Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT01193920
Collaborator
(none)
380
1
6
26
14.6
Study Details
Study Description
Brief Summary
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
380 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa
Study Start Date
:
Oct 1, 2010
Actual Primary Completion Date
:
Dec 1, 2011
Actual Study Completion Date
:
Dec 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg Non-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum. |
Biological: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
|
| Placebo Comparator: 2: Placebo - Sterile saline Non-Pregnant Women who received two injection of saline solution. |
Other: Saline solution
Subjects received two injection of saline solution.
|
| Experimental: 3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. |
Biological: Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
|
| Experimental: 4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg Pregnant Women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. |
Biological: Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg
Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
|
| Experimental: 5: GBS Trivalent Vaccine - 5/5/5 µg Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine. |
Biological: Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
|
| Placebo Comparator: 6: Placebo - Sterile saline Pregnant Women who received one injection of saline solution. |
Other: saline solution
Subjects received one injection of saline solution.
|
Outcome Measures
Primary Outcome Measures
- The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. [Day 61, one month after the second vaccination]
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
- Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. [Day 61, one month after the second vaccination]
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
- The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. [Day of delivery]
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
- Antibody GMC in Maternal Subjects at Day of Delivery [Day of delivery]
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.
Secondary Outcome Measures
- The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. [Day 31, one month after vaccination]
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
- Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination [day 31]
Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.
- The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. [Day 361, one year after the first vaccination]
The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.
- Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination [Day 361, one year after the first vaccination]
Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.
- Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events [Day 61]
Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.
- Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events [From day 1 to one year after delivery]
Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.
- Antibody GMC Per Serotype at Different Time Points in Infants [Day 4, day 43 and day 91 after birth]
Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.
- Number of Infants Reporting Serious Adverse Events [one year after birth]
Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.
-
Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)
Exclusion Criteria:
-
Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive
-
Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chris Hani Baragwanath Hospital | Chris Hani Rd, Soweto | Johannesburg | South Africa |
Sponsors and Collaborators
- Novartis Vaccines
Investigators
- Study Chair: Novartis Vaccines and Diagnostics, Novartis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT01193920
Other Study ID Numbers:
- V98_08
- MCC Reference n° 20100601
First Posted:
Sep 2, 2010
Last Update Posted:
Aug 22, 2014
Last Verified:
Aug 1, 2014
Keywords provided by Novartis Vaccines
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non-pregnant/Placebo | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo | Infants 0.5/0.5/0.5 μg | Infants 2.5/2.5/2.5 μg | Infants 5/5/5 μg | Infants / Placebo |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum | Non-pregnant women received two injections of saline solution | Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of saline solution | Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received saline solution |
| Period Title: Overall Study | ||||||||||
| STARTED | 40 | 20 | 80 | 80 | 80 | 80 | 80 | 80 | 76 | 81 |
| COMPLETED | 37 | 20 | 74 | 76 | 74 | 76 | 74 | 76 | 71 | 74 |
| NOT COMPLETED | 3 | 0 | 6 | 4 | 6 | 4 | 6 | 4 | 5 | 7 |
