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A Study Evaluating Safety And Immunogenicity Of Meningococcal B Rlp2086 Vaccine In Adolescents

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: NCT00808028
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : April 14, 2015
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single;   Primary Purpose: Prevention
Condition Meningitis, Meningococcal
Interventions Biological: meningococcal B rLP2086 vaccine.
Other: normal saline (placebo)
Enrollment 538
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control rLP2086 60 Microgram (mcg) rLP2086 120 mcg rLP2086 200 mcg
Hide Arm/Group Description Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2. Given on a 0, 2-, 6-month schedule in Stage 1 Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2. Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Period Title: Stage 1 (6 Months)
Started 121 22 [1] 198 198
Completed 116 21 [1] 191 183
Not Completed 5 1 7 15
Reason Not Completed
Withdrawal by Subject             3             0             2             5
Other             1             0             2             4
Parent/legal guardian request             0             1             1             3
Adverse Event             0             0             1             2
Lost to Follow-up             1             0             1             0
Protocol Violation             0             0             0             1
[1]
Participants in rLP2086 60 mcg group participated only in Stage 1 and were not eligible for Stage 2
Period Title: Stage 2 (Followed up to 48 Months )
Started 80 [1] 0 170 151
Completed 69 [1] 0 141 128
Not Completed 11 0 29 23
Reason Not Completed
Withdrawal by Subject             6             0             9             11
Protocol Violation             0             0             1             0
Lost to Follow-up             2             0             8             7
Failed to return             2             0             5             4
Adverse Event             1             0             1             0
Other             0             0             1             1
Parent's or guardian request             0             0             2             0
Death             0             0             1             0
Non-compliance             0             0             1             0
[1]
Out of 511 completed participants in Stage 1, 89 did not enter Stage 2
Arm/Group Title Control rLP2086 60 mcg rLP2086 120 mcg rLP2086 200 mcg Total
Hide Arm/Group Description Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2. Given on a 0, 2-, 6-month schedule in Stage 1. Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2. Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2. Total of all reporting groups
Overall Number of Baseline Participants 121 22 198 198 539
Hide Baseline Analysis Population Description
The stage 1 intent-to-treat (ITT) population included all randomized participants who received at least 1 vaccination and have at least 1 valid and determinate assay result from blood samples drawn during stage 1.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 121 participants 22 participants 198 participants 198 participants 539 participants
13.8  (2.05) 13.3  (1.84) 14.3  (2.11) 14.0  (2.01) 14.0  (2.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 22 participants 198 participants 198 participants 539 participants
Female
61
  50.4%
11
  50.0%
113
  57.1%
103
  52.0%
288
  53.4%
Male
60
  49.6%
11
  50.0%
85
  42.9%
95
  48.0%
251
  46.6%
1.Primary Outcome
Title Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 2
Hide Description [Not Specified]
Time Frame Before vaccination 1 up to 1 month after vaccination 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Arm/Group Title Control-Stage 1 rLP2086 60 mcg- Stage 1 rLP2086 120 mcg- Stage 1 rLP2086 200 mcg- Stage 1
Hide Arm/Group Description:
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Overall Number of Participants Analyzed 119 22 195 192
Measure Type: Number
Unit of Measure: Percentage of participants
Subfamily A Strain A05 (N= 80, 18, 115, 106) 1.3 88.9 83.5 87.7
Subfamily B Strain B02 (N= 84, 21, 121, 114) 0.0 71.4 59.5 59.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control-Stage 1
Comments Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection rLP2086 60 mcg- Stage 1
Comments Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection rLP2086 120 mcg- Stage 1
Comments Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection rLP2086 200 mcg- Stage 1
Comments Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Control-Stage 1
Comments Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection rLP2086 60 mcg- Stage 1
Comments Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0392
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection rLP2086 120 mcg- Stage 1
