Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed

• ClinicalTrials.gov Identifier: NCT02339155
• Recruitment Status: Completed
• First Posted: January 15, 2015
• Results First Posted: January 9, 2018
• Last Update Posted: July 15, 2021
• Sponsor: Emergent BioSolutions
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): Emergent BioSolutions

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Infections, Bacterial
• Interventions: Biological: AVA; Biological: Raxibacumab; Drug: Diphenhydramine
• Enrollment: 573

Participant Flow

Recruitment Details	This study included healthy volunteers who were not previously immunized against protective antigen. 573 participants were randomized with 566 receiving study treatment and 537 completed the study.
Pre-assignment Details	A total of 573 participants were randomized with 566 receiving study treatment and 537 completed the study.

Arm/Group Title	AVA Alone	AVA+Raxibacumab
Arm/Group Description	Participants administered Anthrax vaccine adsorbed (AVA) subcutaneous (SC) 0.5 milliliter (mL) on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29. with the first AVA dose administered immediately after completion of a single 40 milligram/kilogram (mg/kg) intravenous (IV) infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Period Title: Overall Study
Started [1]	287	286
Received Study Treatment	286	280
Completed	272	265
Not Completed	15	21
Reason Not Completed
Adverse Event	0	6
Death	1	1
Lost to Follow-up	8	9
Physician Decision	2	1
Withdrawal by Subject	4	4
[1] This includes Intent-to-treat population (ITT)

Baseline Characteristics

Arm/Group Title		AVA Alone	AVA+Raxibacumab	Total
Arm/Group Description		Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.	Total of all reporting groups
Overall Number of Baseline Participants		287	286	573
Baseline Analysis Population Description		The Intent to Treat (ITT) Population comprised of all randomized participants
Age, Continuous [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	287 participants	286 participants	573 participants
		36.2 (12.78)	36.1 (12.06)	36.2 (12.42)
		[1] Measure Analysis Population Description: The ITT Population comprised of all randomized participants
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	287 participants	286 participants	573 participants
	Female	150 52.3%	142 49.7%	292 51.0%
	Male	137 47.7%	144 50.3%	281 49.0%
		[1] Measure Analysis Population Description: ITT
Race/Ethnicity, Customized [1]; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	287 participants	286 participants	573 participants
White		216 75.3%	221 77.3%	437 76.3%
Black or African American		61 21.3%	56 19.6%	117 20.4%
American Indian or Alaska Native		7 2.4%	1 0.3%	8 1.4%
Asian		2 0.7%	5 1.7%	7 1.2%
Multiple		1 0.3%	2 0.7%	3 0.5%
Unknown		0 0.0%	1 0.3%	1 0.2%
		[1] Measure Analysis Population Description: ITT

Outcome Measures

1. Primary Outcome

Title	Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose), Between the AVA Alone and the AVA With Raxibacumab Treatment Groups
Description	Ratio of the GMC of anti-PA Ab between AVA alone and the AVA with raxibacumab treatment group was assessed to compare the immunogenicity of AVA at 4 weeks after the first AVA dose (prior to the third AVA dose). Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. Per Protocol (PP) population was used in analysis which comprised of all analyzable participants (those who received at least the Week 0 [Day 1] and Week 2 [Day 15] AVA doses within the protocol specified visit window; receive the raxibacumab dose, if randomized to Treatment Group 2 and; completed the primary study endpoint assessment [anti-PA Ab concentration at Week 4]).
Time Frame	Day 29

Outcome Measure Data

Analysis Population Description

PP Population.

Arm/Group Title	AVA Alone	AVA+Raxibacumab
Arm/Group Description:	Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Overall Number of Participants Analyzed	276	269
Geometric Mean (95% Confidence Interval); Unit of Measure: Microgram/milliliter (µg/mL)
	26.516; (23.580 to 29.816)	22.477; (20.098 to 25.137)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AVA Alone, AVA+Raxibacumab
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper bound of the 90% confidence interval (CI) or the ratio of anti-PA Ab (attributable to AVA) GMCs between the AVA and the AVA + raxibacumab groups at Week 4 is less than 1.5, non-inferiority was to be established.
Statistical Test of Hypothesis	P-Value	0.0016
	Comments	[Not Specified]
	Method	t-test, 1 sided
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	1.18
	Confidence Interval	(2-Sided) 90%; 1.03 to 1.35
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups
Description	Anti-PA antibody concentrations were collected at Weeks 8 and 26 after the first AVA dose. Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. The GMCs with corresponding 95% CI were calculated for each treatment group at each timepoint. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time Frame	Days 57 and 183

Outcome Measure Data

Analysis Population Description

PP Population.

