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Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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)
Arm/Group Title AVA Alone AVA+Raxibacumab Total
Hide 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
Hide 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
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population.
Arm/Group Title AVA Alone AVA+Raxibacumab
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population.
Arm/Group Title AVA Alone AVA+Raxibacumab
Hide 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)
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population.
Arm/Group Title AVA Alone AVA+Raxibacumab
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title AVA Alone AVA+Raxibacumab
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title AVA Alone AVA+Raxibacumab
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title AVA Alone AVA+Raxibacumab
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title AVA Alone AVA+Raxibacumab
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title AVA Alone AVA+Raxibacumab
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title AVA Alone AVA+Raxibacumab
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title AVA Alone AVA+Raxibacumab
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title AVA Alone AVA+Raxibacumab
Hide 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
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
Hide 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%) 
Hide 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
Hide 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
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
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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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