Comments Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0225
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection rLP2086 200 mcg- Stage 1
Comments Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0244
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With at Least 4-fold Rise in Recombinant Lipoprotein 2086 (rLP2086) Specific Serum Bactericidal Assay Using Human Complement (hSBA) Titer: Before Vaccination 1 up to 1 Month After Vaccination 3
Hide Description [Not Specified]
Time Frame Before vaccination 1 up to 1 month after vaccination 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Arm/Group Title Control-Stage 1 rLP2086 60 mcg- Stage 1 rLP2086 120 mcg- Stage 1 rLP2086 200 mcg- Stage 1
Hide Arm/Group Description:
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Overall Number of Participants Analyzed 119 22 195 192
Measure Type: Number
Unit of Measure: Percentage of participants
Subfamily A Strain A05 (N= 73, 19, 111,100) 5.5 89.5 92.8 94.0
Subfamily B Strain B02 (N= 79, 21, 112,105) 1.3 81.0 86.6 84.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control-Stage 1
Comments Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection rLP2086 60 mcg- Stage 1
Comments Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection rLP2086 120 mcg- Stage 1
Comments Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection rLP2086 200 mcg- Stage 1
Comments Strain A05: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Control-Stage 1
Comments Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection rLP2086 60 mcg- Stage 1
Comments Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0036
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection rLP2086 120 mcg- Stage 1
Comments Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection rLP2086 200 mcg- Stage 1
Comments Strain B02: Response rate was compared with whether greater than (>) 50% of participants had fold rise >=4 using right one-sided exact test based on binomial distribution and the corresponding p-values were calculated. p-value < 0.025 was considered significant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial Distribution
Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants With Atleast One Adverse Event (AE): Stage 1
Hide Description [Not Specified]
Time Frame Vaccination 1 upto 1 Month after vaccination 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included participants who received at least 1 dose of study vaccine.
Arm/Group Title Control-Stage 1 rLP2086 60 mcg- Stage 1 rLP2086 120 mcg- Stage 1 rLP2086 200 mcg- Stage 1
Hide Arm/Group Description:
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Overall Number of Participants Analyzed 121 22 198 195
Measure Type: Number
Unit of Measure: Percentage of participants
Stage 1: Vaccination phase 44.6 81.8 38.9 47.2
Stage 1: 6-month follow up phase 4.1 18.2 1.5 2.6
4.Primary Outcome
Title Percentage of Participants With Atleast One Adverse Event (AE): Stage 2
Hide Description [Not Specified]
Time Frame 6 month after vaccination 3 up to 48 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included participants who received at least 1 dose of study vaccine.
Arm/Group Title Control- Stage 2 rLP2086 120 mcg- Stage 2 rLP2086 200 mcg- Stage 2
Hide Arm/Group Description:
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
Overall Number of Participants Analyzed 80 170 151
Measure Type: Number
Unit of Measure: Percentage of participants
2.5 4.1 2.0
5.Secondary Outcome
Title Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level Greater Than or Equal To (>=) Prespecified Titer Level
Hide Description [Not Specified]
Time Frame 1 month before vaccination 1, 1 month after vaccination 2, 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Arm/Group Title Control-Stage 1 rLP2086 60 mcg- Stage 1 rLP2086 120 mcg- Stage 1 rLP2086 200 mcg- Stage 1
Hide Arm/Group Description:
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Overall Number of Participants Analyzed 119 22 195 192
Measure Type: Number
Unit of Measure: Percentage of participants
A04 Predose 1;1:32 (N= 64, 15, 90, 92) 10.9 0.0 10.0 12.0
A04 Predose 1;1:64 (N= 64, 15, 90, 92) 3.1 0.0 7.8 5.4
A04 Predose 1;1:128 (N= 64, 15, 90, 92) 0.0 0.0 1.1 0.0
A04 1-month postdose 2;1:32 (N= 69, 21, 115, 115) 4.3 95.2 98.3 91.3
A04 1-month postdose 2;1:64 (N= 69, 21, 115, 115) 1.4 85.7 82.6 72.2
A04 1-month postdose 2;1:128 (N= 69, 21, 115, 115) 1.4 52.4 44.3 42.6
A05 Predose 1;1:16 (N= 81, 21, 122, 114) 12.3 4.8 9.0 6.1
A05 Predose 1;1:32 (N= 81, 21, 122, 114) 7.4 4.8 5.7 4.4
A05 Predose 1;1:64 (N= 81, 21, 122, 114) 4.9 0.0 2.5 1.8
A05 Predose 1;1:128 (N= 81, 21, 122, 114) 1.2 0.0 0.8 0.0
A05 1-month postdose 2;1:16 (N= 83, 18, 118, 110) 7.2 88.9 89.0 90.9
A05 1-month postdose 2;1:32 (N= 83, 18, 118, 110) 3.6 88.9 85.6 81.8