Arm/Group Title		AVA Alone	AVA+Raxibacumab
Arm/Group Description:		Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Overall Number of Participants Analyzed		275	267
Geometric Mean (95% Confidence Interval); Unit of Measure: µg/mL
Week 8, n=275, 267	Number Analyzed	275 participants	267 participants
		50.470; (46.124 to 55.224)	46.095; (41.860 to 50.757)
Week 26, n=267, 258	Number Analyzed	267 participants	258 participants
		10.007; (9.243 to 10.835)	10.231; (9.479 to 11.042)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AVA Alone, AVA+Raxibacumab
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	t-test, 1 sided
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 90%; 0.98 to 1.22
	Estimation Comments	Week 8

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	AVA Alone, AVA+Raxibacumab
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	t-test, 1 sided
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Ratio
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 90%; 0.89 to 1.07
	Estimation Comments	Week 26

3. Secondary Outcome

Title	Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups
Description	The percentage of participants, with corresponding 95% CI based on Wilson's method, who seroconvert (seroconversion is defined as a >4-fold increase in toxin neutralizing activity [TNA] titer) was summarized, at Weeks 4, 8 and 26 after the first AVA dose for both arms separately. Serum TNA titer was determined using a cell-based assay.
Time Frame	Days 29, 57 and 183

Outcome Measure Data

Analysis Population Description

PP Population.

Arm/Group Title	AVA Alone	AVA+Raxibacumab
Arm/Group Description:	Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Overall Number of Participants Analyzed	276	269
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percent of Participants
Week 4	76.4; (71.1 to 81.1)	99.3; (97.3 to 99.8)
Week 8	95.3; (92.5 to 97.5)	98.1; (96.7 to 99.6)
Week 26	31.9; (27.6 to 38.8)	32.0; (27.9 to 39.3)

4. Secondary Outcome

Title	Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE)
Description	An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important and may jeopardize the participant or may require medical or surgical intervention or events associated with liver injury and impaired liver function is categorized as SAE. The Safety population was comprised of all randomized participants who received at least one dose of AVA.
Time Frame	Up to Day 183

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	AVA Alone	AVA+Raxibacumab
Arm/Group Description:	Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Overall Number of Participants Analyzed	286	280
Measure Type: Number; Unit of Measure: Participants
Non-serious AEs	85	80
SAE	5	3

5. Secondary Outcome

Title	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
Description	SBP and DBP were measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time Frame	Baseline and up to Day 183

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title		AVA Alone	AVA+Raxibacumab
Arm/Group Description:		Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29. with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Overall Number of Participants Analyzed		286	280
Mean (Standard Deviation); Unit of Measure: Millimeter of mercury (mmHg)
SBP, Day 1, n=286, 280	Number Analyzed	286 participants	280 participants
		-3.4 (9.2)	-3.8 (9.6)
SBP, Day 29, n=283, 279	Number Analyzed	283 participants	279 participants
		0.6 (9.9)	1.9 (9.9)
SBP, Day 57, n=282, 275	Number Analyzed	282 participants	275 participants
		1.8 (10.9)	2.2 (10.3)
SBP, Day 183, n=273, 266	Number Analyzed	273 participants	266 participants
		2.4 (10.6)	1.5 (9.9)
DBP, Day 1, n=286, 280	Number Analyzed	286 participants	280 participants
		-2.7 (6.9)	-3.1 (6.8)
DBP, Day 29, n=283, 279	Number Analyzed	283 participants	279 participants
		1.0 (7.3)	1.6 (6.5)
DBP, Day 57, n=282, 275	Number Analyzed	282 participants	275 participants
		1.9 (7.4)	2.3 (7.4)
DBP, Day 183, n=273, 266	Number Analyzed	273 participants	266 participants
		2.3 (8.4)	2.5 (7.9)

6. Secondary Outcome

Title	Change From Baseline in Heart Rate at Indicated Time Points
Description	Heart rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time Frame	Baseline and up to Day 183

