 | 69.71 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 181 | 9.43 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 181 | 42.60 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 50 | 417.04 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 29 | 124.04 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 36 | 347.86 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 22 | 37.28 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 394 | 12.52 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 85 | 208.58 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 64 | 334.57 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 1 | 4.78 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 43 | 493.50 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 8 | 4.77 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 43 | 122.18 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 64 | 80.74 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 50 | 104.99 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 8 | 4.64 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 1 | 4.64 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 22 | 40.33 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 181 | 11.70 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 29 | 138.17 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 394 | 7.09 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 85 | 48.40 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 36 | 134.15 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 181 | 36.95 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 1 | 4.91 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 8 | 4.96 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 22 | 10.26 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 29 | 11.98 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 36 | 232.20 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 43 | 504.56 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 50 | 418.50 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 64 | 312.36 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 85 | 195.23 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 394 | 9.24 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 64 | 124.79 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 22 | 19.61 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 394 | 6.74 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 181 | 17.43 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 85 | 67.78 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 8 | 4.78 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 36 | 180.58 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 1 | 4.64 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 29 | 106.64 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 50 | 170.18 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 43 | 211.41 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 43 | 120.44 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 394 | 10.33 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 64 | 81.47 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 36 | 135.86 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 29 | 139.82 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 85 | 50.33 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 22 | 80.66 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 8 | 4.64 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 181 | 17.90 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 1 | 4.64 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Enzyme-linked Immunosorbent Assay (ELISA) Anti-protective Antigen (Anti-PA) Immunoglobulin G (IgG) Antibody Levels | Day 50 | 107.84 Titers |
Secondary
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
The percentage of subjects obtaining seroconversion based on ELISA anti-PA IgG antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 39 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 31 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 37 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 23 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 4 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 39 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 39 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 38 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 22 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 37 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 25 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 36 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 36 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 20 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 34 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 38 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 41 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 41 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 24 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 3 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 8 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 9 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 38 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 41 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 41 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 1 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 10 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 40 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 38 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 41 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 32 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 12 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 36 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 39 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 33 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 37 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 36 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 7 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 36 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 28 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 37 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 36 Participants |
Secondary
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
The percentage of subjects obtaining seroconversion based on TNA ED50 antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 30 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 22 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 37 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 38 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 39 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 39 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 38 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 24 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 12 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 20 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 32 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 31 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 22 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 34 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 8 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 8 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 32 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 34 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 41 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 11 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 7 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 40 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 41 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 40 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 41 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 25 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 10 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 6 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 38 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 41 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 37 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 36 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 31 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 3 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 7 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 29 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 36 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 36 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 32 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 13 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 37 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 32 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 36 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 18 Participants |
Secondary
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
The percentage of subjects obtaining seroconversion based on TNA NF50 antibody levels. Seroconversion represents the minimum intended effect of vaccination.
Time frame: Days 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 22 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 30 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 37 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 39 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 39 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 39 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 26 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | 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 | 13 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 33 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 23 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 32 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 34 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 19 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 30 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 12 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 7 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 41 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 41 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 10 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 7 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 27 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 41 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 41 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 | 39 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | 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 |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 35 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 37 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 40 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 37 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 32 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 3 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 8 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 30 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | 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 | 7 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 36 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 17 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 31 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 37 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 37 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 35 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 37 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 35 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | 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 | 19 Participants |
Secondary
Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56
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.
