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Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women

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: NCT01150123
Recruitment Status : Completed
First Posted : June 24, 2010
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Condition Group B Streptococcus
Interventions Biological: Group B streptococcus (GBS) vaccine- low dose
Biological: Group B streptococcus (GBS) vaccine- High dose
Biological: Placebo- Saline
Enrollment 678
Recruitment Details Subjects were enrolled at one center in Belgium
Pre-assignment Details

Group1: 5 µg-1Inj-No Adj, 5 µg-2Inj-No Adj, 20 µg-1Inj-No Adj, 20 µg-2Inj-No Adj (Cohort 1), 5 µg-1Inj-Alum, 5 µg-2Inj-Alum, 20 µg-1Inj-Alum, 20 µg-2Inj-Alum (Cohort 2).

Group 2: 5 µg-1Inj-MF59_F, 5 µg-2Inj-MF59_F, 20 µg-1Inj-MF59_F, 20 µg-2Inj-MF59_F (Cohort 3), 5 µg-1Inj-MF59_H, 5 µg-2Inj-MF59_H, 20 µg-1Inj-MF59_H, 20 µg-2Inj-MF59_H (Cohort 4)

Arm/Group Title 5 µg-1 Inj - No Adj 5 µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5 µg-1 Inj - Alum 5 µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1 5 µg-1 Inj – MF59_H 5 µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5 µg-1 Inj – MF59_F 5 µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 2
Hide Arm/Group Description Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart Subjects received two injections of placebo administered 1 month apart Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart Subjects received two injections of placebo administered 1 month apart
Period Title: Overall Study
Started 40 40 39 40 40 40 39 40 20 40 40 40 40 40 40 40 40 20
Completed 37 38 35 37 37 34 39 37 15 39 38 39 37 40 40 39 40 19
Not Completed 3 2 4 3 3 6 0 3 5 1 2 1 3 0 0 1 0 1
Reason Not Completed
Withdrawal by Subject             1             1             2             1             1             1             0             3             2             0             1             0             1             0             0             1             0             1
Lost to Follow-up             2             1             2             2             2             5             0             0             3             1             1             1             2             0             0             0             0             0
Arm/Group Title 5μg-1 Inj - No Adj 5μg-2 Inj - No Adj 20 μg-1 Inj - No Adj 20 μg-2 Inj - No Adj 5μg-1 Inj - Alum 5μg-2 Inj - Alum 20 μg-1 Inj - Alum 20 μg-2 Inj- Alum Placebo - Group 1 5μg-1 Inj –MF59_H 5μg-2 Inj –MF59_H 20 μg-1 Inj –MF59_H 20 μg-2 Inj –MF59_H 5μg-1 Inj –MF59_F 5μg-2 Inj –MF59_F 20 μg-1 Inj –MF59_F 20 μg-2 Inj-MF59_F Placebo – Group 2 Total
Hide Arm/Group Description Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart Subjects received two injections of placebo administered 1 month apart t Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart Subjects received two injections of placebo administered 1 month apart Total of all reporting groups
Overall Number of Baseline Participants 40 40 39 40 40 40 39 40 20 40 40 40 40 40 40 40 40 20 678
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 39 participants 40 participants 40 participants 40 participants 39 participants 40 participants 20 participants 40 participants 40 participants 40 participants 40 participants 40 participants 40 participants 40 participants 40 participants 20 participants 678 participants
24.3  (5.5) 26.2  (7.2) 25.5  (5.0) 24.1  (4.6) 26.5  (6.2) 25.1  (5.3) 25.1  (6.3) 24.3  (6.0) 23.5  (3.2) 23.4  (4.1) 23.5  (5.7) 23.5  (5.2) 24.7  (6.1) 23.6  (5.0) 24.9  (5.9) 22.7  (4.0) 22.9  (5.8) 23.5  (5.3) 24.3  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 39 participants 40 participants 40 participants 40 participants 39 participants 40 participants 20 participants 40 participants 40 participants 40 participants 40 participants 40 participants 40 participants 40 participants 40 participants 20 participants 678 participants
Female
40
 100.0%
40
 100.0%
39
 100.0%
40
 100.0%
40
 100.0%
40
 100.0%
39
 100.0%
40
 100.0%
20
 100.0%
40
 100.0%
40
 100.0%
40
 100.0%
40
 100.0%
40
 100.0%
40
 100.0%
40
 100.0%
40
 100.0%
20
 100.0%
678
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Group 1
Hide Description The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL as determined by ELISA at day 61 across cohorts 1 and 2 for potential use in pregnant women.
Time Frame Day 1 and Day 61
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on primary Per Protocol Set (PPS) - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 61; and had no major protocol violations as defined prior to analysis.
Arm/Group Title 5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 40 38 35 38 37 37 38 38 17
Measure Type: Number
Unit of Measure: percentage of subjects
Day 1 (Serogroup Ia;N=40,33,33,35,33,32,34,35,17) 38 30 30 29 30 38 35 20 18
Day 61 (Serogroup Ia) 98 97 91 95 97 95 87 84 18
Day 1 (Serogroup Ib; N=37,33,34,35,34,32,34,32,17) 24 12 18 17 26 16 24 9 18
Day 61 (Serogroup Ib;N=39,38,35,38,37,37,38,36,16) 82 95 83 84 78 86 84 64 19
Day 1 (Serogroup III;N=40,38,35,38,37,36,38,38,17) 18 13 11 13 16 28 16 18 12
Day 61 (SerogroupIII;N=40,37,35,38,36,37,37,37,17) 70 81 77 79 67 86 70 76 12
2.Primary Outcome
Title Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 61
Hide Description Serotype–specific (Ia, Ib & III) group B streptococcus (GBS) IgG antibody levels in healthy subjects for potential use in pregnant woman was assessed in terms of Geometric Mean Concentrations (GMCs) at Day 61 in cohorts 1 and 2.