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title		AVA Alone	AVA+Raxibacumab
Arm/Group Description:		Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Overall Number of Participants Analyzed		286	280
Mean (Standard Deviation); Unit of Measure: Beats per minute (bpm)
Day 1, n=286, 280	Number Analyzed	286 participants	280 participants
		-0.3 (10.4)	-0.8 (10.5)
Day 29, n=283, 279	Number Analyzed	283 participants	279 participants
		-0.4 (10.5)	-0.4 (10.5)
Day 57, n=282, 275	Number Analyzed	282 participants	275 participants
		-1.2 (10.6)	-0.9 (11.2)
Day 183, n=273, 266	Number Analyzed	273 participants	266 participants
		0.9 (11.7)	0.7 (11.5)

7. Secondary Outcome

Title	Change From Baseline in Respiratory Rate at Indicated Time Points
Description	Respiratory rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time Frame	Baseline and up to Day 183

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title		AVA Alone	AVA+Raxibacumab
Arm/Group Description:		Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Overall Number of Participants Analyzed		286	280
Mean (Standard Deviation); Unit of Measure: Breaths per minute
Day 1, n=286, 280	Number Analyzed	286 participants	280 participants
		-0.4 (1.5)	-0.3 (1.5)
Day 29, n=283, 279	Number Analyzed	283 participants	279 participants
		-0.1 (1.4)	-0.1 (1.4)
Day 57, n=282, 276	Number Analyzed	282 participants	276 participants
		-0.1 (1.5)	-0.1 (1.3)
Day 183, n=273, 266	Number Analyzed	273 participants	266 participants
		-0.3 (1.6)	-0.2 (1.5)

8. Secondary Outcome

Title	Change From Baseline in Temperature at Indicated Time Points
Description	Temperature was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time Frame	Baseline and up to Day 183

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title		AVA Alone	AVA+Raxibacumab
Arm/Group Description:		Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Overall Number of Participants Analyzed		286	280
Mean (Standard Deviation); Unit of Measure: Degree celsius
Day 1, n=286, 280	Number Analyzed	286 participants	280 participants
		-0.04 (0.26)	0.02 (0.27)
Day 29, n=283, 279	Number Analyzed	283 participants	279 participants
		-0.04 (0.24)	-0.03 (0.31)
Day 57, n=282, 276	Number Analyzed	282 participants	276 participants
		-0.05 (0.25)	-0.02 (0.25)
Day 183, n=272, 266	Number Analyzed	272 participants	266 participants
		-0.04 (0.277)	-0.01 (0.26)

9. Secondary Outcome

Title	Number of Participants With Hematology Parameters Outside Normal Range
Description	Hematology parameters included assessment of platelet count, erythrocytes, leukocytes , reticulocyte count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time Frame	Up to Day 57

