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Trial record 1 of 27 for:    acam2000 | Smallpox | Phase 2
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Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

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ClinicalTrials.gov Identifier: NCT00053482
Recruitment Status : Completed
First Posted : January 31, 2003
Results First Posted : February 11, 2011
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Smallpox
Interventions Biological: ACAM2000 Smallpox Vaccine
Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
Enrollment 357
Recruitment Details Participants were enrolled from 07 January 2003 to 31 March 2003 in 3 medical centers in the US.
Pre-assignment Details A total of 357 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Hide Arm/Group Description Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0 Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0 Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0 Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Period Title: Overall Study
Started 51 102 102 50 52
Completed 51 102 102 50 52
Not Completed 0 0 0 0 0
Arm/Group Title ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine Total
Hide Arm/Group Description Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0 Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0 Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0 Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 Total of all reporting groups
Overall Number of Baseline Participants 51 102 102 50 52 357
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 102 participants 102 participants 50 participants 52 participants 357 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
 100.0%
102
 100.0%
102
 100.0%
50
 100.0%
52
 100.0%
357
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 102 participants 102 participants 50 participants 52 participants 357 participants
48  (9.7) 48  (10.1) 50  (11.7) 47  (9.1) 48  (9.2) 48  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 102 participants 102 participants 50 participants 52 participants 357 participants
Female
27
  52.9%
57
  55.9%
54
  52.9%
18
  36.0%
19
  36.5%
175
  49.0%
Male
24
  47.1%
45
  44.1%
48
  47.1%
32
  64.0%
33
  63.5%
182
  51.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 51 participants 102 participants 102 participants 50 participants 52 participants 357 participants
51 102 102 50 52 357
1.Primary Outcome
Title The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Hide Description The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)
Time Frame Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The neutralizing antibody response titers were assessed in the antibody evaluable, per-protocol population.
Arm/Group Title ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Hide Arm/Group Description:
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Overall Number of Participants Analyzed 51 102 102 50 52
Mean (Standard Deviation)
Unit of Measure: PRNT50 Titers
Baseline 77  (119.4) 112  (280.5) 76  (108.7) 91  (145.4) 186  (709.8)
Day 15 244  (485.4) 259  (449.1) 802  (4111.6) 546  (829.9) 1287  (2198.4)
2.Primary Outcome
Title Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Hide Description [Not Specified]
Time Frame Day 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Hide Arm/Group Description:
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Overall Number of Participants Analyzed 51 102 102 50 52
Measure Type: Number
Unit of Measure: Participants
13 31 41 38 39
3.Primary Outcome
Title Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Hide Description [Not Specified]
Time Frame Days 0 to 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Post-vaccination adverse events were assessed in the safety, intent-to-treat population.
Arm/Group Title ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Hide Arm/Group Description:
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Overall Number of Participants Analyzed 51 102 102 50 52
Measure Type: Number
Unit of Measure: Participants
Lymph Node Pain 1 1 1 1 0
Lymphadenopathy 0 0 1 0 0
Constipation 0 0 1 0 0
Toothache 0 1 0 0 0
Injection Site Erythema 0 1 3 4 3
Injection Site Pruritus 0 1 0 0 1
Injection Site Pain 0 0 0 0 1
Human Immunodeficiency Virus (HIV) Test Positive 1 0 0 0 0
Back Pain 0 1 0 0 0
Myalgia 1 0 0 0 0
Swelling Not Otherwise Specified 0 0 0 1 0
Migraine Not Otherwise Specified 0 1 0 0 0
Pregnancy Not Otherwise Specified 0 1 0 0 0
Calculus Renal Not Otherwise Specified 0 1 0 0 0
4.Other Pre-specified Outcome
Title Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Hide Description [Not Specified]
Time Frame Days 0 to 30 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment-emergent rash events were assessed in the safety intent-to-treat population.
Arm/Group Title ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Hide Arm/Group Description:
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Overall Number of Participants Analyzed 51 102 102 50 52
Measure Type: Number
Unit of Measure: Participants
Rash Not Otherwise Specified 2 5 5 5 3
Rash Macular 0 0 0 1 0
Rash Papular 0 0 1 0 0
Application Site Rash 0 0 1 1 2
Injection Site Rash 1 0 1 0 2
Any Rash 3 5 8 7 5
5.Other Pre-specified Outcome
Title Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Hide Description [Not Specified]
Time Frame Days 0 (Baseline) and 15 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The hematology parameters were assessed in the intent-to-treat safety population.