Time Frame Day 1 and Day 61
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Primary PPS
Arm/Group Title 5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 40 38 35 38 37 37 38 38 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Day 1 (Serotype Ia; N=40,33,33,35,33,32,34,35,17)
0.62
(0.36 to 1.08)
0.51
(0.28 to 0.94)
0.38
(0.21 to 0.71)
0.45
(0.25 to 0.81)
0.48
(0.26 to 0.87)
0.57
(0.31 to 1.06)
0.54
(0.29 to 0.98)
0.37
(0.2 to 0.67)
0.25
(0.11 to 0.59)
Day 61 (Serotype Ia; N=40,38,35,38,37,37,38,37,17)
20
(9.42 to 41)
11
(5.41 to 24)
15
(7.08 to 34)
18
(8.34 to 37)
14
(6.54 to 30)
9.99
(4.67 to 21)
9.64
(4.55 to 20)
6.49
(3.03 to 14)
0.25
(0.083 to 0.78)
Day 1 (Serotype Ib; N=37,33,34,35,34,32,34,32,17 )
0.15
(0.089 to 0.25)
0.11
(0.065 to 0.19)
0.11
(0.064 to 0.19)
0.11
(0.062 to 0.18)
0.15
(0.088 to 0.26)
0.12
(0.068 to 0.21)
0.12
(0.072 to 0.21)
0.081
(0.046 to 0.14)
0.16
(0.072 to 0.34)
Day 61(Serotype Ib;N=39,38,35,38,37,37,38,36,16)
6.75
(3.21 to 14)
4.56
(2.15 to 9.69)
4.26
(1.95 to 9.34)
4.45
(2.09 to 9.44)
4.72
(2.2 to 10)
3.85
(1.79 to 8.24)
3.92
(1.85 to 8.32)
2.06
(0.95 to 4.46)
0.24
(0.075 to 0.76)
Day 1 (Serotype III; N=40,38,35,38,37,36,38,38,17)
0.13
(0.08 to 0.2)
0.089
(0.056 to 0.14)
0.087
(0.054 to 0.14)
0.077
(0.049 to 0.12)
0.099
(0.062 to 0.16)
0.15
(0.096 to 0.25)
0.09
(0.057 to 0.14)
0.12
(0.074 to 0.19)
0.1
(0.05 to 0.2)
Day 61(Serotype III; N=40,37,35,38,36,37,37,37,17)
3.27
(1.6 to 6.68)
3.23
(1.54 to 6.78)
2.31
(1.08 to 4.95)
2.35
(1.13 to 4.89)
1.49
(0.7 to 3.15)
4.3
(2.05 to 9.04)
1.4
(0.67 to 2.94)
3.28
(1.56 to 6.89)
0.1
(0.035 to 0.31)
3.Primary Outcome
Title Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype
Hide Description Geometric mean ratios (GMRs) relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels measured at Day 61 for subjects across cohorts 1 and 2.
Time Frame Day 61/Day 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Primary PPS.
Arm/Group Title 5 µg-1 Inj - No Adj 5 µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5 µg-1 Inj - Alum 5 µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 40 37 34 38 36 36 37 37 17
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
serotype Ia; N=40,33,32,35,33,32,34,35,17
32
(19 to 53)
28
(16 to 50)
37
(21 to 66)
45
(26 to 78)
36
(20 to 64)
23
(13 to 42)
25
(14 to 44)
19
(11 to 33)
1.01
(0.46 to 2.24)
Serotype Ib; N=37,33,33,35,34,32,34,31,16
47
(29 to 77)
46
(27 to 78)
39
(23 to 66)
47
(28 to 79)
38
(22 to 63)
32
(19 to 54)
33
(20 to 55)
23
(13 to 39)
1.55
(0.73 to 3.28)
Serotype III
26
(16 to 43)
36
(22 to 61)
26
(15 to 45)
30
(18 to 50)
15
(8.71 to 25)
30
(18 to 50)
16
(9.48 to 26)
30
(18 to 50)
1.13
(0.52 to 2.46)
4.Primary Outcome
Title Percentage of Subjects Achieving Specific Thresholds of Antibody Concentrations for Subjects in Enrollment Groups 1 & 2
Hide Description The percentage of subjects achieving a specific threshold of antibody concentrations of ≥ 0.5 µg/mL at day 361 across all the cohorts for potential use in non-pregnant women.
Time Frame Day 1 and Day 361
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Co-primary PPS - The subjects who received the vaccine correctly; provided evaluable serum samples at baseline and Day 361; and had no major protocol violations as defined prior to analysis
Arm/Group Title 5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1 5µg-1 Inj – MF59_H 5µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5µg-1 Inj – MF59_F 5µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 2
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 40 32 32 35 34 33 34 36 17 37 38 38 39 38 37 38 39 20
Measure Type: Number
Unit of Measure: percentage of subjects
Day 1 (Serogroup Ia) 38 28 28 29 35 39 35 22 18 30 29 16 28 29 38 21 31 20
Day 361 (Serogroup Ia) 85 78 88 86 86 92 79 75 14 78 82 76 95 69 92 76 90 20
Day 1 (Serogroup Ib) 24 13 15 17 26 15 24 9 18 24 15 6 26 23 19 6 11 24
Day 361 (Serogroup Ib) 95 92 91 97 92 100 100 89 46 92 100 87 97 95 97 100 100 22
Day 1 (Serogroup III) 18 14 12 13 16 30 16 18 12 14 11 5 8 14 14 11 8 0
Day 361 (Serogroup III) 85 84 82 95 76 95 87 89 20 86 95 92 100 87 100 89 92 6
5.Primary Outcome
Title Geometric Mean Concentrations of Serum Anti-GBS IgG Antibody Levels by Serotype at Day 361
Hide Description Serotype-specific (Ia, Ib & III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant woman was assessed in terms of GMCs at Day 361 across all cohorts.