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title		AVA Alone	AVA+Raxibacumab
Arm/Group Description:		Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Overall Number of Participants Analyzed		286	280
Measure Type: Number; Unit of Measure: Participants
Eosinophils 10^9/Liter (L) Low, Week 4, n=282, 278	Number Analyzed	282 participants	278 participants
		0	0
Eosinophils 10^9/L High, Week 4, n=282, 278	Number Analyzed	282 participants	278 participants
		4	6
Eosinophils 10^9/L, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		0	0
Eosinophils 10^9/L, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		7	5
Basophils 10^9/L, Low, Week 4, n=282, 278	Number Analyzed	282 participants	278 participants
		0	0
Basophils 10^9/L, High, Week 4, n=282, 278	Number Analyzed	282 participants	278 participants
		0	0
Basophils 10^9/L, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		0	0
Basophils 10^9/L, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		0	0
Hematocrit percent (%) Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		7	6
Hematocrit %, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		2	1
Hematocrit %, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		6	9
Hematocrit %, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		2	2
Hemoglobin gram/Liter (g/L) Low,Week 4,n=283, 279	Number Analyzed	283 participants	279 participants
		7	3
Hemoglobin g/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		4	1
Hemoglobin g/L, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		7	10
Hemoglobin g/L, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		3	2
Lymphocytes 10^9/L , Low, Week 4, n=282, 278	Number Analyzed	282 participants	278 participants
		3	1
Lymphocytes 10^9/L , High, Week 4, n=282, 278	Number Analyzed	282 participants	278 participants
		0	1
Lymphocytes 10^9/L, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		2	4
Lymphocytes 10^9/L, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		0	0
MCH picogram (pg), Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		2	1
MCH pg, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		0	0
MCH pg, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		2	5
MCH pg, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		0	0
MCHC g/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		3	3
MCHC g/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		19	17
MCHC g/L, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		3	7
MCHC g/L, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		16	12
MCV femtoliters (fL), Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		2	2
MCV fL, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		0	1
MCV fL, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		3	2
MCV fL, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		0	0
Monocytes 10^9/L , Low, Week 4, n=282, 278	Number Analyzed	282 participants	278 participants
		0	0
Monocytes 10^9/L, High, Week 4, n=282, 278	Number Analyzed	282 participants	278 participants
		3	2
Monocytes 10^9/L, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		0	0
Monocytes 10^9/L, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		0	1
Neutrophils 10^9/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		7	8
Neutrophils 10^9/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		3	2
Neutrophils 10^9/L, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		5	6
Neutrophils 10^9/L, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		1	6
Erythrocytes 10^12/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		6	4
Erythrocytes 10^12/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		4	7
Erythrocytes 10^12/L, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		2	8
Erythrocytes 10^12/L, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		6	3
Leukocytes 10^9/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		15	12
Leukocytes 10^9/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		2	2
Leukocytes 10^9/L, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		6	10
Leukocytes 10^9/L, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		1	5
Reticulocytes 10^12/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		1	0
Reticulocytes 10^12/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		1	3
Reticulocytes 10^12/L, Low, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		1	1
Reticulocytes 10^12/L, High, Week 8, n=281, 276	Number Analyzed	281 participants	276 participants
		5	3
Platelet 10^9/L, Low, Week 4, n=282, 279	Number Analyzed	282 participants	279 participants
		6	4
Platelet 10^9/L, High, Week 4, n=282, 279	Number Analyzed	282 participants	279 participants
		0	0
Platelet 10^9/L, Low, Week 8, n=280, 276	Number Analyzed	280 participants	276 participants
		4	4
Platelet 10^9/L, High, Week 8, n=280, 276	Number Analyzed	280 participants	276 participants
		1	0

10. Secondary Outcome

Title	Number of Participants With Clinical Chemistry Parameters Outside Normal Range
Description	Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of urea nitrogen (UN), creatinine, chloride, glucose, magnesium, total protein, potassium, chloride, total Carbon dioxide (CO2), sodium, calcium (cal), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), total and direct bilirubin ( D.bili), albumin and calculated creatinine clearance. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Time Frame	Up to Day 57

Outcome Measure Data

Analysis Population Description

Safety Population.