A05 1-month postdose 2;1:64 (N= 83, 18, 118, 110) 1.2 83.3 59.3 64.5
A05 1-month postdose 2;1:128 (N= 83, 18, 118, 110) 0.0 33.3 28.0 40.0
A05 1-month postdose 3;1:16 (N= 76, 20, 114, 104) 11.8 90.0 96.5 96.2
A05 1-month postdose 3;1:32 (N= 76, 20, 114, 104) 7.9 90.0 94.7 95.2
A05 1-month postdose 3;1:64 (N= 76, 20, 114, 104) 3.9 85.0 89.5 87.5
A05 1-month postdose 3;1:128 (N= 76, 20, 114, 104) 1.3 40.0 68.4 60.6
A56 Predose 1;1:16 (N= 80, 21, 119, 115) 10.0 4.8 7.6 6.1
A56 Predose 1;1:32 (N= 80, 21, 119, 115) 7.5 4.8 5.0 4.3
A56 Predose 1;1:64 (N= 80, 21, 119, 115) 2.5 0.0 0.8 3.5
A56 Predose 1;1:128 (N= 80, 21, 119, 115) 1.3 0.0 0.0 0.0
A56 1-month postdose 2;1:16 (N= 81, 20, 117, 107) 12.3 85.0 94.9 96.3
A56 1-month postdose 2;1:32 (N= 81, 20, 117, 107) 11.1 85.0 90.6 88.8
A56 1-month postdose 2;1:64 (N= 81, 20, 117, 107) 9.9 80.0 80.3 71.0
A56 1-month postdose 2;1:128 (N= 81, 20, 117, 107) 2.5 45.0 39.3 45.8
A56 1-month postdose 3 ;1:16 (N= 78, 21, 114, 112) 11.5 95.2 97.4 95.5
A56 1-month postdose 3 ;1:32 (N= 78, 21, 114, 112) 9.0 85.7 93.9 93.8
A56 1-month postdose 3 ;1:64 (n= 78, 21, 114, 112) 3.8 71.4 91.2 84.8
A56 1-month postdose 3;1:128 (N= 78, 21, 114, 112) 2.6 61.9 74.6 67.0
B02 postdose 1;1:16 (N= 84, 22, 124, 118) 3.6 0.0 1.6 2.5
B02 postdose 1;1:32 (N= 84, 22, 124, 118) 1.2 0.0 0.8 1.7
B02 postdose 1;1:64 (N= 84, 22, 124, 118) 0.0 0.0 0.8 0.0
B02 postdose 1;1:128 (N= 84, 22, 124, 118) 0.0 0.0 0.8 0.0
B02 1-month postdose 2 ;1:16 (N= 84, 21, 122, 114) 1.2 76.2 68.9 65.8
B02 1-month postdose 2 ;1:32 (N= 84, 21, 122, 114) 0.0 57.1 45.9 48.2
B02 1-month postdose 2 ;1:64 (N= 84, 21, 122, 114) 0.0 42.9 25.4 21.9
B02 1-month postdose 2;1:128 (N= 84, 21, 122, 114) 0.0 14.3 7.4 8.8
B02 1-month postdose 3 ;1:16 (N= 79, 21, 113, 105) 3.8 85.7 90.3 85.7
B02 1-month postdose 3 ;1:32 (N= 79, 21, 113, 105) 1.3 81.0 78.8 79.0
B02 1-month postdose 3 ;1:64 (N= 79, 21, 113, 105) 0.0 57.1 52.2 60.0
B02 1-month postdose 3;1:128 (N= 79, 21, 113, 105) 0.0 42.9 19.5 19.0
B03 Predose 1;1:16 (N= 83, 22, 118, 117) 2.4 0.0 2.5 2.6
B03 Predose 1;1:32 (N= 83, 22, 118, 117) 2.4 0.0 2.5 2.6
B03 Predose 1;1:64 (N= 83, 22, 118, 117) 1.2 0.0 0.0 0.9
B03 Predose 1;1:128 (N= 83, 22, 118, 117) 0.0 0.0 0.0 0.0
B03 1-month postdose 2;1:16 (N= 84, 19, 102, 96) 2.4 21.1 32.4 30.2
B03 1-month postdose 2;1:32 (N= 84, 19, 102, 96) 2.4 21.1 30.4 28.1
B03 1-month postdose 2;1:64 (N= 84, 19, 102, 96) 1.2 5.3 22.5 19.8
B03 1-month postdose 2;1:128 (N= 84, 19, 102, 96) 0.0 0.0 10.8 2.3
B03 1-month postdose 3;1:16 (N= 68, 15, 86, 81) 5.9 53.3 75.6 67.9
B03 1-month postdose 3;1:32 (N= 68, 15, 86, 81) 4.4 53.3 75.6 66.7
B03 1-month postdose 3;1:64 (N= 68, 15, 86, 81) 1.5 46.7 60.5 58.0
B03 1-month postdose 3;1:128 (N= 68, 15, 86, 81) 0.0 26.7 27.9 24.7
B44 Predose 1 ;1:8 (N= 81, 22, 120, 116) 2.5 0.0 3.3 2.6
B44 Predose 1 ;1:16 (N= 81, 22, 120, 116) 1.2 0.0 1.7 2.6
B44 Predose 1 ;1:32 (N= 81, 22, 120, 116) 0.0 0.0 0.0 1.7
B44 Predose 1 ;1:64 (N= 81, 22, 120, 116) 0.0 0.0 0.0 0.9
B44 Predose 1 ;1:128 (N= 81, 22, 120, 116) 0.0 0.0 0.0 0.9
B44 1-month postdose 2;1:8 (n= 81, 21, 115, 106) 1.2 61.9 68.7 70.8
B44 1-month postdose 2;1:16 (N= 81, 21, 115, 106) 0.0 61.9 60.9 64.2
B44 1-month postdose 2;1:32 (N= 81, 21, 115, 106) 0.0 47.6 43.5 42.5
B44 1-month postdose 2;1:64 (N= 81, 21, 115, 106) 0.0 23.8 22.6 25.5
B44 1-month postdose 2;1:128 (N= 81, 21, 115, 106) 0.0 0.0 6.1 11.3
B44 1-month postdose 3;1:8 (N= 83, 21, 115, 111) 4.8 76.2 88.7 86.5
B44 1-month postdose 3; 1:16 (N= 83, 21, 115, 111) 1.2 76.2 86.1 85.6
B44 1-month postdose 3;1:32 (N= 83, 21, 115, 111) 0.0 76.2 80.9 80.2
B44 1-month postdose 3;1:64 (N= 83, 21, 115, 111) 0.0 47.6 53.9 61.3
B44 1-month postdose 3;1:128 (N= 83, 21, 115, 111) 0.0 9.5 22.6 19.8
6.Other Pre-specified Outcome
Title Immunogloblulin G (IgG) Measured by Geometric Mean Titer (GMT) for Sub Family A and Sub Family B
Hide Description [Not Specified]
Time Frame Before Vaccination 1, 1 month after vaccination 2, 1 month after vaccination 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants who received at least 1 vaccination and had at least 1 valid and determinate assay result. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
Arm/Group Title Control-Stage 1 rLP2086 60 mcg- Stage 1 rLP2086 120 mcg- Stage 1 rLP2086 200 mcg- Stage 1
Hide Arm/Group Description:
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
Overall Number of Participants Analyzed 119 22 195 192
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Subfamily(Sf) A Predose 1(N=106,22,156,173)
3.6
(2.6 to 5.1)
4.3
(1.6 to 11.7)
7.2
(5.3 to 9.8)
4.9
(3.8 to 6.4)
Sf A 1-month postdose 2(N=104, 22,168,166)
4.9
(3.5 to 6.9)
984.6
(663.8 to 1460.4)
1115.5
(962.8 to 1292.5)
1285.8
(1082.3 to 1527.7)
Sf A 1-month postdose 3(N=98,20, 158,148)
5.8
(3.9 to 8.5)
3120.3