Baseline Characteristics
| Arm/Group Title | Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non-pregnant/Placebo | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo | Infants 0.5/0.5/0.5 μg | Infants 2.5/2.5/2.5 μg | Infants 5/5/5 μg | Infants / Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum | Non-pregnant women received two injections of saline solution | Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of saline solution | Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of saline solution | Total of all reporting groups |
| Overall Participants | 40 | 20 | 80 | 80 | 80 | 80 | 80 | 80 | 76 | 81 | 697 |
| Age, Customized (years) [Mean (Standard Deviation) ] | |||||||||||
| Non pregnant subjects |
28.6
(5.0)
|
29.4
(5.1)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
28.8
(5.0)
|
| Maternal subjects |
NA
(NA)
|
NA
(NA)
|
25.3
(5.2)
|
25.3
(5.2)
|
24.2
(4.7)
|
25.7
(5.4)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
25.1
(5.1)
|
| Age, Customized (days) [Mean (Standard Deviation) ] | |||||||||||
| Mean (Standard Deviation) [days] |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
3.0
(3.3)
|
4.0
(7.8)
|
5.5
(16.9)
|
3.5
(8.8)
|
4.0
(10.3)
|
| Sex: Female, Male (Count of Participants) | |||||||||||
| Female |
40
100%
|
20
100%
|
80
100%
|
80
100%
|
80
100%
|
80
100%
|
45
56.3%
|
38
47.5%
|
33
43.4%
|
48
59.3%
|
544
78%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
35
43.8%
|
42
52.5%
|
43
56.6%
|
33
40.7%
|
153
22%
|
| Region of Enrollment (participants) [Number] | |||||||||||
| South Africa |
40
100%
|
20
100%
|
80
100%
|
80
100%
|
80
100%
|
80
100%
|
80
100%
|
80
100%
|
76
100%
|
81
100%
|
697
100%
|
Outcome Measures
| Title | The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. |
|---|---|
| Description | The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL. |
| Time Frame | Day 61, one month after the second vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS) - primary, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at Day 1 (prior to vaccination) and Day 61 |
| Arm/Group Title | Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non-pregnant/Placebo |
|---|---|---|
| Arm/Group Description | Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum | Non-pregnant women received two injections of saline solution |
| Measure Participants | 35 | 19 |
| Serotype Ia >=1 μg/mL (N=34, 19) |
91
|
37
|
| Serotype Ia >=2 μg/mL (N=34, 19) |
91
|
32
|
| Serotype Ia >=3 μg/mL (N=34, 19) |
88
|
26
|
| Serotype Ia >=5 μg/mL (N=34, 19) |
79
|
16
|
| Serotype Ia >=8 μg/mL (N=34, 19) |
76
|
16
|
| Serotype Ib >=1 μg/mL (N=33, 17) |
73
|
24
|
| Serotype Ib >=2 μg/mL (N=33, 17) |
67
|
12
|
| Serotype Ib >=3 μg/mL (N=33, 17) |
64
|
6
|
| Serotype Ib >=5 μg/mL (N=33, 17) |
42
|
6
|
| Serotype Ib >=8 μg/mL (N=33, 17) |
39
|
6
|
| Serotype III >=1 μg/mL |
89
|
37
|
| Serotype III >=2 μg/mL |
69
|
21
|
| Serotype III >=3 μg/mL |
63
|
21
|
| Serotype III >=5 μg/mL |
51
|
11
|
| Serotype III >=8 μg/mL |
49
|
5
|
| Title | Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. |
|---|---|
| Description | Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart . |
| Time Frame | Day 61, one month after the second vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS - primary, non-pregnant subjects |
| Arm/Group Title | Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non-pregnant/Placebo |
|---|---|---|
| Arm/Group Description | Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum | Non-pregnant women received two injections of saline solution |
| Measure Participants | 35 | 19 |
| Serotype Ia (N=34, 19) |
40
|
0.88
|
| Serotype Ib (N=33, 17) |
5.3
|
0.25
|
| Serotype III |
11
|
0.61
|
| Title | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. |
|---|---|
| Description | The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL. |
| Time Frame | Day 31, one month after vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS, secondary, maternal subjects, day 31, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at day 31 |
| Arm/Group Title | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo |
|---|---|---|---|---|
| Arm/Group Description | Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of saline solution |
| Measure Participants | 75 | 74 | 69 | 76 |
| serotype Ia>=1μg/mL (N=75, 74, 69, 75) |
85
|
77
|
88
|
33
|
| serotype Ia>=2μg/mL (N=75, 74, 69, 75) |
79
|
77
|
81
|
27
|
| serotype Ia>=3μg/mL (N=75, 74, 69, 75) |
76
|
73
|
78
|
23
|
| serotype Ia>=5μg/mL (N=75, 74, 69, 75) |
75
|
70
|
71
|
15
|
| serotype Ia>=8μg/mL (N=75, 74, 69, 75) |
71
|
70
|
71
|
9
|
| serotype Ib>=1μg/mL (N= 65, 69, 66, 61) |
65
|
68
|
62
|
21
|
| serotype Ib>=2μg/mL (N= 65, 69, 66, 61) |
60
|
54
|
50
|
13
|