Time Frame Day 1 and Day 361
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Co-Primary PPS
Arm/Group Title 5 µg-1 Inj - No Adj 5 µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5 µg-1 Inj - Alum 5 µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1 5 µg-1 Inj – MF59_H 5 µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5 µg-1 Inj – MF59_F 5 µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 2
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 40 37 34 38 38 37 38 39 17 37 38 38 39 39 37 38 39 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Day1(Serotype Ia)
0.62
(0.36 to 1.07)
0.45
(0.25 to 0.84)
0.36
(0.2 to 0.67)
0.45
(0.25 to 0.8)
0.53
(0.29 to 0.96)
0.62
(0.34 to 1.14)
0.54
(0.3 to 0.97)
0.37
(0.21 to 0.66)
0.25
(0.11 to 0.58)
0.54
(0.32 to 0.91)
0.43
(0.25 to 0.72)
0.27
(0.16 to 0.45)
0.36
(0.22 to 0.61)
0.44
(0.26 to 0.73)
0.46
(0.27 to 0.79)
0.36
(0.21 to 0.6)
0.45
(0.27 to 0.75)
0.34
(0.17 to 0.7)
Day361(Serotype Ia)
5.86
(2.93 to 12)
3.78
(1.85 to 7.72)
4
(1.9 to 8.41)
4.6
(2.25 to 9.38)
5.83
(2.86 to 12)
5.22
(2.56 to 11)
3.78
(1.87 to 7.65)
2.94
(1.43 to 6.05)
0.26
(0.08 to 0.81)
3.62
(1.84 to 7.13)
3.04
(1.56 to 5.93)
2.13
(1.09 to 4.15)
7.19
(3.72 to 14)
2.65
(1.37 to 5.12)
7.32
(3.72 to 14)
2.67
(1.36 to 5.24)
4.41
(2.28 to 8.52)
0.31
(0.12 to 0.77)
Day1(Serotype Ib)
0.15
(0.089 to 0.25)
0.12
(0.066 to 0.2)
0.099
(0.058 to 0.17)
0.11
(0.062 to 0.18)
0.15
(0.085 to 0.25)
0.12
(0.069 to 0.2)
0.12
(0.073 to 0.21)
0.079
(0.046 to 0.14)
0.16
(0.073 to 0.33)
0.12
(0.071 to 0.21)
0.1
(0.058 to 0.17)
0.07
(0.04 to 0.12)
0.11
(0.062 to 0.18)
0.15
(0.083 to 0.26)
0.11
(0.065 to 0.2)
0.077
(0.044 to 0.13)
0.09
(0.053 to 0.15)
0.1
(0.048 to 0.22)
Day361(Serotype Ib)
4.03
(2.38 to 6.83)
3.7
(2.15 to 6.36)
2.86
(1.62 to 5.03)
3.82
(2.22 to 6.58)
3.13
(1.82 to 5.38)
4.59
(2.67 to 7.89)
3.38
(1.98 to 5.77)
2.45
(1.41 to 4.24)
0.81
(0.33 to 2.03)
2.67
(1.53 to 4.66)
3.81
(2.19 to 6.61)
1.88
(1.08 to 3.27)
5.53
(3.21 to 9.54)
3.18
(1.85 to 5.48)
5.19
(2.97 to 9.08)
3.9
(2.23 to 6.82)
3.64
(2.11 to 6.27)
0.18
(0.079 to 0.39)
Day1(serotype III)
0.13
(0.08 to 0.2)
0.091
(0.057 to 0.15)
0.089
(0.055 to 0.15)
0.077
(0.049 to 0.12)
0.1
(0.064 to 0.16)
0.16
(0.1 to 0.26)
0.09
(0.057 to 0.14)
0.12
(0.074 to 0.19)
0.1
(0.05 to 0.2)
0.1
(0.066 to 0.17)
0.079
(0.05 to 0.13)
0.058
(0.037 to 0.092)
0.067
(0.042 to 0.11)
0.1
(0.066 to 0.16)
0.11
(0.067 to 0.17)
0.078
(0.049 to 0.12)
0.093
(0.059 to 0.15)
0.068
(0.036 to 0.13)
Day361(Serotype III)
3.05
(1.78 to 5.2)
2.71
(1.57 to 4.69)
2.45
(1.38 to 4.34)
2.78
(1.61 to 4.81)
1.77
(1.02 to 3.07)
4.48
(2.59 to 7.76)
1.77
(1.03 to 3.03)
3.46
(1.98 to 6.04)
0.13
(0.054 to 0.3)
2.33
(1.42 to 3.8)
2.67
(1.64 to 4.34)
2.06
(1.27 to 3.34)
4.5
(2.78 to 7.26)
2.62
(1.62 to 4.23)
4.99
(3.05 to 8.17)
3.07
(1.87 to 5.02)
3.51
(2.17 to 5.67)
0.076
(0.038 to 0.15)
6.Primary Outcome
Title Geometric Mean Ratios of Serum Group B Streptococcus IgG Antibody Levels By Serotype at Day 361
Hide Description GMRs relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels in healthy subjects for potential use in non-pregnant women, measured at Day 361 across all cohorts.
Time Frame Day 1 and day 361
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Co-Primary PPS.