Arm/Group Title ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Hide Arm/Group Description:
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Overall Number of Participants Analyzed 51 102 102 50 52
Mean (Standard Deviation)
Unit of Measure: Percentage (%)
Hematocrit (Baseline) 41.7  (3.58) 42.4  (3.87) 42.2  (3.66) 42.8  (3.69) 43.3  (3.62)
Hematocrit (Day15) 41.2  (3.53) 41.6  (3.86) 41.5  (3.68) 42.1  (3.30) 42.8  (3.27)
Lymphocytes (Baseline) 31.8  (7.27) 30.8  (6.68) 30.6  (7.87) 30.4  (6.98) 30.9  (6.27)
Lymphocytes (Day15) 32.4  (6.88) 30.8  (7.19) 31.3  (8.26) 31.2  (7.36) 33.4  (7.00)
Eosinophils (Baseline) 2.8  (1.89) 2.5  (2.09) 2.5  (1.50) 2.3  (1.37) 2.8  (1.84)
Eosinophils (Day15) 2.5  (1.43) 2.5  (2.02) 2.6  (1.66) 2.5  (1.55) 3.1  (2.2)
6.Other Pre-specified Outcome
Title Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Hide Description [Not Specified]
Time Frame Days 0 (Baseline) and 15 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The hematology parameters were assessed in the intent-to-treat safety population.
Arm/Group Title ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Hide Arm/Group Description:
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Overall Number of Participants Analyzed 51 102 102 50 52
Mean (Standard Deviation)
Unit of Measure: x10^6th/µL
Red Blood Cell count (Baseline) 4.7  (0.35) 4.8  (0.47) 4.8  (0.46) 4.9  (0.40) 4.9  (0.45)
Red Blood Cell count (Day15) 4.7  (0.36) 4.7  (0.50) 4.7  (0.50) 4.8  (0.36) 4.8  (0.41)
Platelets (Baseline) 279  (69.7) 276  (54.5) 277  (71.5) 285  (58.4) 280  (75.7)
Platelets (Day15) 286  (66.7) 281  (61.3) 276  (67.2) 284  (63.2) 284  (77.0)
7.Other Pre-specified Outcome
Title Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Hide Description [Not Specified]
Time Frame Days 0 (Baseline) and 15 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Clinical chemistry parameters were assessed in the intent-to-treat safety population
Arm/Group Title ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Hide Arm/Group Description:
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Overall Number of Participants Analyzed 51 102 102 50 52
Mean (Standard Deviation)
Unit of Measure: mg/dL
Creatinine (Baseline) 0.90  (0.122) 0.94  (0.167) 0.92  (0.187) 0.94  (0.184) 0.97  (0.156)
Creatinine (Day 15) 0.91  (0.145) 0.96  (0.181) 0.95  (0.184) 0.96  (0.184) 0.98  (0.138)
Glucose (Baseline) 91  (11.7) 87  (8.7) 92  (15.3) 92  (13.4) 88  (10.7)
Glucose (Day 15) 94  (22.6) 90  (18.9) 90  (16.3) 94  (28.4) 95  (27.3)
8.Other Pre-specified Outcome
Title Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Hide Description [Not Specified]
Time Frame Days 0 (Baseline) and 15 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Clinical chemistry parameters were assessed in the intent-to-treat safety population
Arm/Group Title ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Hide Arm/Group Description:
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Overall Number of Participants Analyzed 51 102 102 50 52
Mean (Standard Deviation)
Unit of Measure: IU/L
Aspartate transaminase (Baseline) 27  (13.2) 24  (9.9) 23  (10.3) 22  (6.9) 22  (6.2)
Aspartate transaminase (Day 15) 24  (11.5) 23  (8.7) 24  (10.7) 21  (10.4) 21  (5.8)
Alanine transaminase (Baseline) 39  (16.3) 39  (19.5) 37  (17.3) 37  (15.7) 36  (12.9)
Alanine transaminase (Day 15) 39  (20.1) 38  (20.4) 37  (19.2) 37  (16.0) 34  (13.8)
Time Frame Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Hide Arm/Group Description Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0 Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0 Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0 Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