| serotype Ib>=3μg/mL (N= 65, 69, 66, 61) |
54
|
48
|
44
|
11
|
| serotype Ib>=5μg/mL (N= 65, 69, 66, 61) |
48
|
43
|
36
|
10
|
| serotype Ib>=8μg/mL (N= 65, 69, 66, 61) |
43
|
39
|
30
|
8
|
| serotype III>=1μg/mL (N= 73, 74, 68, 76) |
70
|
65
|
57
|
13
|
| serotype III>=2μg/mL (N=73, 74, 68, 76) |
58
|
54
|
51
|
12
|
| serotype III>=3μg/mL (N=73, 74, 68, 76) |
48
|
50
|
44
|
4
|
| serotype III>=5μg/mL (N=73, 74, 68, 76) |
41
|
43
|
32
|
3
|
| serotype III>=8μg/mL (N=73, 74, 68, 76) |
38
|
34
|
29
|
3
|
| Title | The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. |
|---|---|
| Description | The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL. |
| Time Frame | Day of delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS primary, maternal subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and at delivery |
| Arm/Group Title | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo |
|---|---|---|---|---|
| Arm/Group Description | Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of saline solution |
| Measure Participants | 76 | 77 | 73 | 78 |
| Serotype Ia >= 1 μg/mL (N=76,77, 73, 76) |
86
|
83
|
89
|
38
|
| Serotype Ia >= 2 μg/mL (N=76, 77, 73, 76) |
78
|
74
|
81
|
26
|
| Serotype Ia >= 3 μg/mL (N=76, 77, 73, 76) |
75
|
71
|
77
|
21
|
| Serotype Ia >= 5 μg/mL (N=76, 77, 73, 76) |
72
|
69
|
75
|
18
|
| Serotype Ia >= 8 μg/mL (N=76, 77, 73, 76) |
64
|
64
|
71
|
9
|
| Serotype Ib >= 1 μg/mL (N=69, 74, 71, 58) |
58
|
65
|
65
|
14
|
| Serotype Ib >= 2 μg/mL (69, 74, 71, 58) |
52
|
51
|
48
|
10
|
| Serotype Ib >= 3 μg/mL (N=69, 74, 71, 58) |
43
|
49
|
42
|
10
|
| Serotype Ib >= 5 μg/mL (N=69, 74, 71, 58) |
41
|
41
|
37
|
9
|
| Serotype Ib >= 8 μg/mL (N=69, 74, 71, 58) |
36
|
36
|
32
|
3
|
| Serotype Ill >= 1 μg/mL (N=74, 77, 73, 78) |
69
|
66
|
64
|
14
|
| Serotype Ill >= 2 μg/mL (N=74, 77, 73, 78) |
62
|
53
|
51
|
9
|
| Serotype Ill >= 3 μg/mL (N=74, 77, 73, 78) |
49
|
44
|
42
|
4
|
| Serotype Ill >= 5 μg/mL (N=74, 77, 73, 78) |
39
|
49
|
36
|
3
|
| Serotype Ill >= 8 μg/mL (N=74, 77, 73, 78) |
34
|
35
|
29
|
3
|
| Title | Antibody GMC in Maternal Subjects at Day of Delivery |
|---|---|
| Description | Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported. |
| Time Frame | Day of delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS primary, maternal subjects |
| Arm/Group Title | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo |
|---|---|---|---|---|
| Arm/Group Description | Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of saline solution |
| Measure Participants | 76 | 77 | 73 | 78 |
| Serotype Ia (N= 76, 77, 73, 76) |
9.95
|
14
|
24
|
0.67
|
| Serotype Ib (N=69, 74, 71, 58) |
2.5
|
4.3
|
2.93
|
0.38
|
| Serotype III (N=74, 77, 73, 78) |
2.63
|
3.66
|
2.83
|
0.25
|
| Title | Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination |
|---|---|
| Description | Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo. |
| Time Frame | day 31 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS, secondary, maternal subjects, day 31 |
| Arm/Group Title | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo |
|---|---|---|---|---|
| Arm/Group Description | Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of saline solution |
| Measure Participants | 75 | 74 | 69 | 76 |
| serotype Ia (N=75, 74, 69, 75) |
13
|
15
|
26
|
0.62
|
| serotype Ib (N=65, 69, 66, 61) |
2.78
|
5.42
|
3.66
|
0.3
|
| serotype III (N=73, 74, 68, 76) |
3.01
|
4.11
|
2.77
|
0.19
|
| Title | The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. |
|---|---|
| Description | The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL. |
| Time Frame | Day 361, one year after the first vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS persistence, non-pregnant subjects, i.e. all enrolled subjects who provided at least one evaluable serum sample result at day 1 (prior to vaccination) and day 361. |
| Arm/Group Title | Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non-pregnant/Placebo |
|---|---|---|
| Arm/Group Description | Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum | Non-pregnant women received two injections of saline solution |
| Measure Participants | 37 | 20 |
| Serotype Ia >=1μg/mL |
86
|
30
|
| Serotype Ia >=2μg/mL |
76
|
30
|
| Serotype Ia >=3μg/mL |
76
|
25
|
| Serotype Ia >=5μg/mL |
70
|
15
|
| Serotype Ia >=8μg/mL |
62
|
10
|
| Serotype Ib >=1μg/mL (N=37, 19) |
81
|
21
|
| Serotype Ib >=2μg/mL (N=37, 19) |
65
|
16
|
| Serotype Ib >=3μg/mL (37, 19) |
62
|
5
|
| Serotype Ib >=5μg/mL (N=37, 19) |
38
|
5
|
| Serotype Ib >=8μg/mL (N=37, 19) |
32
|
5
|
| Serotype III >=1μg/mL |
81
|
20
|
| Serotype III >=2μg/mL |
70
|
15
|
| Serotype III >=3μg/mL |
65
|
15
|
| Serotype III >=5μg/mL |
54
|
5
|
| Serotype III >=8μg/mL |