Arm/Group Title		AVA Alone	AVA+Raxibacumab
Arm/Group Description:		Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Overall Number of Participants Analyzed		286	280
Measure Type: Number; Unit of Measure: Participants
Albumin g/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		6	2
Albumin g/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		1	0
Albumin g/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		2	1
Albumin g/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		0	0
ALP units/liter (U/L), Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		3	5
ALP U/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		14	20
ALP U/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		2	2
ALP U/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		13	19
ALT U/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		45	44
ALT U/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		7	4
ALT U/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		39	42
ALT U/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		7	6
AST U/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		41	37
AST U/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		7	5
AST U/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		38	34
AST U/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		6	10
D.bili micromole/Liter (µmol/L) LowWeek4,n=274,263	Number Analyzed	274 participants	263 participants
		0	0
D.bili µmol/L, High, Week 4, n=274, 263	Number Analyzed	274 participants	263 participants
		5	3
D.bili µmol/L, Low, Week 8, n=274, 261	Number Analyzed	274 participants	261 participants
		0	0
D.bili µmol/L, High, Week 8, n=274, 261	Number Analyzed	274 participants	261 participants
		5	9
Bili µmol/L, Low, Week 4, n=280, 279	Number Analyzed	280 participants	279 participants
		5	4
Bili µmol/L, High, Week 4, n=280, 279	Number Analyzed	280 participants	279 participants
		1	5
Bili µmol/L, Low, Week 8, n=280, 273	Number Analyzed	280 participants	273 participants
		3	2
Bili µmol/L, High, Week 8, n=280, 273	Number Analyzed	280 participants	273 participants
		2	7
Cal,millimole/Liter (mmol/L)Low,Week 4,n=283, 279	Number Analyzed	283 participants	279 participants
		6	4
Cal mmol/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		2	4
Cal mmol/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		12	10
Cal mmol/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		0	3
Chloride mmol/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		0	0
Chloride mmol/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		19	12
Chloride mmol/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		0	0
Chloride mmol/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		12	9
CO2 mmol/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		7	11
CO2 mmol/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		14	12
CO2 mmol/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		6	14
CO2 mmol/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		10	9
Creatinine µmol/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		19	10
Creatinine µmol/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		6	3
Creatinine µmol/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		20	10
Creatinine µmol/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		7	5
GGT U/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		8	3
GGT U/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		4	3
GGT U/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		10	6
GGT U/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		4	9
Glucose mmol/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		17	14
Glucose mmol/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		16	31
Glucose mmol/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		16	16
Glucose mmol/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		21	12
Potassium mmol/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		3	2
Potassium mmol/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		1	1
Potassium mmol/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		1	2
Potassium mmol/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		2	1
Magnesium mmol/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		0	0
Magnesium mmol/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		0	2
Magnesium mmol/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		0	1
Magnesium mmol/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		0	0
Protein g/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		16	17
Protein g/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		1	2
Protein g/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		16	9
Protein g/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		4	2
Sodium mmol/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		3	6
Sodium mmol/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		1	1
Sodium mmol/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		5	6
Sodium mmol/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		2	1
Urate µmol/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		5	5
Urate µmol/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		4	5
Urate µmol/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		9	7
Urate µmol/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		4	4
UN mmol/L, Low, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		3	4
UN mmol/L, High, Week 4, n=283, 279	Number Analyzed	283 participants	279 participants
		9	7
UN mmol/L, Low, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		3	6
UN mmol/L, High, Week 8, n=282, 275	Number Analyzed	282 participants	275 participants
		8	7

11. Secondary Outcome

Title	Number of Participants With Urinalysis Parameters
Description	Urinalysis parameters included amorphous crystals, bacteria, bilirubin, calcium oxalate (Ca Ox) crystals, choriogonadotropin beta, clarity, color, crystals of Ca Ox, erythrocytes, glucose, hemoglobin, ketone bodies, ketones, leukocyte cell clumps, leukocyte esterase, leukocytes, mucous threads, nitrite, occult blood, protein, specific gravity, squamous epithelial cells, turbidity, urobilinogen, and transitional epithelial cells. In urinalysis test plus sign (+) indicates increase in the level of the parameters.
Time Frame	Day 57