All-Cause Mortality
ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/51 (1.96%)      1/102 (0.98%)      0/102 (0.00%)      0/50 (0.00%)      0/52 (0.00%)    
Investigations           
HIV test positive  2  1/51 (1.96%)  1 0/102 (0.00%)  0 0/102 (0.00%)  0 0/50 (0.00%)  0 0/52 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Pregnancy Not Otherwise Specified  1  0/51 (0.00%)  0 1/102 (0.98%)  1 0/102 (0.00%)  0 0/50 (0.00%)  0 0/52 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, MedDRA 6.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ACAM2000 Dose 1 ACAM2000 Dose 2 ACAM2000 Dose 3 ACAM2000 Dose 4 Dryvax® Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/51 (94.12%)      93/102 (91.18%)      98/102 (96.08%)      49/50 (98.00%)      51/52 (98.08%)    
Blood and lymphatic system disorders           
Lymph Node Pain  1  5/51 (9.80%)  8/102 (7.84%)  20/102 (19.61%)  14/50 (28.00%)  12/52 (23.08%) 
Lymphadenopathy  1  3/51 (5.88%)  5/102 (4.90%)  6/102 (5.88%)  1/50 (2.00%)  5/52 (9.62%) 
Gastrointestinal disorders           
Diarrhea Not Otherwise Specified  1  8/51 (15.69%)  17/102 (16.67%)  11/102 (10.78%)  12/50 (24.00%)  9/52 (17.31%) 
Nausea  1  7/51 (13.73%)  8/102 (7.84%)  11/102 (10.78%)  8/50 (16.00%)  5/52 (9.62%) 
Constipation  1  4/51 (7.84%)  5/102 (4.90%)  9/102 (8.82%)  3/50 (6.00%)  3/52 (5.77%) 
General disorders           
Injection Site Pruritus  1  29/51 (56.86%)  59/102 (57.84%)  77/102 (75.49%)  38/50 (76.00%)  43/52 (82.69%) 
Injection Site Erythema  1  20/51 (39.22%)  42/102 (41.18%)  48/102 (47.06%)  24/50 (48.00%)  30/52 (57.69%) 
Fatigue  1  15/51 (29.41%)  28/102 (27.45%)  41/102 (40.20%)  18/50 (36.00%)  18/52 (34.62%) 
Malaise  1  17/51 (33.33%)  20/102 (19.61%)  29/102 (28.43%)  18/50 (36.00%)  15/52 (28.85%) 
Feeling Hot  1  12/51 (23.53%)  15/102 (14.71%)  14/102 (13.73%)  13/50 (26.00%)  6/52 (11.54%) 
Rigors  1  9/51 (17.65%)  11/102 (10.78%)  13/102 (12.75%)  10/50 (20.00%)  8/52 (15.38%) 
Injection Site Inflammation  1  0/51 (0.00%)  3/102 (2.94%)  7/102 (6.86%)  7/50 (14.00%)  11/52 (21.15%) 
Injection Site Pain  1  13/51 (25.49%)  27/102 (26.47%)  36/102 (35.29%)  16/50 (32.00%)  19/52 (36.54%) 
Infections and infestations           
Nasopharyngitis  1  1/51 (1.96%)  1/102 (0.98%)  11/102 (10.78%)  7/50 (14.00%)  3/52 (5.77%) 
Musculoskeletal and connective tissue disorders           
Myalgia  1  14/51 (27.45%)  33/102 (32.35%)  30/102 (29.41%)  15/50 (30.00%)  7/52 (13.46%) 
Back Pain  1  3/51 (5.88%)  6/102 (5.88%)  4/102 (3.92%)  1/50 (2.00%)  4/52 (7.69%) 
Nervous system disorders           
Headache Not Otherwise Specified  1  24/51 (47.06%)  39/102 (38.24%)  46/102 (45.10%)  25/50 (50.00%)  21/52 (40.38%) 
Respiratory, thoracic and mediastinal disorders           
Pharyngitis  1  3/51 (5.88%)  5/102 (4.90%)  7/102 (6.86%)  2/50 (4.00%)  2/52 (3.85%) 
Skin and subcutaneous tissue disorders           
Rash Not Otherwise Specified  1  2/51 (3.92%)  5/102 (4.90%)  5/102 (4.90%)  5/50 (10.00%)  3/52 (5.77%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6.0
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eddie Darton, Medical Director
Organization: Emergent BioSolutions
Phone: 240-631-3688
EMail: dartone@ebsi.com
Layout table for additonal information
Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT00053482    
Other Study ID Numbers: H-400-003
First Submitted: January 30, 2003
First Posted: January 31, 2003
Results First Submitted: January 3, 2011
Results First Posted: February 11, 2011
Last Update Posted: August 13, 2018