41
|
5
|
| Title | Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination |
|---|---|
| Description | Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination. |
| Time Frame | Day 361, one year after the first vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS persistence, non-pregnant subjects |
| Arm/Group Title | Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non-pregnant/Placebo |
|---|---|---|
| Arm/Group Description | Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum | Non-pregnant women received two injections of saline solution |
| Measure Participants | 37 | 20 |
| serotype Ia |
15
|
0.86
|
| serotype Ib (N=37, 19) |
5.28
|
0.4
|
| serotype III |
7.03
|
0.3
|
| Title | Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events |
|---|---|
| Description | Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported. |
| Time Frame | Day 61 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety set, solicited and unsolicited reactogenicity, non-pregnant subjects |
| Arm/Group Title | Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non Pregnant/Placebo |
|---|---|---|
| Arm/Group Description | Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum | Non pregnant women received two injections of saline solution |
| Measure Participants | 40 | 20 |
| Solicited adverse events |
40
100%
|
19
95%
|
| Unsolicited adverse events |
30
75%
|
16
80%
|
| Title | Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events |
|---|---|
| Description | Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo. |
| Time Frame | From day 1 to one year after delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety set, solicited and unsolicited reactogenicity, maternal subjects |
| Arm/Group Title | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo |
|---|---|---|---|---|
| Arm/Group Description | Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of saline solution |
| Measure Participants | 80 | 80 | 80 | 80 |
| solicited adverse events (N=80, 80, 79, 80) |
59
147.5%
|
46
230%
|
59
73.8%
|
57
71.3%
|
| unsolicited adverse events |
70
175%
|
59
295%
|
62
77.5%
|
69
86.3%
|
| Title | Antibody GMC Per Serotype at Different Time Points in Infants |
|---|---|
| Description | Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo. |
| Time Frame | Day 4, day 43 and day 91 after birth |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per Protocol Set, infants, i.e. all subjects who provided evaluable serum samples at birth, study day 43, study day 91 and within the required time frames |
| Arm/Group Title | Infants 0.5/0.5/0.5 μg | Infants 2.5/2.5/2.5 μg | Infants 5/5/5 μg | Infants / Placebo |
|---|---|---|---|---|
| Arm/Group Description | Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received saline solution |
| Measure Participants | 75 | 77 | 69 | 76 |
| Serotype Ia (day 4; N=75, 76, 69, 73) |
6.66
|
6.52
|
12
|
0.49
|
| Serotype Ia (day 43; N= 75, 76, 68, 71) |
3.21
|
2.95
|
5.54
|
0.31
|
| Serotype Ia (day 91; N=71, 75, 64, 75) |
1.97
|
2.22
|
2.78
|
0.38
|
| Serotype Ib (day 4; N=71, 71, 66, 62) |
1.15
|
1.72
|
1.39
|
0.21
|
| Serotype Ib (day 43; N=72, 77, 67, 69) |
0.73
|
0.88
|
0.67
|
0.15
|
| Serotype Ib (day 91; N= 74, 73, 66, 76) |
0.85
|
1.08
|
0.83
|
0.5
|
| Serotype III (day 4; N= 57, 64, 58, 52) |
2.11
|
2.3
|
1.72
|
0.29
|
| Serotype III (day 43; N= 64, 75, 61, 63) |
0.82
|
0.88
|
0.68
|
0.16
|
| Serotype III (day 91; N= 63, 63, 57, 69) |
0.6
|
0.69
|
0.51
|
0.27
|
| Title | Number of Infants Reporting Serious Adverse Events |
|---|---|
| Description | Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events |
| Time Frame | one year after birth |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Infants 0.5/0.5/0.5 μg | Infants 2.5/2.5/2.5 μg | Infants 5/5/5 μg | Infants / Placebo |
|---|---|---|---|---|
| Arm/Group Description | Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received saline solution |
| Measure Participants | 79 | 79 | 74 | 78 |
| Serious AEs |
19
|
13
|
13
|
18
|
| At least possibly related SAEs |
0
|
0
|
0
|
0
|
| AEs leading to withdrawal |
1
|
2
|
0
|
1
|
| AEs leading to death |
1
|
2
|
0
|
1
|
Adverse Events
| Time Frame | Solicited AEs were collected from day 1 to 7 after vaccination; unsolicited AEs and SAEs were collected from day 1 to day 361. | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Analyses was done on the Safety Population. Solicited AEs were collected through systematic assessment, unsolicited AEs were collected through non-systematic assesment. | |||||||||||||||||||
| Arm/Group Title | Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non-pregnant/Placebo | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo | Infants 0.5/0.5/0.5 μg | Infants 2.5/2.5/2.5 μg | Infants 5/5/5 μg | Infants / Placebo | ||||||||||