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	AVA Alone	AVA+Raxibacumab
Arm/Group Description:	Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
Overall Number of Participants Analyzed	286	280
Measure Type: Number; Unit of Measure: Participants
Amorphous crystals 1+	1	5
Amorphous crystals 2+	7	1
Amorphous crystals 3+	0	3
Amorphous crystals 4+	3	4
Amorphous crystals trace	1	2
Bacteria 1+	1	2
Bacteria 2+	2	1
Bacteria 3+	0	1
Bacteria 4+	1	0
Bacteria few	2	1
Bacteria many	1	0
Bacteria mod	1	2
Bacteria Occ	3	7
Bacteria rare	5	8
Bacteria trace	2	3
Bilirubin 1+	2	3
Bilirubin negative	196	188
Bilirubin small	0	2
Ca Ox Crystals few	0	2
Ca Ox Crystals rare	2	3
Choriogonadotropin Beta negative	24	16
Choriogonadotropin Beta positive	1	0
Clarity, clear	38	44
Clarity, cloudy	8	2
Clarity turbid	1	0
Color amber	2	5
Color colorless	1	1
Color light-red	0	1
Color light-yellow	6	2
Color yellow	74	71
Crystals Ca-Ox	9	17
Erythrocytes 0-2	107	104
Erythrocytes 10-25	3	0
Erythrocytes 2-5	2	6
Erythrocytes 25-50	0	1
Erythrocytes 5-10	1	2
Erythrocytes 50-99	1	0
Erythrocytes innumerable	0	1
Erythrocytes less than 1	10	4
Erythrocytes Tntc	1	0
Glucose positive	1	0
Glucose negative	257	257
Hemoglobin +	13	18
Hemoglobin ++	0	3
Hemoglobin +++	1	2
Hemoglobin large	4	2
Hemoglobin mod	3	6
Hemoglobin negative	174	166
Hemoglobin small	13	13
Hemoglobin trace	2	1
Ketone bodies negative	114	106
Ketone bodies trace	0	4
Ketones +	1	1
Ketones ++	1	0
Ketones ++++	0	2
Ketones mod	1	0
Ketones negative	255	247
Ketones trace	0	7
Leukocyte Cell Clumps Occ	1	0
Leukocyte Cell Clumps rare	1	1
Leukocyte Esterase 1+	4	2
Leukocyte Esterase 2+	1	1
Leukocyte Esterase 3+	1	0
Leukocyte Esterase large	10	7
Leukocyte Esterase Mod	1	3
Leukocyte Esterase Moderate	1	4
Leukocyte Esterase negative	162	159
Leukocyte Esterase small	5	7
Leukocyte Esterase trace	13	10
Leukocyte +	5	0
Leukocyte ++	1	0
Leukocyte +++	1	1
Leukocyte 0-2	105	99
Leukocyte 10-25	2	2
Leukocyte 2-5	6	7
Leukocyte 25-50	0	1
Leukocyte 5-10	2	4
Leukocyte less than 1	8	5
Leukocyte large	4	5
Leukocyte mod	1	5
Leukocyte negative	187	188
Leukocyte small	2	5
Leukocyte trace	9	7
Mucous threads 2+	0	1
Mucous Threads few	24	25
Mucous Threads many	2	1
Mucous Threads Mod	1	2
Mucous Threads trace	1	2
Nitrite negative	190	190
Nitrite positive	8	3
Occult Blood 1+	1	0
Occult Blood 2+	1	2
Occult Blood 3+	0	1
Occult Blood large	5	3
Occult Blood mod	1	5
Occult Blood moderate	2	7
Occult Blood negative	163	148
Occult Blood small	22	21
Occult Blood trace	3	6
Protein +	7	10
Protein ++	2	0
Protein ++++	0	1
Protein 1+	3	4
Protein large	1	0
Protein negative	244	238
Protein non-heam	1	0
Protein trace	12	15
Specific Gravity <=1.005	1	5
Specific Gravity >=1.030	3	6
Squamous Epithelial Cells 0-2	8	3
Squamous Epithelial Cells 2-5	2	5
Squamous Epithelial Cells 5-10	2	2
Squamous Epithelial Cells <1	9	8
Turbidity clear	15	15
Turbidity cloudy	2	3
Turbidity hazy	19	16
Urobilinogen <2.0	113	111
Urobilinogen less than 2.0	33	31
Urobilinogen normal	47	46
Transitional Epithelial Cells <1	2	0