Arm/Group Title 5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1 5µg-1 Inj – MF59_H 5µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5µg-1 Inj – MF59_F 5µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 2
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 39 37 33 37 37 36 38 36 14 37 38 38 39 38 37 37 39 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
Day361/Day1(Serotype Ia)
9.13
(5.74 to 15)
10
(6.09 to 17)
9.89
(5.87 to 17)
15
(8.9 to 24)
14
(8.3 to 23)
11
(6.58 to 18)
8.93
(5.43 to 15)
9.54
(5.8 to 16)
0.93
(0.43 to 2.01)
6.75
(4.44 to 10)
7.15
(4.73 to 11)
7.99
(5.29 to 12)
20
(13 to 30)
6.17
(4.09 to 9.33)
16
(10 to 24)
7.29
(4.8 to 11)
9.83
(6.54 to 15)
0.9
(0.51 to 1.59)
Day361/Day1(Serotype Ib)
28
(19 to 40)
37
(26 to 55)
26
(18 to 38)
38
(26 to 55)
23
(16 to 34)
38
(26 to 55)
27
(19 to 39)
30
(21 to 44)
3.97
(2.19 to 7.19)
23
(16 to 33)
37
(26 to 53)
27
(18 to 39)
54
(38 to 76)
26
(18 to 37)
45
(31 to 66)
49
(34 to 71)
35
(25 to 50)
1.75
(1.04 to 2.94)
Day361/Day1(Serotype III)
24
(16 to 35)
30
(20 to 45)
27
(17 to 41)
35
(23 to 53)
17
(12 to 26)
30
(20 to 45)
20
(13 to 29)
31
(20 to 47)
1.4
(0.72 to 2.72)
22
(15 to 33)
35
(23 to 53)
35
(24 to 53)
65
(44 to 97)
26
(18 to 40)
45
(30 to 68)
38
(26 to 58)
38
(26 to 56)
1.24
(0.7 to 2.21)
7.Secondary Outcome
Title Number of Participants Reporting Solicited Adverse Events (AEs) After Receiving the GBS Trivalent Vaccine in Enrollment Group 1
Hide Description Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving trivalent GBS vaccine from day 1 to day 7 for subjects across cohorts 1 and 2.
Time Frame Day 1 to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Solicited Safety Set - All subjects in the Exposed Set who provided data on post vaccination local or systemic AEs or other signs of reactogenicity.
Arm/Group Title 5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 40 40 39 40 40 40 39 39 19
Measure Type: Number
Unit of Measure: participants
Any Local 30 32 31 35 39 37 38 39 8
Inj site Induration 9 13 6 9 12 16 16 15 3
Inj site swelling 5 5 5 5 7 8 16 8 2
Ecchymosis 5 3 7 2 5 4 0 2 0
Redness 8 8 9 8 9 12 15 14 3
Warmth 10 11 9 13 11 14 11 16 1
Inj site Pain 28 28 31 34 39 37 38 39 7
Any Systemic 25 21 22 28 27 20 29 21 11
Chills 3 2 5 2 3 1 4 4 3
Nausea 6 5 8 5 7 6 5 4 1
Malaise 7 6 11 11 7 9 12 9 2
Myalgia 6 1 7 8 3 5 8 6 2
Arthralgia 2 1 3 2 3 3 3 6 0
Headache 16 15 13 18 19 17 19 11 7
Fatigue 18 9 18 21 19 13 17 13 6
Rash 1 0 0 1 1 1 0 0 0
Fever (≥ 38C) 2 0 1 1 1 2 0 3 0
8.Secondary Outcome
Title Number of Participants Reporting Solicited AEs After Receiving the GBS Trivalent Vaccine in Enrollment Group 2
Hide Description Safety was assessed in terms of number of participants reporting solicited local and systemic adverse events after receiving GBS vaccine from day 1 to day 7 for subjects in cohorts 3 and 4.
Time Frame Day 1 to Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Solicited Safety Set
Arm/Group Title 5µg-1 Inj – MF59_H 5µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5µg-1 Inj – MF59_F 5µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 2
Hide Arm/Group Description:
Subjects received single active vaccine injection adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 40 40 40 40 40 40 40 40 20
Measure Type: Number
Unit of Measure: participants
Any Local 33 37 36 40 37 38 39 39 8
Inj site Induration 5 12 7 12 8 9 14 14 3
Inj site swelling 2 9 7 11 8 10 7 13 2
Ecchymosis 2 4 4 2 5 4 5 5 2
Redness 3 11 8 8 6 8 7 17 4
Warmth 6 17 14 21 12 14 17 21 6
Inj site Pain 32 35 35 40 37 37 39 39 5
Any Systemic 23 28 23 31 28 31 30 34 13
Chills 2 5 7 9 7 7 5 16 5
Nausea 8 8 6 10 5 10 8 13 5
Malaise 11 17 13 13 17 15 17 20 6
Myalgia 6 11 8 10 14 10 7 17 2
Arthralgia 1 3 5 3 3 4 4 7 1
Headache 13 19 14 23 14 23 22 30 10
Fatigue 17 18 18 21 25 20 20 22 9
Rash 0 1 2 1 2 1 3 1 0
Fever (≥ 38C) 0 1 2 1 5 1 4 6 0
9.Secondary Outcome
Title Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 1
Hide Description Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 1 and 2.
Time Frame Day 1 through Day 721
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on unsolicited safety set - All subjects in the Exposed Set who provided information about postvaccination unsolicited AEs.
Arm/Group Title 5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 40 40 39 40 40 40 39 39 19
Measure Type: Number
Unit of Measure: participants
Any AEs 32 33 31 27 32 30 33 32 16
At least possibly related AEs 8 11 11 11 4 6 7 5 0
Serious AEs 1 1 0 2 6 2 2 0 2
Medically attended AEs 25 24 23 18 26 24 28 27 11
10.Secondary Outcome
Title Number of Participants Reporting Unsolicited AE After Receiving GBS Trivalent Vaccine in Enrollment Group 2
Hide Description Safety was assessed in terms of number of participants with unsolicited AEs after receiving GBS trivalent vaccine, reported from day 1 to day 721 across subjects in cohorts 3 and 4.
Time Frame Day 1 through Day 721
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on Unsolicited Safety Set.
Arm/Group Title 5µg-1 Inj – MF59_H 5µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5µg-1 Inj – MF59_F 5µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 2
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 40 40 40 40 40 40 40 40 20
Measure Type: Number
Unit of Measure: participants
Any AEs 30 34 36 38 29 35 34 32 16
At least possibly related AEs 0 6 5 6 4 2 9 13 1
Serious AEs 2 2 0 3 3 2 6 2 1
Medically attended AEs 27 26 26 27 22 28 27 26 10
11.Secondary Outcome
Title Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype for Subjects in Enrollment Group 1
Hide Description The persistence of Serotype–specific (Ia, Ib & III) GBS IgG antibody response was assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohorts 1 and 2.