| Arm/Group Description | Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum | Non-pregnant women received two injections of saline solution | Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Pregnant women who received one injection of saline solution | Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine | Infants born from women who received one injection of saline solution | ||||||||||
All Cause Mortality |
||||||||||||||||||||
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non-pregnant/Placebo | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo | Infants 0.5/0.5/0.5 μg | Infants 2.5/2.5/2.5 μg | Infants 5/5/5 μg | Infants / Placebo | |||||||||||
| 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 | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||
Serious Adverse Events |
||||||||||||||||||||
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non-pregnant/Placebo | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo | Infants 0.5/0.5/0.5 μg | Infants 2.5/2.5/2.5 μg | Infants 5/5/5 μg | Infants / Placebo | |||||||||||
| 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 | 2/40 (5%) | 1/20 (5%) | 27/80 (33.8%) | 24/80 (30%) | 25/80 (31.3%) | 30/80 (37.5%) | 19/79 (24.1%) | 13/79 (16.5%) | 13/74 (17.6%) | 18/78 (23.1%) | ||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||
| anemia | 0/40 (0%) | 0/20 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 2/74 (2.7%) | 0/78 (0%) | ||||||||||
| Thrombocytopenia | 0/40 (0%) | 0/20 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Cardiac disorders | ||||||||||||||||||||
| Tachycardia foetal | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 1/80 (1.3%) | 1/80 (1.3%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| cardiac disorder | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Congenital, familial and genetic disorders | ||||||||||||||||||||
| congenital pneumonia | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Endocrine disorders | ||||||||||||||||||||
| Thyroid mass | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Eye disorders | ||||||||||||||||||||
| strabism | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| constipation | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| diarrhoea | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| vomiting | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 2/79 (2.5%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| General disorders | ||||||||||||||||||||
| pyrexia | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Hepatobiliary disorders | ||||||||||||||||||||
| jaundice | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 1/74 (1.4%) | 1/78 (1.3%) | ||||||||||
| Immune system disorders | ||||||||||||||||||||
| hypersensitivity | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| abscess limb | 1/40 (2.5%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| acute tonsillitis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| bronchiolitis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 3/79 (3.8%) | 2/79 (2.5%) | 1/74 (1.4%) | 3/78 (3.8%) | ||||||||||
| bronchopneumonia | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 2/79 (2.5%) | 0/79 (0%) | 0/74 (0%) | 2/78 (2.6%) | ||||||||||
| bullous impetigo | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| cellulitis | 1/40 (2.5%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| chorioamnionitis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 1/80 (1.3%) | 1/80 (1.3%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| dysentery | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| eczema herpeticum | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| gastroenteritis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 4/79 (5.1%) | 0/79 (0%) | 3/74 (4.1%) | 3/78 (3.8%) | ||||||||||
| HIV infection | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 1/74 (1.4%) | 0/78 (0%) | ||||||||||
| klebsiella sepsis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| lower respiratory tract infection | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| meningitis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| otitis media | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| pneumonia | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| postoperative wound infection | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| postpartum sepsis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| pyelonephritis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| respiratory syncytial virus bronchiolitis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| sepsis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| sepsis neonatal | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 2/79 (2.5%) | 3/79 (3.8%) | 3/74 (4.1%) | 1/78 (1.3%) | ||||||||||