Time frame: Days 1, 8, 22, 29, 36, 43, 50, 85, 181, and 394
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 22 | 0 Participants |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 50 | 14 Participants |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 85 | 5 Participants |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 43 | 19 Participants |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 8 | 0 Participants |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 29 | 6 Participants |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 1 | 0 Participants |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 394 | 0 Participants |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 36 | 15 Participants |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 181 | 0 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 394 | 3 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 43 | 37 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 36 | 35 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 181 | 11 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 85 | 34 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 8 | 0 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 50 | 38 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 22 | 18 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 1 | 0 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 29 | 27 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 1 | 0 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 43 | 24 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 22 | 14 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 181 | 4 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 29 | 25 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 394 | 2 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 8 | 0 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 36 | 28 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 85 | 15 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 50 | 25 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 85 | 38 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 394 | 1 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 1 | 0 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 8 | 0 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 22 | 4 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 29 | 4 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 36 | 38 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 43 | 40 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 50 | 40 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 181 | 13 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 85 | 13 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 1 | 0 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 43 | 33 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 181 | 2 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 50 | 30 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 394 | 1 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 22 | 2 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 36 | 33 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 8 | 0 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 29 | 18 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 29 | 31 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 22 | 24 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 181 | 5 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 8 | 0 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 50 | 30 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 1 | 0 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 85 | 19 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 394 | 2 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 43 | 31 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Seroprotection Based on TNA NF50, Defined as a TNA NF50 Antibody Level ≥0.56 | Day 36 | 31 Participants |
Secondary
Solicited Local Reactogenicity Symptoms on the Contralateral Arm
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Solicited Local Reactogenicity Symptoms on the Contralateral Arm | 11 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Solicited Local Reactogenicity Symptoms on the Contralateral Arm | 6 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Solicited Local Reactogenicity Symptoms on the Contralateral Arm | 3 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Solicited Local Reactogenicity Symptoms on the Contralateral Arm | 5 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Solicited Local Reactogenicity Symptoms on the Contralateral Arm | 7 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Solicited Local Reactogenicity Symptoms on the Contralateral Arm | 2 Participants |
Secondary
TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels
A higher TNA ED50 antibody level means a better immune response to the vaccine.
Time frame: Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 50 | 250.88 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 36 | 187.97 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 394 | 18.29 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 85 | 85.20 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 43 | 299.59 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 8 | 16.5 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 1 | 16.5 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 22 | 20.13 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 29 | 54.88 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 64 | 184.31 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 181 | 25.55 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 181 | 163.46 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 50 | 1658.94 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 29 | 410.47 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 36 | 1557.95 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 22 | 136.20 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 394 | 74.48 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 85 | 650.14 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 64 | 1240.66 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 1 | 16.5 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 43 | 2135.14 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 8 | 16.5 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 43 | 361.30 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 64 | 248.04 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 50 | 315.10 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 8 | 16.5 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 1 | 16.5 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 22 | 122.26 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 181 | 55.87 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 29 | 411.94 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 394 | 49.63 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 85 | 136.72 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 36 | 389.79 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 181 | 151.24 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 1 | 16.5 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 8 | 16.5 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 22 | 52.24 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 29 | 63.02 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 36 | 1548.57 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 43 | 3490.12 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 50 | 2600.22 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 64 | 1771.46 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 85 | 902.39 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 394 | 50.29 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 64 | 321.15 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 22 | 35.66 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 394 | 27.46 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 181 | 55.17 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 85 | 181.14 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 8 | 17.18 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 36 | 410.11 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 1 | 16.5 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 29 | 208.90 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 50 | 414.59 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 43 | 495.07 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 43 | 497.77 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 394 | 76.66 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 64 | 363.05 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 36 | 519.81 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 29 | 501.88 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 85 | 224.09 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 22 | 322.78 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 8 | 16.5 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 181 | 108.67 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 1 | 16.5 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA Effective Dilution Resulting in 50% Neutralization (ED50) Antibody Levels | Day 50 | 435.56 Titers |
Secondary
TNA NF50 Antibody Levels
A higher TNA NF50 antibody level means a better immune response to the vaccine.