(1959.5 to 4968.8)
2289.5
(1967.0 to 2664.9)
2342.6
(2003.9 to 2738.5)
Sf B Predose 1(N= 106,22,155,172)
3.5
(2.6 to 4.6)
4.2
(1.4 to 12.7)
5.4
(4.1 to 7.2)
3.9
(3.0 to 5.0)
Sf B 1-month postdose 2(N=104, 22,168,166)
3.7
(2.7 to 5.0)
405.8
(298.7 to 551.4)
816.5
(701.0 to 951.1)
852.0
(729.1 to 995.6)
Sf B 1-month postdose 3(N=98,20,158,148)
4.1
(2.9 to 5.7)
3264.2
(2502.3 to 4258.1)
2246.8
(1988.1 to 2539.2)
2553.3
(2256.0 to 2889.7)
Time Frame AE reported from Vaccination 1 upto 48 months after vaccincation 3 and SAE reported from Vaccination 1 upto 48 months after vaccincation 3
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control- Stage 1 rLP2086 60 mcg- Stage 1 rLP2086 120 mcg- Stage 1 rLP2086 200 mcg- Stage 1 Control-Stage 1 Follow-up rLP2086 60 mcg- Stage 1 Follow up rLP2086 120 mcg- Stage 1 Follow up rLP2086 200 mcg- Stage 1 Follow up Control-Stage 2 rLP2086 120 mcg- Stage 2 rLP2086 200 mcg- Stage 2
Hide Arm/Group Description Given on a 0, 2-, 6-month schedule in Stage 1 Given on a 0, 2-, 6-month schedule in Stage 1 Given on a 0, 2-, 6-month schedule in Stage 1 Given on a 0, 2-, 6-month schedule in Stage 1 Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2 Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2 Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
All-Cause Mortality
Control- Stage 1 rLP2086 60 mcg- Stage 1 rLP2086 120 mcg- Stage 1 rLP2086 200 mcg- Stage 1 Control-Stage 1 Follow-up rLP2086 60 mcg- Stage 1 Follow up rLP2086 120 mcg- Stage 1 Follow up rLP2086 200 mcg- Stage 1 Follow up Control-Stage 2 rLP2086 120 mcg- Stage 2 rLP2086 200 mcg- Stage 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control- Stage 1 rLP2086 60 mcg- Stage 1 rLP2086 120 mcg- Stage 1 rLP2086 200 mcg- Stage 1 Control-Stage 1 Follow-up rLP2086 60 mcg- Stage 1 Follow up rLP2086 120 mcg- Stage 1 Follow up rLP2086 200 mcg- Stage 1 Follow up Control-Stage 2 rLP2086 120 mcg- Stage 2 rLP2086 200 mcg- Stage 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/121 (2.48%)   1/22 (4.55%)   3/198 (1.52%)   8/195 (4.10%)   0/121 (0.00%)   1/22 (4.55%)   1/198 (0.51%)   2/195 (1.03%)   1/80 (1.25%)   6/170 (3.53%)   3/151 (1.99%) 
Blood and lymphatic system disorders                       
Lymphadenitis * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Immune system disorders                       
Anaphylactic reaction * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Infections and infestations                       
Eczema impetiginous * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  1/170 (0.59%)  0/151 (0.00%) 
Perirectal abscess * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  1/80 (1.25%)  0/170 (0.00%)  0/151 (0.00%) 
Pilonidal cyst * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  1/151 (0.66%) 
Tonsillitis * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  1/170 (0.59%)  0/151 (0.00%) 
Tonsillitis streptococcal * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  1/151 (0.66%) 
Gastroenteritis * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Sinusitis * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Appendicitis * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Mononucleosis syndrome * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Pneumonia * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Injury, poisoning and procedural complications                       
Alcohol poisoning * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  1/170 (0.59%)  0/151 (0.00%) 
Head injury * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  1/170 (0.59%)  0/151 (0.00%) 
Ligament sprain * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  1/151 (0.66%) 
Road traffic accident * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  1/170 (0.59%)  0/151 (0.00%) 
Hand fracture * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Abdominal injury * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Chest injury * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Concussion * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Forearm fracture * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Jaw fracture * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Limb injury * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
CNS germinoma * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  1/170 (0.59%)  0/151 (0.00%) 
Cerebellar tumour * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Nervous system disorders                       
Headache * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Psychiatric disorders                       
Depression * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  1/170 (0.59%)  0/151 (0.00%) 
Reproductive system and breast disorders                       
Ovarian cyst * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