| streptococcal sepsis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| umbilical sepsis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| upper respiratory tract infection | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| urinary tract infection | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 1/80 (1.3%) | 1/80 (1.3%) | 1/80 (1.3%) | 1/79 (1.3%) | 1/79 (1.3%) | 2/74 (2.7%) | 0/78 (0%) | ||||||||||
| urinary tract infection bacteria | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| wound sepsis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| burns second degree | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| perineal laceration | 0/40 (0%) | 0/20 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| post procedural haemorrhage | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| seroma | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| thermal burn | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| vulvovaginal injury | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| wound secretion | 0/40 (0%) | 0/20 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Investigations | ||||||||||||||||||||
| coagulation factor IX level decreased | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||
| dehydration | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| failure to thrive | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 1/74 (1.4%) | 0/78 (0%) | ||||||||||
| hypernatraemia | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 2/74 (2.7%) | 0/78 (0%) | ||||||||||
| hyperkalaemia | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| hypoglycaemia | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 1/79 (1.3%) | 1/74 (1.4%) | 0/78 (0%) | ||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| back pain | 0/40 (0%) | 1/20 (5%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| dizziness | 0/40 (0%) | 1/20 (5%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| convulsion | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 1/79 (1.3%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| convulsion neonatal | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| hypoxic-ischaemic encephalopathy | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||||||||
| abortion spontaneous | 1/40 (2.5%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| jaundice neonatal | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 2/79 (2.5%) | 3/79 (3.8%) | 2/74 (2.7%) | 3/78 (3.8%) | ||||||||||
| low birth weight baby | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| premature baby | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| breech presentation | 0/40 (0%) | 0/20 (0%) | 2/80 (2.5%) | 1/80 (1.3%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| cephalo-pelvic disproportion | 0/40 (0%) | 0/20 (0%) | 2/80 (2.5%) | 2/80 (2.5%) | 1/80 (1.3%) | 5/80 (6.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| eclampsia | 0/40 (0%) | 0/20 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| failed induction of labour | 0/40 (0%) | 0/20 (0%) | 1/80 (1.3%) | 4/80 (5%) | 4/80 (5%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| false labour | 0/40 (0%) | 0/20 (0%) | 2/80 (2.5%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| foetal death | 0/40 (0%) | 0/20 (0%) | 1/80 (1.3%) | 0/80 (0%) | 1/80 (1.3%) | 2/80 (2.5%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| foetal distress syndrome | 0/40 (0%) | 0/20 (0%) | 10/80 (12.5%) | 4/80 (5%) | 9/80 (11.3%) | 11/80 (13.8%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| foetal hypokinesia | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| gestational hypertension | 0/40 (0%) | 0/20 (0%) | 3/80 (3.8%) | 4/80 (5%) | 2/80 (2.5%) | 12/80 (15%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| haemorrage in pregnancy | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| hyperemesis gravidarum | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| labour complication | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| oligohydramnios | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| postpartum haemorrage | 0/40 (0%) | 0/20 (0%) | 2/80 (2.5%) | 3/80 (3.8%) | 2/80 (2.5%) | 2/80 (2.5%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| pre-eclampsia | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 2/80 (2.5%) | 2/80 (2.5%) | 2/80 (2.5%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| premature labour | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| premature rupture of membranes | 0/40 (0%) | 0/20 (0%) | 1/80 (1.3%) | 2/80 (2.5%) | 2/80 (2.5%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| premature separation of placenta | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| prolonged labour | 0/40 (0%) | 0/20 (0%) | 6/80 (7.5%) | 4/80 (5%) | 1/80 (1.3%) | 5/80 (6.