NCT01770743Phase 2Completed

A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2014-02Actual

Enrollment · participants168Actual

Source updated2024-03-18Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Anthrax

Treatments or interventions studied

AV7909BiologicalAlso known as AV7909 Anthrax Vaccine, NuThrax
BioThraxBiologicalAlso known as Anthrax Vaccine Adsorbed (AVA)

Primary outcomes · main study measures

Read the study measures

measure: Toxin Neutralizing Antibody (TNA) Level at Day 63; description: Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold; timeFrame: Day 63; measure: Incidence of Adverse Events; description: Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84; timeFrame: From the time of the first immunization on Day 0 through Day 84; measure: Incidence of Serious Adverse Events; description: Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination; timeFrame: From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination; measure: Incidence of Reactogenicity By Severity; description: Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity. Reactions were graded using the following scale (note, for redness and swelling, the diameter \[greater of two perpendicular measurements\] was assessed by the subject using an injection site measurement tool): Grade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures \<3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 - 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures \> 10 cm. For each reaction, subjects are counted once across all vaccinations at the highest reported level of severity.; timeFrame: For 7 days following each vaccination on Days 0, 14, 28; measure: Incidence of Clinical Laborabory Abnormalities; description: Incidence of clinical laboratory abnormalities throughout the study (up to Day 84). Clinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality.; timeFrame: From the time of first immunization on Day 0 to Day 84; measure: Incidence of Immunologically Significant Adverse Events of Special Interest; description: Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination; timeFrame: From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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