Adverse Events

Time Frame	On-treatment SAEs and non-serious AEs were collected from the start of investigational product until Day 183.
Adverse Event Reporting Description	Safety Population
Arm/Group Title	AVA Alone	Raxibacumab Only and Discontinued Due to AE During Raxibacumab Infusion	AVA + Raxibacumab With no AE During Raxibacumab Infusion That Led to Discontinuation
Arm/Group Description	Participants administered AVA SC, 0.5 mL on Days 1, 15 and 29	During the study, six of 286 raxibacumab-treated subjects (2.1%) had adverse events (AEs) to raxibacumab that required drug discontinuation, administration of additional medications for mitigation of signs and symptoms, and discontinuation from the study. This new arm is included to capture safety data for these 6 subjects.	Participants administered SC 0.5 mL of AVA doses on Days 1, 15, and 29, with the first AVA dose administered immediately after completion of a single 40 mg/kg, IV infusion of raxibacumab dose (Day 1). Participants were premedicated with 25-50 mg of diphenhydramine up to 1 hour prior to the raxibacumab infusion to reduce the risk of infusion reactions.
All-Cause Mortality
	AVA Alone	Raxibacumab Only and Discontinued Due to AE During Raxibacumab Infusion	AVA + Raxibacumab With no AE During Raxibacumab Infusion That Led to Discontinuation
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Serious Adverse Events
	AVA Alone	Raxibacumab Only and Discontinued Due to AE During Raxibacumab Infusion	AVA + Raxibacumab With no AE During Raxibacumab Infusion That Led to Discontinuation
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	5/286 (1.75%)	0/6 (0.00%)	3/280 (1.07%)
Hepatobiliary disorders
Bile Duct Stone † 1	0/286 (0.00%)	/6	1/280 (0.36%)
Cholecystitis † 1	0/286 (0.00%)	/6	1/280 (0.36%)
Cholelithiasis † 1	0/286 (0.00%)	/6	1/280 (0.36%)
Infections and infestations
Bronchitis † 1	0/286 (0.00%)	/6	1/280 (0.36%)
Injury, poisoning and procedural complications
Toxicity To Various Agents † 1	1/286 (0.35%)	/6	0/280 (0.00%)
Musculoskeletal and connective tissue disorders
Rhabdomyolysis † 1	1/286 (0.35%)	/6	0/280 (0.00%)
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous † 1	2/286 (0.70%)	/6	0/280 (0.00%)
Psychiatric disorders
Completed Suicide † 1	0/286 (0.00%)	/6	1/280 (0.36%)
Suicidal Ideation † 1	1/286 (0.35%)	/6	0/280 (0.00%)
Respiratory, thoracic and mediastinal disorders
Asphyxia † 1	0/286 (0.00%)	/6	1/280 (0.36%)
Respiratory Failure † 1	0/286 (0.00%)	/6	1/280 (0.36%)
1 Term from vocabulary, 20.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	AVA Alone	Raxibacumab Only and Discontinued Due to AE During Raxibacumab Infusion	AVA + Raxibacumab With no AE During Raxibacumab Infusion That Led to Discontinuation
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	85/286 (29.72%)	6/6 (100.00%)	80/280 (28.57%)
Blood and lymphatic system disorders
Leukocytosis † 1	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Ear and labyrinth disorders
Ear Discomfort † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Eye disorders
Visual Impairment † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Gastrointestinal disorders
Nausea † 1	6/286 (2.10%)	0/6 (0.00%)	4/280 (1.43%)
Vomiting † 1	2/286 (0.70%)	0/6 (0.00%)	2/280 (0.71%)
Toothache † 1	2/286 (0.70%)	0/6 (0.00%)	0/280 (0.00%)
Abdominal Discomfort † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Abdominal Pain Lower † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Abdominal Pain Upper † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Diarrhoea † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Gastritis † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Gastrooesophageal Reflux Disease † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Rectal Haemorrhage † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
General disorders
Injection Site Reaction † 1	18/286 (6.29%)	0/6 (0.00%)	18/280 (6.43%)
Injection Site Erythema † 1	11/286 (3.85%)	0/6 (0.00%)	13/280 (4.64%)
Injection Site Pain † 1	6/286 (2.10%)	0/6 (0.00%)	8/280 (2.86%)
Injection Site Swelling † 1	4/286 (1.40%)	0/6 (0.00%)	3/280 (1.07%)
Injection Site Pruritus † 1	4/286 (1.40%)	0/6 (0.00%)	1/280 (0.36%)
Fatigue † 1	3/286 (1.05%)	0/6 (0.00%)	1/280 (0.36%)
Injection Site Nodule † 1	1/286 (0.35%)	0/6 (0.00%)	2/280 (0.71%)
Feeling hot † 1	2/286 (0.70%)	0/6 (0.00%)	0/280 (0.00%)
Pain † 1	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Pyrexia † 1	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Asthenia † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Catheter Site Pain † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Chest Discomfort † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Induration † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Infusion Site Bruising † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Infusion Site Extravasation † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Injection Site Mass † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Injection Site Rash † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Local Swelling † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Peripheral Swelling † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Vaccination Site Reaction † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Immune system disorders
Seasonal Allergy † 1	3/286 (1.05%)	0/6 (0.00%)	1/280 (0.36%)
Hypersensitivity † 1	0/286 (0.00%)	1/6 (16.67%)	0/280 (0.00%)
Infections and infestations
Urinary Tract Infection † 1	6/286 (2.10%)	0/6 (0.00%)	2/280 (0.71%)
Upper Respiratory Tract Infection † 1	3/286 (1.05%)	0/6 (0.00%)	4/280 (1.43%)
Bronchitis † 1	2/286 (0.70%)	0/6 (0.00%)	1/280 (0.36%)