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| prolonged pregnancy | 0/40 (0%) | 0/20 (0%) | 1/80 (1.3%) | 1/80 (1.3%) | 2/80 (2.5%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| retained product of conception | 0/40 (0%) | 0/20 (0%) | 2/80 (2.5%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| stillbirth | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 1/80 (1.3%) | 1/80 (1.3%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| umbilical cord prolapse | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Renal and urinary disorders | ||||||||||||||||||||
| hydronephrosis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| renal impairment | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||
| vaginal haemorrage | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| acute respiratory distress syndrome | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| neonathal asphyxia | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 1/79 (1.3%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| transient tachypnoea of the newborn | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 2/79 (2.5%) | 4/74 (5.4%) | 4/78 (5.1%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| erythema toxicum neonatorum | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Surgical and medical procedures | ||||||||||||||||||||
| labour induction | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Vascular disorders | ||||||||||||||||||||
| hypertension | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| subgaleal haematoma | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 1/74 (1.4%) | 0/78 (0%) | ||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| Non-pregnant 20/20/20 μg +Aluminum Hydroxide | Non-pregnant/Placebo | Pregnant 0.5/0.5/0.5 μg | Pregnant 2.5/2.5/2.5 μg | Pregnant 5/5/5 μg | Pregnant/Placebo | Infants 0.5/0.5/0.5 μg | Infants 2.5/2.5/2.5 μg | Infants 5/5/5 μg | Infants / Placebo | |||||||||||
| 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 | 40/40 (100%) | 19/20 (95%) | 72/80 (90%) | 67/80 (83.8%) | 70/80 (87.5%) | 71/80 (88.8%) | 44/79 (55.7%) | 49/79 (62%) | 48/74 (64.9%) | 51/78 (65.4%) | ||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||
| anaemia | 4/40 (10%) | 1/20 (5%) | 1/80 (1.3%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Eye disorders | ||||||||||||||||||||
| conjunctivitis | 0/40 (0%) | 0/20 (0%) | 2/80 (2.5%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 4/79 (5.1%) | 6/79 (7.6%) | 7/74 (9.5%) | 3/78 (3.8%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| nausea | 17/40 (42.5%) | 6/20 (30%) | 16/80 (20%) | 7/80 (8.8%) | 17/80 (21.3%) | 8/80 (10%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| constipation | 0/40 (0%) | 0/20 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 2/79 (2.5%) | 4/79 (5.1%) | 3/74 (4.1%) | 3/78 (3.8%) | ||||||||||
| General disorders | ||||||||||||||||||||
| chills | 15/40 (37.5%) | 6/20 (30%) | 16/80 (20%) | 7/80 (8.8%) | 8/80 (10%) | 9/80 (11.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| fatigue | 29/40 (72.5%) | 12/20 (60%) | 39/80 (48.8%) | 34/80 (42.5%) | 43/80 (53.8%) | 37/80 (46.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| feeling hot | 3/40 (7.5%) | 1/20 (5%) | 2/80 (2.5%) | 1/80 (1.3%) | 1/80 (1.3%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| injection site induration | 19/40 (47.5%) | 4/20 (20%) | 7/80 (8.8%) | 9/80 (11.3%) | 9/80 (11.3%) | 3/80 (3.8%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| injection site erythema | 12/40 (30%) | 3/20 (15%) | 10/80 (12.5%) | 8/80 (10%) | 7/80 (8.8%) | 2/80 (2.5%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| injection site haemorrhage | 7/40 (17.5%) | 3/20 (15%) | 1/80 (1.3%) | 4/80 (5%) | 3/80 (3.8%) | 2/80 (2.5%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| injection site pain | 39/40 (97.5%) | 15/20 (75%) | 28/80 (35%) | 25/80 (31.3%) | 26/80 (32.5%) | 24/80 (30%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| injection site swelling | 14/40 (35%) | 2/20 (10%) | 2/80 (2.5%) | 5/80 (6.3%) | 5/80 (6.3%) | 1/80 (1.