Time frame: Days 1, 8, 22, 29, 36, 43, 50, 64, 85, 181, and 394
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 50 | .45 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 36 | .36 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 394 | .04 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 85 | .20 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 43 | .55 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 8 | .03 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 1 | .03 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 22 | .04 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 29 | .11 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 64 | .32 Titers |
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 181 | .05 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 181 | .37 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 50 | 3.38 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 29 | .77 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 36 | 2.92 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 22 | .25 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 394 | .14 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 85 | 1.48 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 64 | 2.36 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 1 | .03 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 43 | 4.26 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 8 | .03 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 43 | .69 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 64 | .44 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 50 | .60 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 8 | .03 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 1 | .03 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 22 | .23 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 181 | .12 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 29 | .80 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 394 | .10 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 85 | .30 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 36 | .75 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA NF50 Antibody Levels | Day 181 | .34 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA NF50 Antibody Levels | Day 1 | .03 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA NF50 Antibody Levels | Day 8 | .03 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA NF50 Antibody Levels | Day 22 | .10 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA NF50 Antibody Levels | Day 29 | .12 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA NF50 Antibody Levels | Day 36 | 2.98 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA NF50 Antibody Levels | Day 43 | 6.73 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA NF50 Antibody Levels | Day 50 | 5.30 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA NF50 Antibody Levels | Day 64 | 3.42 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA NF50 Antibody Levels | Day 85 | 2.08 Titers |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | TNA NF50 Antibody Levels | Day 394 | .09 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 64 | .59 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 22 | .08 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 394 | .05 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 181 | .12 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 85 | .42 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 8 | .03 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 36 | .84 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 1 | .03 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 29 | .43 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 50 | .79 Titers |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | TNA NF50 Antibody Levels | Day 43 | .94 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 43 | .94 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 394 | .16 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 64 | .69 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 36 | 1.06 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 29 | 1.02 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 85 | .53 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 22 | .67 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 8 | .03 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 181 | .23 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 1 | .03 Titers |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | TNA NF50 Antibody Levels | Day 50 | .84 Titers |
Secondary
Treatment-emergent Medically Attended Adverse Events (MAAEs)
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.
Time frame: Day 1 through Day 394
Population: Safety population includes all randomized participants who received any amount of study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Treatment-emergent Medically Attended Adverse Events (MAAEs) | 27 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Treatment-emergent Medically Attended Adverse Events (MAAEs) | 23 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Treatment-emergent Medically Attended Adverse Events (MAAEs) | 21 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Treatment-emergent Medically Attended Adverse Events (MAAEs) | 23 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Treatment-emergent Medically Attended Adverse Events (MAAEs) | 13 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Treatment-emergent Medically Attended Adverse Events (MAAEs) | 14 Participants |
Secondary
Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs)
Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination
Time frame: Day 1 through Day 394
Population: Safety population includes all randomized participants who received any amount of study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) | 0 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) | 0 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) | 1 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) | 0 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) | 0 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) | 0 Participants |
Secondary
Treatment-emergent Serious Adverse Events (SAEs)
The count of participants who experienced at least one post-vaccination SAE
Time frame: Day 1 through Day 394
Population: Safety population includes all randomized participants who received any amount of study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Treatment-emergent Serious Adverse Events (SAEs) | 1 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Treatment-emergent Serious Adverse Events (SAEs) | 3 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Treatment-emergent Serious Adverse Events (SAEs) | 3 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Treatment-emergent Serious Adverse Events (SAEs) | 2 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Treatment-emergent Serious Adverse Events (SAEs) | 0 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Treatment-emergent Serious Adverse Events (SAEs) | 2 Participants |
Secondary
Treatment-emergent Unsolicited Adverse Events (AEs)
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).
Time frame: Day 1 through Day 394
Population: Safety population includes all randomized participants who received any amount of study vaccination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Age ≥ 66 Years: BioThrax (Day1, Day 15, Day 29) | Treatment-emergent Unsolicited Adverse Events (AEs) | 41 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15, Day 29) | Treatment-emergent Unsolicited Adverse Events (AEs) | 34 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Treatment-emergent Unsolicited Adverse Events (AEs) | 32 Participants |
| Age ≥ 66 Years: AV7909 (Day 1, Day 29) With Placebo (Day 15) | Treatment-emergent Unsolicited Adverse Events (AEs) | 39 Participants |
| Age 18-50 Years: BioThrax (Day 1, Day 15, Day 29) | Treatment-emergent Unsolicited Adverse Events (AEs) | 30 Participants |
| Age 18-50 Years: AV7909 (Day 1, Day 15) With Placebo (Day 29) | Treatment-emergent Unsolicited Adverse Events (AEs) | 26 Participants |