Viral Upper Respiratory Tract Infection † 1	3/286 (1.05%)	0/6 (0.00%)	0/280 (0.00%)
Influenza † 1	2/286 (0.70%)	0/6 (0.00%)	0/280 (0.00%)
Pharyngitis Streptococcal † 1	2/286 (0.70%)	0/6 (0.00%)	0/280 (0.00%)
Sinusitis † 1	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Tooth Infection † 1	2/286 (0.70%)	0/6 (0.00%)	0/280 (0.00%)
Acute Sinusitis † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Conjunctivitis † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Furuncle † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Tonsillitis † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Tooth Abscess † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Injury, poisoning and procedural complications
Ligament Sprain † 1	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Muscle Strain † 1	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Animal Bite † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Arthropod Bite † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Contusion † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Foot Fracture † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Infusion Related Reaction † 1	0/286 (0.00%)	4/6 (66.67%)	1/280 (0.36%)
Laceration † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Limb Injury † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Road Traffic Accident † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Skin Injury † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Upper Limb Fracture † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Investigations
Aspartate Aminotransferase Increased † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Blood Creatine Phosphokinase Increased † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Hepatic Enzyme Increased † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Lymphocyte Count Decreased † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Neutrophil Count Decreased † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Musculoskeletal and connective tissue disorders
Pain In Extremity † 1	3/286 (1.05%)	0/6 (0.00%)	3/280 (1.07%)
Back Pain † 1	2/286 (0.70%)	0/6 (0.00%)	2/280 (0.71%)
Arthralgia † 1	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Muscle Tightnes † 1	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Flank Pain † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Muscle Fatigue † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Muscular Weakness † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Musculoskeletal Chest Pain † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Myalgia † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Nervous system disorders
Headache † 1	6/286 (2.10%)	0/6 (0.00%)	9/280 (3.21%)
Presyncope † 1	1/286 (0.35%)	0/6 (0.00%)	3/280 (1.07%)
Nerve Compression † 1	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Paraesthesia † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Dizziness † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Dysgeusia † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Hypoaesthesia † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Psychiatric disorders
Loss Of Libido † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Anxiety † 1	0/286 (0.00%)	0/6 (0.00%)	0/280 (0.00%)
Renal and urinary disorders
Nephrolithiasis † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Respiratory, thoracic and mediastinal disorders
Nasal Congestion † 1	2/286 (0.70%)	0/6 (0.00%)	1/280 (0.36%)
Cough † 1	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Sinus Congestion † 1	2/286 (0.70%)	0/6 (0.00%)	0/280 (0.00%)
Dry Throat † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Oropharyngeal Pain † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Respiratory Tract Congestion † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Rhinorrhoea † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Throat Tightness † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Skin and subcutaneous tissue disorders
Dermatitis Contact † 1	2/286 (0.70%)	0/6 (0.00%)	0/280 (0.00%)
Erythema † 1	1/286 (0.35%)	0/6 (0.00%)	1/280 (0.36%)
Urticaria † 1	0/286 (0.00%)	1/6 (16.67%)	2/280 (0.71%)
Dermatitis † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Hyperhidrosis † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Miliaria † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Pruritus † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Pruritus Generalised † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Rash Erythematous † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
Rash Generalised † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Vascular disorders
Haematoma † 1	0/286 (0.00%)	0/6 (0.00%)	3/280 (1.07%)
Flushing † 1	1/286 (0.35%)	0/6 (0.00%)	0/280 (0.00%)
Hot Flush † 1	0/286 (0.00%)	0/6 (0.00%)	1/280 (0.36%)
1 Term from vocabulary, 20.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

• Name/Title: GSK Response Center
• Organization: GlaxoSmithKline
• Phone: 866-435-7343

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Skoura N, Wang-Jairaj J, Della Pasqua O, Chandrasekaran V, Billiard J, Yeakey A, Smith W, Steel H, Tan LK. Effect of raxibacumab on immunogenicity of Anthrax Vaccine Adsorbed: a phase 4, open-label, parallel-group, randomised non-inferiority study. Lancet Infect Dis. 2020 Aug;20(8):983-991. doi: 10.1016/S1473-3099(20)30069-4. Epub 2020 Apr 22.

• Responsible Party: Emergent BioSolutions
• ClinicalTrials.gov Identifier: NCT02339155
• Other Study ID Numbers: 201436
• First Submitted: January 12, 2015
• First Posted: January 15, 2015
• Results First Submitted: December 12, 2017
• Results First Posted: January 9, 2018
• Last Update Posted: July 15, 2021