Time Frame Day 1 and Day 721
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on secondary persistence PPS - All the subjects who provided all serum sample results from Baseline (prior to vaccination) through Day 721 within protocol required windows.
Arm/Group Title 5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 36 32 29 31 29 27 33 31 9
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Day 1 (serotype Ia)
0.63
(0.35 to 1.11)
0.45
(0.25 to 0.83)
0.39
(0.21 to 0.75)
0.34
(0.19 to 0.64)
0.55
(0.29 to 1.04)
0.49
(0.25 to 0.95)
0.56
(0.31 to 1.01)
0.34
(0.18 to 0.63)
0.37
(0.12 to 1.16)
Day 721 (Serotype Ia)
4.69
(2.23 to 9.89)
3.48
(1.58 to 7.67)
3.11
(1.36 to 7.14)
3.18
(1.42 to 7.09)
5.1
(2.23 to 12)
3.01
(1.27 to 7.11)
3.69
(1.69 to 8.03)
2.17
(0.97 to 4.85)
0.3
(0.068 to 1.34)
Day 1(Serotype Ib;N=32,30,28,32,29,28,28,27,6)
0.16
(0.089 to 0.28)
0.11
(0.061 to 0.2)
0.094
(0.051 to 0.17)
0.11
(0.063 to 0.2)
0.18
(0.1 to 0.33)
0.13
(0.069 to 0.23)
0.14
(0.078 to 0.27)
0.085
(0.045 to 0.16)
0.88
(0.23 to 3.29)
Day 721(Serotype Ib;N=32,30,28,32,29,28,28,27,6)
2.92
(1.51 to 5.64)
2.81
(1.42 to 5.55)
1.71
(0.85 to 3.46)
2.64
(1.37 to 5.1)
2.32
(1.16 to 4.64)
2.96
(1.47 to 5.99)
2.55
(1.26 to 5.15)
1.45
(0.71 to 2.97)
1.02
(0.22 to 4.68)
Day 1(Serotype III;N=34,33,28,34,30,30,34,31,6)
0.14
(0.083 to 0.23)
0.097
(0.058 to 0.16)
0.094
(0.053 to 0.17)
0.079
(0.047 to 0.13)
0.12
(0.069 to 0.21)
0.16
(0.095 to 0.28)
0.095
(0.057 to 0.16)
0.12
(0.07 to 0.21)
0.071
(0.021 to 0.24)
Day 721(Serotype III;N=34,33,28,34,30,30,34,31,6)
3.19
(1.77 to 5.77)
1.89
(1.04 to 3.45)
1.7
(0.89 to 3.27)
2.16
(1.2 to 3.91)
1.26
(0.67 to 2.36)
3.87
(2.06 to 7.26)
1.44
(0.8 to 2.6)
2.68
(1.44 to 4.99)
0.054
(0.013 to 0.22)
12.Secondary Outcome
Title Persistence of Antibody Response in Terms of Geometric Mean Concentrations by Serotype in Subjects in Enrollment Group 2
Hide Description The persistence of Serotype-specific (Ia, Ib & III) GBS IgG antibody response assessed by comparing ELISA responses in terms of GMCs at day 721 after the first injection for subjects enrolled in cohort 3 and 4.
Time Frame Day 1 and Day 721
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on secondary persistence PPS.
Arm/Group Title 5µg-1 Inj – MF59_H 5µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5µg-1 Inj – MF59_F 5µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 2
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 35 34 34 34 36 33 37 36 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Day 1 (serotype Ia)
0.47
(0.27 to 0.81)
0.48
(0.27 to 0.83)
0.28
(0.16 to 0.49)
0.29
(0.17 to 0.51)
0.46
(0.27 to 0.79)
0.53
(0.3 to 0.93)
0.37
(0.21 to 0.62)
0.49
(0.28 to 0.84)
0.37
(0.17 to 0.79)
Day 721 (Serotype Ia)
1.86
(0.9 to 3.83)
1.97
(0.95 to 4.11)
1.73
(0.83 to 3.6)
3.09
(1.49 to 6.44)
1.66
(0.82 to 3.39)
5.06
(2.4 to 11)
1.72
(0.85 to 3.47)
3.32
(1.63 to 6.77)
0.33
(0.12 to 0.9)
Day 1(Serotype Ib;N=32,28,29,29,28,24,30,33,9)
0.13
(0.074 to 0.23)
0.092
(0.051 to 0.17)
0.072
(0.04 to 0.13)
0.1
(0.058 to 0.19)
0.15
(0.08 to 0.27)
0.15
(0.077 to 0.28)
0.08
(0.045 to 0.14)
0.094
(0.054 to 0.16)
0.16
(0.055 to 0.46)
Day 721(Serotype Ib;N=32,28,29,29,28,24,30,33,9)
1.7
(0.9 to 3.22)
1.72
(0.87 to 3.41)
1.16
(0.59 to 2.27)
2.99
(1.53 to 5.86)
2.5
(1.26 to 4.96)
4.23
(2.02 to 8.84)
2.47
(1.28 to 4.79)
1.93
(1.03 to 3.61)
0.21
(0.063 to 0.7)
Day 1(Serotype III;N=34,32,34,32,33,31,36,33,14)
0.11
(0.068 to 0.18)
0.082
(0.049 to 0.14)
0.061
(0.037 to 0.1)
0.071
(0.043 to 0.12)
0.09
(0.054 to 0.15)
0.12
(0.069 to 0.2)
0.077
(0.048 to 0.12)
0.1
(0.06 to 0.17)
0.061
(0.028 to 0.13)
Day721(Serotype III;N=34,32,34,32,33,31,36,33,14)
1.72
(1 to 2.96)
1.59
(0.91 to 2.79)
1.29
(0.75 to 2.23)
2.48
(1.42 to 4.33)
2.04
(1.17 to 3.53)
3.18
(1.8 to 5.61)
1.78
(1.05 to 3.02)
2.05
(1.18 to 3.56)
0.075
(0.032 to 0.17)
13.Secondary Outcome
Title Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 1
Hide Description GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across all cohorts 1 and 2.