Asthma * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Cough * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Rhinitis allergic * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Vascular disorders                       
Hypertension * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control- Stage 1 rLP2086 60 mcg- Stage 1 rLP2086 120 mcg- Stage 1 rLP2086 200 mcg- Stage 1 Control-Stage 1 Follow-up rLP2086 60 mcg- Stage 1 Follow up rLP2086 120 mcg- Stage 1 Follow up rLP2086 200 mcg- Stage 1 Follow up Control-Stage 2 rLP2086 120 mcg- Stage 2 rLP2086 200 mcg- Stage 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   54/121 (44.63%)   18/22 (81.82%)   75/198 (37.88%)   91/195 (46.67%)   5/121 (4.13%)   3/22 (13.64%)   2/198 (1.01%)   4/195 (2.05%)   1/80 (1.25%)   1/170 (0.59%)   0/151 (0.00%) 
Blood and lymphatic system disorders                       
Lymphadenopathy * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Cardiac disorders                       
Palpitations * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Congenital, familial and genetic disorders                       
Factor V Leiden mutation * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  1/170 (0.59%)  0/151 (0.00%) 
Ear and labyrinth disorders                       
Ear pain * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Vertigo * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Eye disorders                       
Conjunctivitis * 1  0/121 (0.00%)  0/22 (0.00%)  3/198 (1.52%)  2/195 (1.03%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Eye inflammation * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Eyelid cyst * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Photophobia * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Gastrointestinal disorders                       
Abdominal pain * 1  2/121 (1.65%)  0/22 (0.00%)  2/198 (1.01%)  3/195 (1.54%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Diarrhoea * 1  0/121 (0.00%)  1/22 (4.55%)  1/198 (0.51%)  4/195 (2.05%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Dyspepsia * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Glossodynia * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Dental caries * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Food poisoning * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Gingivitis * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Inguinal hernia * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Irritable bowel syndrome * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Mouth ulceration * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Tooth impacted * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Toothache * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Vomiting * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
General disorders                       
Influenza like illness * 1  4/121 (3.31%)  1/22 (4.55%)  2/198 (1.01%)  4/195 (2.05%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Injection site pain * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  3/195 (1.54%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Pyrexia * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  2/195 (1.03%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Injection site swelling * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Chest pain * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Hypothermia * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Injection site dermatitis * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Injection site erythema * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Injection site haematoma * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Injection site pallor * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Injection site paraesthesia * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Injection site pruritus * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Vaccination site pallor * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Vessel puncture site haematoma * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Immune system disorders                       
Allergy to animal * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Allergy to chemicals * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Seasonal allergy * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Infections and infestations                       
