Trial Outcomes & Findings for Ciprofloxacin BioThrax Co-Administration Study (NCT NCT01753115)
NCT ID: NCT01753115
Last Updated: 2025-06-15
Results Overview
Ratios of Area Under the Curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin (Day 5/Day 44).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
Day 5 and Day 44 in Arm 1
Results posted on
2025-06-15
Participant Flow
Subjects were enrolled from 14 Dec 2012 to 04 Aug 2013 at 3 US sites.
Participant milestones
| Measure |
BioThrax + Ciprofloxacin PK
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day
|
BioThrax + Ciprofloxacin no PK
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day
|
BioThrax Only
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
40
|
70
|
|
Overall Study
Treated
|
38
|
39
|
67
|
|
Overall Study
COMPLETED
|
32
|
25
|
56
|
|
Overall Study
NOT COMPLETED
|
12
|
15
|
14
|
Reasons for withdrawal
| Measure |
BioThrax + Ciprofloxacin PK
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day
|
BioThrax + Ciprofloxacin no PK
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day
|
BioThrax Only
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
8
|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
6
|
|
Overall Study
Subject non-compliant
|
3
|
3
|
0
|
|
Overall Study
Used excluded drug
|
0
|
1
|
0
|
Baseline Characteristics
Ciprofloxacin BioThrax Co-Administration Study
Baseline characteristics by cohort
| Measure |
BioThrax + Ciprofloxacin PK
n=44 Participants
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day
|
BioThrax + Ciprofloxacin no PK
n=40 Participants
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day
|
BioThrax Only
n=70 Participants
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 8.76 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 8.05 • n=7 Participants
|
30.2 years
STANDARD_DEVIATION 7.29 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 7.88 • n=4 Participants
|
|
Age, Customized
18 - 30 years
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
35 participants
n=5 Participants
|
77 participants
n=4 Participants
|
|
Age, Customized
31 - 45 years
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
35 participants
n=5 Participants
|
77 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
24 participants
n=5 Participants
|
22 participants
n=7 Participants
|
33 participants
n=5 Participants
|
79 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African America
|
20 participants
n=5 Participants
|
14 participants
n=7 Participants
|
34 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 5 and Day 44 in Arm 1Population: Per protocol population: all subjects in arm 1 who received any dose of ciprofloxacin, had adequate PK data on Day 5 and Day 44, had received all three BioThrax doses, and who had no key protocol deviations (e.g., insufficient blood sample) that would be expected to affect the ciprofloxacin PK assessment.
Ratios of Area Under the Curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin (Day 5/Day 44).
Outcome measures
| Measure |
Arm 1 = BioThrax (0.5 mL) + Ciprofloxacin (500 mg Bid) + PK
n=32 Participants
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day
|
BioThrax Only (Arm 3)
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
|
|---|---|---|
|
Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)
Ratio Cmax Day 44/Day 5
|
0.944 ratio
Interval 0.852 to 1.046
|
—
|
|
Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)
Ratio AUC0-12hr Day 44/Day 5
|
0.887 ratio
Interval 0.831 to 0.948
|
—
|
SECONDARY outcome
Timeframe: Two weeks after last vaccinationPopulation: BioThrax immunogenicity population: received 3 vaccinations and had samples taken within the study-specified windows; had a valid immunogenicity result within 2 wks of the last vaccination; had no evidence of previous anthrax vaccination and received the correct BioThrax dose at all 3 times; received vaccine maintained at the proper temperature.
Blood was collected in arms 1 and 2 at day 48 ( 2 weeks following last vaccination) and in arm 3 at day 43 ( 2 weeks following last vaccination) for TNA assay to determine the NF50 antibody titer for calculating GMT.
Outcome measures
| Measure |
Arm 1 = BioThrax (0.5 mL) + Ciprofloxacin (500 mg Bid) + PK
n=50 Participants
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day
|
BioThrax Only (Arm 3)
n=50 Participants
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
|
|---|---|---|
|
Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels
|
1.170 titer
Interval 0.912 to 1.5
|
0.923 titer
Interval 0.723 to 1.78
|
Adverse Events
BioThrax + Ciprofloxacin PK
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BioThrax + Ciprofloxacin no PK
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BioThrax Only
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BioThrax + Ciprofloxacin PK
n=38 participants at risk
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day
|
BioThrax + Ciprofloxacin no PK
n=39 participants at risk
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Ciprofloxacin: 500 mg twice a day
|
BioThrax Only
n=67 participants at risk
BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/38 • Number of events 1 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
2.6%
1/39 • Number of events 1 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
7.5%
5/67 • Number of events 9 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
|
General disorders
Fatigue
|
0.00%
0/38 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
5.1%
2/39 • Number of events 4 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
4.5%
3/67 • Number of events 4 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
|
General disorders
Injection site erythema
|
5.3%
2/38 • Number of events 2 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
0.00%
0/39 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
3.0%
2/67 • Number of events 3 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
|
General disorders
Injection site mass
|
0.00%
0/38 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
0.00%
0/39 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
6.0%
4/67 • Number of events 5 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
|
General disorders
Injection site pain
|
0.00%
0/38 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
0.00%
0/39 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
6.0%
4/67 • Number of events 6 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
1/38 • Number of events 1 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
5.1%
2/39 • Number of events 2 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
4.5%
3/67 • Number of events 3 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
2/38 • Number of events 2 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
0.00%
0/39 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
1.5%
1/67 • Number of events 1 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/38 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
0.00%
0/39 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
7.5%
5/67 • Number of events 6 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
|
Nervous system disorders
Headache
|
7.9%
3/38 • Number of events 3 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
10.3%
4/39 • Number of events 4 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
6.0%
4/67 • Number of events 5 • Arm 1: enrollment, Days 0-5, 20, 34, 39-44, 48, or the early withdrawal visit (EWV) for a max of 16 visits. Arm 2: enrollment, Days 1, 5, 20, 34, 48, or EWV for a max of 6 visits. Arm 3: enrollment, Days 1, 15, 29, 43, or EWV for a max of 5 visits.
Subjects in the safety (treated) population were asked about adverse event (AEs) at each visit. Severe (Grade 3) injection site and systemic reactions recorded in subject diaries were also recorded as AEs in the eCRF. Abnormal lab results, vital signs, and physical examination findings considered clinically significant were also recorded as AEs.
|
Additional Information
Robert Hopkins, MD, MPH & TM, FACP, FIDSA, Medical Monitor
Emergent BioSolutions
Phone: 301-944-0136
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor is responsible for public disclosure of study data. Any proposed publication is subject to review agreed between the Biomedical Advanced Research \& Development Authority (BARDA) and Emergent; between Emergent and the contract research organizations (CROs)/vendors; and between the CROs and the site Principal Investigator. Data are the property of the sponsor and cannot be published without prior authorization from the sponsor, but data and publication thereof will not be unduly withheld.
- Publication restrictions are in place
Restriction type: OTHER