Time Frame Day 1 and Day 721
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on secondary persistence PPS
Arm/Group Title 5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 36 32 29 31 29 27 33 31 9
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
Day 721/Day 1(Serotype Ia)
7.5
(4.51 to 12)
7.67
(4.47 to 13)
7.89
(4.48 to 14)
9.24
(5.34 to 16)
9.25
(5.25 to 16)
6.15
(3.42 to 11)
6.64
(3.9 to 11)
6.35
(3.67 to 11)
0.82
(0.3 to 2.26)
Day 721/ Day 1 (Serotype Ib)
19
(12 to 28)
26
(17 to 40)
18
(12 to 29)
24
(15 to 36)
13
(8.16 to 20)
23
(15 to 37)
18
(11 to 28)
17
(11 to 27)
1.17
(0.44 to 3.1)
Day 721/ Day 1 (Serotype III)
23
(15 to 35)
19
(13 to 30)
18
(11 to 29)
27
(18 to 41)
11
(6.81 to 16)
24
(15 to 37)
15
(10 to 23)
22
(14 to 35)
0.76
(0.28 to 2.06)
14.Secondary Outcome
Title Geometric Mean Ratios of Serum GBS IgG Antibody Levels By Serotype for Subjects in Enrollment Group 2
Hide Description GMR was calculated at Day 721 relative to baseline (Day 1) of serotype-specific (Ia, Ib, III) GBS IgG antibody levels across cohorts 3 and 4.
Time Frame Day 1 and Day 721
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on secondary persistence PPS.
Arm/Group Title 5µg-1 Inj – MF59_H 5µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5µg-1 Inj – MF59_F 5µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 2
Hide Arm/Group Description:
Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
Subjects received two injections of placebo administered 1 month apart
Overall Number of Participants Analyzed 35 34 34 34 36 33 37 36 18
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
Day 721/Day 1 (Serotype Ia)
3.98
(2.55 to 6.2)
4.14
(2.64 to 6.5)
6.12
(3.9 to 9.6)
11
(6.74 to 17)
3.61
(2.33 to 5.6)
9.61
(6.09 to 15)
4.7
(3.05 to 7.23)
6.8
(4.39 to 11)
0.89
(0.48 to 1.65)
Day 721/Day 1 (Serotype Ib)
13
(8.76 to 20)
19
(12 to 29)
16
(10 to 24)
29
(19 to 44)
17
(11 to 26)
29
(18 to 45)
31
(20 to 47)
20
(14 to 30)
1.31
(0.61 to 2.8)
Day 721/Day 1 (Serotype III)
16
(10 to 24)
19
(12 to 30)
21
(14 to 33)
35
(22 to 54)
23
(15 to 35)
27
(17 to 43)
23
(15 to 35)
21
(13 to 32)
1.22
(0.62 to 2.4)
<
Time Frame Day 1 through Day 721
Adverse Event Reporting Description

All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.

Safety analysis was done on As treated set.

 
Arm/Group Title 5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1 5µg-1 Inj – MF59_H 5µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5µg-1 Inj – MF59_F 5µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 2
Hide Arm/Group Description Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart Subjects received two injections of placebo administered 1 month apart Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart Subjects received two injections of placebo administered 1 month apart
All-Cause Mortality
5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1 5µg-1 Inj – MF59_H 5µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5µg-1 Inj – MF59_F 5µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 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 (%) 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
5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1 5µg-1 Inj – MF59_H 5µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5µg-1 Inj – MF59_F 5µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      1/40 (2.50%)      0/39 (0.00%)      2/40 (5.00%)      6/40 (15.00%)      2/40 (5.00%)      2/39 (5.13%)      0/40 (0.00%)      2/20 (10.00%)      2/40 (5.00%)      2/40 (5.00%)      0/40 (0.00%)      3/40 (7.50%)      3/40 (7.50%)      2/40 (5.00%)      6/40 (15.00%)      2/40 (5.00%)      1/20 (5.00%)    
Cardiac disorders                                     
Mitral Valve Incompetence * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Ear and labyrinth disorders                                     
Meniere's Disease * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/20 (0.00%) 
Gastrointestinal disorders                                     
Constipation * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Abdominal Pain Upper * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Food Poisoning * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Vomiting * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
General disorders                                     
Hernia * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/20 (0.00%) 
Hepatobiliary disorders                                     
Biliary Colic * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Cholecystitis * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/20 (0.00%) 
Infections and infestations                                     
Appendicitis * 1  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%)  2/40 (5.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/20 (0.00%) 
Lyme Disease * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Pharyngotonsillitis * 1  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Pilonidal Cyst * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Pneumonia * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Pyelonephritis * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Tonsillitis Bacterial * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Typhoid Fever * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/20 (0.00%) 
Injury, poisoning and procedural complications                                     