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| injection site warmth | 24/40 (60%) | 9/20 (45%) | 21/80 (26.3%) | 12/80 (15%) | 15/80 (18.8%) | 15/80 (18.8%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| malaise | 14/40 (35%) | 7/20 (35%) | 14/80 (17.5%) | 13/80 (16.3%) | 17/80 (21.3%) | 16/80 (20%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| pain | 10/40 (25%) | 3/20 (15%) | 2/80 (2.5%) | 1/80 (1.3%) | 1/80 (1.3%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| pyrexia | 6/40 (15%) | 0/20 (0%) | 5/80 (6.3%) | 1/80 (1.3%) | 4/80 (5%) | 2/80 (2.5%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| tonsillitis | 3/40 (7.5%) | 0/20 (0%) | 0/80 (0%) | 4/80 (5%) | 4/80 (5%) | 3/80 (3.8%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| induration | 4/40 (10%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Influenza like illness | 1/40 (2.5%) | 0/20 (0%) | 2/80 (2.5%) | 1/80 (1.3%) | 0/80 (0%) | 8/80 (10%) | 3/79 (3.8%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Hepatobiliary disorders | ||||||||||||||||||||
| jaundice | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 5/79 (6.3%) | 2/79 (2.5%) | 5/74 (6.8%) | 2/78 (2.6%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| influenza | 1/40 (2.5%) | 1/20 (5%) | 8/80 (10%) | 2/80 (2.5%) | 15/80 (18.8%) | 5/80 (6.3%) | 0/79 (0%) | 1/79 (1.3%) | 1/74 (1.4%) | 0/78 (0%) | ||||||||||
| upper respiratory tract infection | 3/40 (7.5%) | 1/20 (5%) | 26/80 (32.5%) | 26/80 (32.5%) | 34/80 (42.5%) | 32/80 (40%) | 21/79 (26.6%) | 26/79 (32.9%) | 18/74 (24.3%) | 24/78 (30.8%) | ||||||||||
| urinary tract infection | 1/40 (2.5%) | 1/20 (5%) | 2/80 (2.5%) | 4/80 (5%) | 7/80 (8.8%) | 8/80 (10%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 1/78 (1.3%) | ||||||||||
| bronchiolitis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 1/79 (1.3%) | 5/79 (6.3%) | 3/74 (4.1%) | 3/78 (3.8%) | ||||||||||
| fungal skin infection | 1/40 (2.5%) | 1/20 (5%) | 0/80 (0%) | 1/80 (1.3%) | 2/80 (2.5%) | 2/80 (2.5%) | 9/79 (11.4%) | 10/79 (12.7%) | 10/74 (13.5%) | 6/78 (7.7%) | ||||||||||
| gastroenteritis | 2/40 (5%) | 0/20 (0%) | 1/80 (1.3%) | 2/80 (2.5%) | 1/80 (1.3%) | 1/80 (1.3%) | 6/79 (7.6%) | 7/79 (8.9%) | 1/74 (1.4%) | 3/78 (3.8%) | ||||||||||
| oral candidiasis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 0/79 (0%) | 1/79 (1.3%) | 4/74 (5.4%) | 4/78 (5.1%) | ||||||||||
| Investigations | ||||||||||||||||||||
| aspartate aminotransferase increased | 1/40 (2.5%) | 2/20 (10%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| arthralgia | 23/40 (57.5%) | 6/20 (30%) | 20/80 (25%) | 14/80 (17.5%) | 15/80 (18.8%) | 20/80 (25%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| myalgia | 29/40 (72.5%) | 11/20 (55%) | 20/80 (25%) | 23/80 (28.8%) | 26/80 (32.5%) | 19/80 (23.8%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| neck pain | 0/40 (0%) | 2/20 (10%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| dizziness | 0/40 (0%) | 0/20 (0%) | 1/80 (1.3%) | 1/80 (1.3%) | 5/80 (6.3%) | 5/80 (6.3%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| headache | 28/40 (70%) | 15/20 (75%) | 47/80 (58.8%) | 25/80 (31.3%) | 44/80 (55%) | 34/80 (42.5%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||
| vaginal discharge | 0/40 (0%) | 0/20 (0%) | 2/80 (2.5%) | 6/80 (7.5%) | 9/80 (11.3%) | 7/80 (8.8%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| cough | 3/40 (7.5%) | 0/20 (0%) | 3/80 (3.8%) | 3/80 (3.8%) | 7/80 (8.8%) | 6/80 (7.5%) | 1/79 (1.3%) | 1/79 (1.3%) | 1/74 (1.4%) | 1/78 (1.3%) | ||||||||||
| nasal congestion | 2/40 (5%) | 0/20 (0%) | 0/80 (0%) | 2/80 (2.5%) | 4/80 (5%) | 6/80 (7.5%) | 9/79 (11.4%) | 17/79 (21.5%) | 20/74 (27%) | 15/78 (19.2%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| rash | 4/40 (10%) | 0/20 (0%) | 4/80 (5%) | 3/80 (3.8%) | 5/80 (6.3%) | 0/80 (0%) | 1/79 (1.3%) | 1/79 (1.3%) | 2/74 (2.7%) | 1/78 (1.3%) | ||||||||||
| dermatitis | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 1/80 (1.3%) | 0/80 (0%) | 11/79 (13.9%) | 6/79 (7.6%) | 4/74 (5.4%) | 6/78 (7.7%) | ||||||||||
| dermatitis diaper | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 3/79 (3.8%) | 1/79 (1.3%) | 8/74 (10.8%) | 6/78 (7.7%) | ||||||||||
| eczema | 0/40 (0%) | 0/20 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) | 4/79 (5.1%) | 8/79 (10.1%) | 5/74 (6.8%) | 12/78 (15.4%) | ||||||||||
| Vascular disorders | ||||||||||||||||||||
| hypertension | 3/40 (7.5%) | 0/20 (0%) | 4/80 (5%) | 3/80 (3.8%) | 6/80 (7.5%) | 6/80 (7.5%) | 0/79 (0%) | 0/79 (0%) | 0/74 (0%) | 0/78 (0%) | ||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Other disclosure agreement: the terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
| Name/Title | Posting Director |
|---|---|
| Organization | Novartis Vaccines and Diagnostics |
| Phone | |
| RegistryContactVaccinesUS@novartis.com |
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT01193920
Other Study ID Numbers:
- V98_08
- MCC Reference n° 20100601
First Posted:
Sep 2, 2010
Last Update Posted:
Aug 22, 2014
Last Verified:
Aug 1, 2014