Gastroenteritis viral * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Otitis media * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Upper respiratory tract infection * 1  20/121 (16.53%)  13/22 (59.09%)  28/198 (14.14%)  21/195 (10.77%)  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Urinary tract infection * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  3/195 (1.54%)  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Pharyngitis * 1  5/121 (4.13%)  0/22 (0.00%)  4/198 (2.02%)  10/195 (5.13%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Gastroenteritis * 1  3/121 (2.48%)  0/22 (0.00%)  5/198 (2.53%)  4/195 (2.05%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Nasopharyngitis * 1  0/121 (0.00%)  0/22 (0.00%)  8/198 (4.04%)  3/195 (1.54%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Bronchitis * 1  1/121 (0.83%)  0/22 (0.00%)  3/198 (1.52%)  4/195 (2.05%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Respiratory tract infection * 1  4/121 (3.31%)  0/22 (0.00%)  2/198 (1.01%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Rhinitis * 1  1/121 (0.83%)  0/22 (0.00%)  4/198 (2.02%)  2/195 (1.03%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Viral infection * 1  2/121 (1.65%)  4/22 (18.18%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Ear infection * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  2/195 (1.03%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Influenza * 1  1/121 (0.83%)  0/22 (0.00%)  1/198 (0.51%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Laryngitis * 1  0/121 (0.00%)  1/22 (4.55%)  1/198 (0.51%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Lower respiratory tract infection * 1  3/121 (2.48%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Acute tonsillitis * 1  1/121 (0.83%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
H1N1 influenza * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Mumps * 1  0/121 (0.00%)  0/22 (0.00%)  2/198 (1.01%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Tonsillitis * 1  1/121 (0.83%)  1/22 (4.55%)  5/198 (2.53%)  7/195 (3.59%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Respiratory tract infection viral * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Sinusitis * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Acarodermatitis * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Cellulitis * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Gastritis viral * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Herpes simplex * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Impetigo * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Pertussis * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Pneumonia * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Pulpitis dental * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Pyelonephritis * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Subcutaneous abscess * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Viral upper respiratory tract infection * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Injury, poisoning and procedural complications                       
Head injury * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Soft tissue injury * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  2/195 (1.03%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Thermal burn * 1  1/121 (0.83%)  1/22 (4.55%)  1/198 (0.51%)  1/195 (0.51%)  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Contusion * 1  2/121 (1.65%)  1/22 (4.55%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Skin laceration * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  2/195 (1.03%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Arthropod bite * 1  1/121 (0.83%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Concussion * 1  2/121 (1.65%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Foot fracture * 1  1/121 (0.83%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Joint sprain * 1  1/121 (0.83%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Procedural pain * 1  0/121 (0.00%)  0/22 (0.00%)  2/198 (1.01%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Radius fracture * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Road traffic accident * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Whiplash injury * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Wrist fracture * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Ankle fracture * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Back injury * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Chemical burn of skin * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Chest injury * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Foreign body * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Ligament injury * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Post concussion syndrome * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Post procedural haematoma * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Skeletal injury * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Hand fracture * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Limb injury * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Upper limb fracture * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Investigations                       