Ankle Fracture * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Ligament Rupture * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Post Lumbar Puncture Syndrome * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Tendon Injury * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Decompression Sickness * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/20 (5.00%) 
Rib Fracture * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Ulna Fracture * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Metabolism and nutrition disorders                                     
Overweight * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  1/40 (2.50%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders                                     
Intervertebral Disc Degeneration * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/20 (5.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Muscular Weakness * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                                     
Malignant Melanoma * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/20 (0.00%) 
Nervous system disorders                                     
Migraine * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Headache * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Pregnancy, puerperium and perinatal conditions                                     
Abortion Spontaneous * 1  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/20 (5.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Psychiatric disorders                                     
Eating Disorder * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Depression * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  1/40 (2.50%)  0/40 (0.00%)  0/20 (0.00%) 
Renal and urinary disorders                                     
Renal Colic * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Nephritis * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Reproductive system and breast disorders                                     
Cervical Dysplasia * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/20 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
5µg-1 Inj - No Adj 5µg-2 Inj - No Adj 20 µg-1 Inj - No Adj 20 µg-2 Inj - No Adj 5µg-1 Inj - Alum 5µg-2 Inj - Alum 20 µg-1 Inj - Alum 20 µg-2 Inj- Alum Placebo - Group 1 5µg-1 Inj – MF59_H 5µg-2 Inj – MF59_H 20 µg-1 Inj – MF59_H 20 µg-2 Inj – MF59_H 5µg-1 Inj – MF59_F 5µg-2 Inj – MF59_F 20 µg-1 Inj – MF59_F 20 µg-2 Inj- MF59_F Placebo – Group 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/40 (92.50%)      38/40 (95.00%)      38/39 (97.44%)      39/40 (97.50%)      39/40 (97.50%)      39/40 (97.50%)      39/39 (100.00%)      39/39 (100.00%)      18/19 (94.74%)      38/40 (95.00%)      37/40 (92.50%)      40/40 (100.00%)      40/40 (100.00%)      39/40 (97.50%)      39/40 (97.50%)      40/40 (100.00%)      40/40 (100.00%)      18/20 (90.00%)    
Blood and lymphatic system disorders                                     
Lymphadenopathy * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/19 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  1/40 (2.50%)  3/40 (7.50%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  1/40 (2.50%)  0/20 (0.00%) 
Ear and labyrinth disorders                                     
Middle Ear Effusion * 1  0/40 (0.00%)  0 0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/19 (5.26%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Endocrine disorders                                     
Hypothyroidism * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/19 (5.26%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Eye disorders                                     
Eyelid Edema * 1  1/40 (2.50%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/19 (5.26%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Iritis * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/19 (5.26%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Gastrointestinal disorders                                     
Apthous Stomatitis * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  1/39 (2.56%)  1/19 (5.26%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Diarrhea * 1  1/40 (2.50%)  2/40 (5.00%)  1/39 (2.56%)  1/40 (2.50%)  1/40 (2.50%)  0/40 (0.00%)  3/39 (7.69%)  2/39 (5.13%)  1/19 (5.26%)  3/40 (7.50%)  5/40 (12.50%)  1/40 (2.50%)  3/40 (7.50%)  1/40 (2.50%)  1/40 (2.50%)  3/40 (7.50%)  2/40 (5.00%)  0/20 (0.00%) 
Enteritis * 1  1/40 (2.50%)  1/40 (2.50%)  1/39 (2.56%)  0/40 (0.00%)  0/40 (0.00%)  3/40 (7.50%)  0/39 (0.00%)  0/39 (0.00%)  0/19 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Gastrointestinal Disorder * 1  1/40 (2.50%)  3/40 (7.50%)  1/39 (2.56%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  1/39 (2.56%)  0/39 (0.00%)  0/19 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Nausea  1  6/40 (15.00%)  6/40 (15.00%)  9/39 (23.08%)  7/40 (17.50%)  7/40 (17.50%)  8/40 (20.00%)  6/39 (15.38%)  4/39 (10.26%)  1/19 (5.26%)  10/40 (25.00%)  8/40 (20.00%)  7/40 (17.50%)  11/40 (27.50%)  5/40 (12.50%)  10/40 (25.00%)  10/40 (25.00%)  13/40 (32.50%)  5/20 (25.00%) 
Toothache * 1  1/40 (2.50%)  1/40 (2.50%)  0/39 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  3/40 (7.50%)  1/39 (2.56%)  1/39 (2.56%)  0/19 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Abdominal Pain * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/19 (0.00%)  1/40 (2.50%)  3/40 (7.50%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  1/40 (2.50%)  4/40 (10.00%)  2/40 (5.00%)  0/20 (0.00%) 
Abdominal Pain Upper * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/19 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  3/40 (7.50%)  1/40 (2.50%)  0/40 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  1/20 (5.00%) 
Gastritis * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/19 (0.00%)  1/40 (2.50%)  0/40 (0.00%)  2/40 (5.00%)  3/40 (7.50%)  1/40 (2.50%)  1/40 (2.50%)  1/40 (2.50%)  1/40 (2.50%)  1/20 (5.00%) 
General disorders                                     
Chills  1  3/40 (7.50%)  2/40 (5.00%)  5/39 (12.82%)  2/40 (5.00%)  3/40 (7.50%)  1/40 (2.50%)  4/39 (10.26%)  4/39 (10.26%)  3/19 (15.79%)  2/40 (5.00%)  5/40 (12.50%)  7/40 (17.50%)  9/40 (22.50%)  7/40 (17.50%)  7/40 (17.50%)  5/40 (12.50%)  16/40 (40.00%)  5/20 (25.00%) 
Fatigue  1  19/40 (47.50%)  11/40 (27.50%)  18/39 (46.15%)  21/40 (52.50%)  19/40 (47.50%)  13/40 (32.50%)  18/39 (46.15%)  14/39 (35.90%)  7/19 (36.84%)  17/40 (42.50%)  18/40 (45.00%)  19/40 (47.50%)  22/40 (55.00%)  26/40 (65.00%)  20/40 (50.00%)  20/40 (50.00%)  22/40 (55.00%)  9/20 (45.00%) 
Influenza Like Illness * 1  3/40 (7.50%)  1/40 (2.50%)  2/39 (5.13%)  1/40 (2.50%)  5/40 (12.50%)  2/40 (5.00%)  2/39 (5.13%)  4/39 (10.26%)  1/19 (5.26%)  7/40 (17.50%)  6/40 (15.00%)  4/40 (10.00%)  7/40 (17.50%)  3/40 (7.50%)  6/40 (15.00%)  5/40 (12.50%)  6/40 (15.00%)  1/20 (5.00%) 
Injection Site Erythema * 1  8/40 (20.00%)  8/40 (20.00%)  9/39 (23.08%)  8/40 (20.00%)  9/40 (22.50%)  12/40 (30.00%)  15/39 (38.46%)  15/39 (38.46%)  3/19 (15.79%)  3/40 (7.50%)  11/40 (27.50%)  8/40 (20.00%)  8/40 (20.00%)  6/40 (15.00%)  8/40 (20.00%)  7/40 (17.50%)  17/40 (42.50%)  4/20 (20.00%) 
Injection Site Hemorrhage * 1  5/40 (12.50%)  3/40 (7.50%)  7/39 (17.95%)  2/40 (5.00%)  5/40 (12.50%)  4/40 (10.00%)  0/39 (0.00%)  2/39 (5.13%)  0/19 (0.00%)  2/40 (5.00%)  5/40 (12.50%)  4/40 (10.00%)  2/40 (5.00%)  5/40 (12.50%)  4/40 (10.00%)  5/40 (12.50%)  5/40 (12.50%)  2/20 (10.00%) 
Injection Site Induration  1  9/40 (22.50%)  13/40 (32.50%)  7/39 (17.95%)  9/40 (22.50%)  12/40 (30.00%)  16/40 (40.00%)  16/39 (41.03%)  16/39 (41.03%)  3/19 (15.79%)  5/40 (12.50%)  12/40 (30.00%)  7/40 (17.50%)  12/40 (30.00%)  8/40 (20.00%)  9/40 (22.50%)  14/40 (35.00%)  14/40 (35.00%)  3/20 (15.00%) 
Injection Site Movement Impairment * 1  2/40 (5.00%)  1/40 (2.50%)  1/39 (2.56%)  3/40 (7.50%)  1/40 (2.50%)  0/40 (0.00%)  1/39 (2.56%)  2/39 (5.13%)  0/19 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Injection Site Pain  1  28/40 (70.00%)  28/40 (70.00%)  31/39 (79.49%)  35/40 (87.50%)  39/40 (97.50%)  37/40 (92.50%)  38/39 (97.44%)  39/39 (100.00%)  7/19 (36.84%)  32/40 (80.00%)  35/40 (87.50%)  35/40 (87.50%)  40/40 (100.00%)  37/40 (92.50%)  37/40 (92.50%)  39/40 (97.50%)  39/40 (97.50%)  5/20 (25.00%) 
Injection Site Swelling  1  6/40 (15.00%)  6/40 (15.00%)  5/39 (12.82%)  5/40 (12.50%)  7/40 (17.50%)  8/40 (20.00%)  16/39 (41.03%)  8/39 (20.51%)  2/19 (10.53%)  2/40 (5.00%)  9/40 (22.50%)  7/40 (17.50%)  11/40 (27.50%)  8/40 (20.00%)  10/40 (25.00%)  7/40 (17.50%)  13/40 (32.50%)  2/20 (10.00%) 
Injection Site Warmth  1  11/40 (27.50%)  11/40 (27.50%)  9/39 (23.08%)  13/40 (32.50%)  11/40 (27.50%)  14/40 (35.00%)  11/39 (28.21%)  16/39 (41.03%)  1/19 (5.26%)  6/40 (15.00%)  17/40 (42.50%)  14/40 (35.00%)  21/40 (52.50%)  12/40 (30.00%)  14/40 (35.00%)  17/40 (42.50%)  21/40 (52.50%)  6/20 (30.00%) 
Malaise  1  8/40 (20.00%)  6/40 (15.00%)  11/39 (28.21%)  11/40 (27.50%)  8/40 (20.00%)  9/40 (22.50%)  12/39 (30.77%)  9/39 (23.08%)  2/19 (10.53%)  11/40 (27.50%)  17/40 (42.50%)  13/40 (32.50%)  14/40 (35.00%)  17/40 (42.50%)  15/40 (37.50%)  17/40 (42.50%)  20/40 (50.00%)  6/20 (30.00%) 
Pyrexia * 1  2/40 (5.00%)  0/40 (0.00%)  4/39 (10.26%)  1/40 (2.50%)  2/40 (5.00%)  3/40 (7.50%)  3/39 (7.69%)  3/39 (7.69%)  0/19 (0.00%)  0/40 (0.00%)  3/40 (7.50%)  3/40 (7.50%)  2/40 (5.00%)  6/40 (15.00%)  2/40 (5.00%)  6/40 (15.00%)  10/40 (25.00%)  0/20 (0.00%) 
Immune system disorders                                     
Allergy To Arthropod Bite * 1  1/40 (2.50%)  1/40 (2.50%)  0/39 (0.00%)  0/40 (0.00%)  3/40 (7.50%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  0/19 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Infections and infestations                                     
Bronchitis * 1  4/40 (10.00%)  0/40 (0.00%)  1/39 (2.56%)  0/40 (0.00%)  1/40 (2.50%)  1/40 (2.50%)  1/39 (2.56%)  1/39 (2.56%)  0/19 (0.00%)  3/40 (7.50%)  1/40 (2.50%)  0/40 (0.00%)  2/40 (5.00%)  0/40 (0.00%)  2/40 (5.00%)  2/40 (5.00%)  1/40 (2.50%)  1/20 (5.00%) 
Chlamydial Infection * 1  0/40 (0.00%)  0/40 (0.00%)  2/39 (5.13%)  1/40 (2.50%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/19 (5.26%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Coxsackie Viral Infection * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/19 (5.26%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Cystitis * 1  2/40 (5.00%)  3/40 (7.50%)  0/39 (0.00%)  4/40 (10.00%)  0/40 (0.00%)  3/40 (7.50%)  1/39 (2.56%)  2/39 (5.13%)  1/19 (5.26%)  2/40 (5.00%)  3/40 (7.50%)  2/40 (5.00%)  1/40 (2.50%)  3/40 (7.50%)  2/40 (5.00%)  0/40 (0.00%)  2/40 (5.00%)  2/20 (10.00%) 
Cytomegalovirus Infection * 1  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/39 (0.00%)  0/39 (0.00%)  1/19 (5.26%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  0/20 (0.00%) 
Ear Infection * 1  0/40 (0.00%)  1/40 (2.50%)  0/39 (0.00%)  0/40 (0.00%)  0/40 (0.00%)  3/40 (7.50%)  0/39 (0.00%)  1/39 (2.56%)  0/19 (0.00%)  0/40 (0.00%)  0/40 (0.00%)