Blood iron decreased * 1  0/121 (0.00%)  0/22 (0.00%)  2/198 (1.01%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Electrocardiogram QT prolonged * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Metabolism and nutrition disorders                       
Decreased appetite * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Musculoskeletal and connective tissue disorders                       
Myalgia * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Arthralgia * 1  1/121 (0.83%)  0/22 (0.00%)  1/198 (0.51%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Back pain * 1  0/121 (0.00%)  1/22 (4.55%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Arthropathy * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Costochondritis * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Muscle contracture * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Neck pain * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Pain in extremity * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Tendonitis * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Torticollis * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Rheumatoid arthritis * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  1/80 (1.25%)  0/170 (0.00%)  0/151 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                       
Fibroma * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Nervous system disorders                       
Headache * 1  8/121 (6.61%)  2/22 (9.09%)  3/198 (1.52%)  2/195 (1.03%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Syncope * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  4/195 (2.05%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Migraine * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Burning sensation mucosal * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Presyncope * 1  0/121 (0.00%)  1/22 (4.55%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Tremor * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Psychiatric disorders                       
Abnormal behaviour * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Reproductive system and breast disorders                       
Dysmenorrhoea * 1  2/121 (1.65%)  0/22 (0.00%)  0/198 (0.00%)  2/195 (1.03%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Penile discharge * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Respiratory, thoracic and mediastinal disorders                       
Oropharyngeal pain * 1  4/121 (3.31%)  2/22 (9.09%)  2/198 (1.01%)  4/195 (2.05%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Rhinorrhoea * 1  6/121 (4.96%)  0/22 (0.00%)  3/198 (1.52%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Asthma * 1  0/121 (0.00%)  0/22 (0.00%)  2/198 (1.01%)  2/195 (1.03%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Asthma exercise induced * 1  0/121 (0.00%)  1/22 (4.55%)  1/198 (0.51%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Epistaxis * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Cough * 1  3/121 (2.48%)  1/22 (4.55%)  2/198 (1.01%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Skin and subcutaneous tissue disorders                       
Acne * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Rash * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Dermatitis * 1  1/121 (0.83%)  0/22 (0.00%)  1/198 (0.51%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Dermatitis allergic * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Scar * 1  0/121 (0.00%)  1/22 (4.55%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Alopecia * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Dermatitis atopic * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Dermatitis contact * 1  0/121 (0.00%)  0/22 (0.00%)  1/198 (0.51%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Drug eruption * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Hangnail * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Ingrowing nail * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Photosensitivity reaction * 1  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  1/195 (0.51%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
Urticaria * 1  1/121 (0.83%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/121 (0.00%)  0/22 (0.00%)  0/198 (0.00%)  0/195 (0.00%)  0/80 (0.00%)  0/170 (0.00%)  0/151 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00808028     History of Changes
Other Study ID Numbers: 6108A1-2001
B1971005 ( Other Identifier: Alias Study Number )
2008-007789-51 ( EudraCT Number )
First Submitted: December 12, 2008
First Posted: December 15, 2008
Results First Submitted: March 27, 2015
Results First Posted: April 14, 2015
Last Update Posted: April 14, 2015