Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT01412801
Collaborator
(none)
270
2
3
15
135
9
Study Details
Study Description
Brief Summary
The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the study investigated the maternal to fetal transfer of antibodies induced by the investigational vaccine.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
270 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women
Study Start Date
:
Sep 1, 2011
Actual Primary Completion Date
:
Oct 1, 2012
Actual Study Completion Date
:
Dec 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HIVneg HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of Group B streptococcus vaccine. |
Biological: Group B streptococcus vaccine
Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.
|
| Experimental: HIVposCD4HIGH HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of Group B streptococcus vaccine. |
Biological: Group B streptococcus vaccine
Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.
|
| Experimental: HIVposCD4LOW HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of Group B streptococcus vaccine |
Biological: Group B streptococcus vaccine
Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth [Day of delivery/birth]
GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
- Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth. [Day of delivery/birth]
The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.
Secondary Outcome Measures
- Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery [Day 1, 15, 31 and at Delivery]
Immunogenicity was measured as Geometric Mean Concentration of Antibody levels for GBS Serotypes Ia, Ib and III after receiving one dose of GBS Trivalent Vaccine.
- Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery [Day of Delivery]
Immunogenicity was measured in terms of the percentages of maternal subjects with ELISA Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold after receiving one dose of GBS Trivalent Vaccine.Threshold values of 0.1, 0.2, 0.5, 1, 2, 3, 5, and 8 μg/mL were used for serum concentrations for maternal subjects.
- Percentages of Subjects With Solicited Local Adverse Events (AEs) [From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks]
Safety was assessed in terms of the number of subjects with solicited local AEs after receiving one dose of the GBS Trivalent Vaccine
- Percentages of Subjects With Solicited Systemic AEs [From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks]
Safety was assessed in terms of the number of subjects with solicited systemic AEs after receiving one dose of the GBS Trivalent Vaccine
- Percentages of Subjects Who Experienced Unsolicited Adverse Events [Day 1 to Study Termination, for up to 24 weeks]
Safety was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events after receiving one dose of the GBS Trivalent Vaccine
- Percentages of Infants Who Experienced Unsolicited Adverse Events [Birth to Study Termination, for up to 24 weeks]
Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Pregnant women 18-40 years of age between 24-35 weeks gestation
-
Women who were HIVneg or HIVpos with WHO stage I or II disease and with CD4+ counts > 50 cells/µL
Exclusion Criteria:
-
Women who had CD4+ count ≤ 50 cells/µL
-
Women who were HIVpos with WHO stage III or IV disease, history of severe allergic reactions after previous vaccinations
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Limbe Health Center | Blantyre | Malawi | ||
| 2 | Chris Hani Baragwanath Hospital | Bertsham | South Africa | 2013 |
Sponsors and Collaborators
- Novartis Vaccines
Investigators
- Study Chair: Novartis Vaccines, Novartis Vaccines
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT01412801
Other Study ID Numbers:
- V98_05
First Posted:
Aug 9, 2011
Last Update Posted:
Sep 12, 2014
Last Verified:
Sep 1, 2014
Keywords provided by Novartis Vaccines
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were enrolled at Malawi and South Africa |
|---|---|
| Pre-assignment Detail | All the enrolled subjects are included in the trial. Also,only the mothers who received the glycoconjugates were considered enrolled. |
| Arm/Group Title | HIVposCD4LOW_Maternal | HIVposCD4HIGH_Maternal | HIVneg_Maternal | HIVposCD4LOW(Infants) | HIVposCD4HIGH(Infants) | HIVneg(Infants) |
|---|---|---|---|---|---|---|
| Arm/Group Description | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL . | Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL | Infants born to HIV-antibody negative maternal subjects |
| Period Title: Overall Study | ||||||
| STARTED | 91 | 89 | 90 | 91 | 88 | 87 |
| COMPLETED | 87 | 84 | 83 | 87 | 85 | 84 |
| NOT COMPLETED | 4 | 5 | 7 | 4 | 3 | 3 |
Baseline Characteristics
| Arm/Group Title | HIVposCD4LOW_Maternal | HIVposCD4HIGH_Maternal | HIVneg_Maternal | HIVposCD4LOW (Infants) | HIVposCD4HIGH (Infants) | HIVneg (Infants) | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL | Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL | Infants born to HIV-antibody negative maternal subjects | Total of all reporting groups |
| Overall Participants | 91 | 89 | 90 | 91 | 88 | 87 | 536 |
| Age, Customized (years) [Mean (Standard Deviation) ] | |||||||
| Maternal Subjects |
28.3
(4.8)
|
28.1
(5.2)
|
24.7
(4.4)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
27.1
(5.0)
|
| Age, Customized (days) [Mean (Standard Deviation) ] | |||||||
| Infants |
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
4.1
(1.6)
|
6.7
(2.5)
|
1.3
(1.1)
|
1.6
(1.0)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
91
100%
|
89
100%
|
90
100%
|
42
46.2%
|
40
45.5%
|
41
47.1%
|
393
73.3%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
49
53.8%
|
48
54.5%
|
46
52.9%
|
143
26.7%
|
Outcome Measures
| Title | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth |
|---|---|
| Description | GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented. |
| Time Frame | Day of delivery/birth |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable). |
| Arm/Group Title | HIVposCD4LOW_Maternal | HIVposCD4HIGH_Maternal | HIVneg_Maternal | HIVposCD4LOW(Infants) | HIVposCD4HIGH(Infants) | HIVneg(Infants) |
|---|---|---|---|---|---|---|
| Arm/Group Description | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL . | Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL | Infants born to HIV-antibody negative maternal subjects |
| Measure Participants | 83 | 81 | 83 | 83 | 81 | 83 |
| GBS serotypes Ia (83, 81, 83, 79, 81, 83) |
2.07
|
2.31
|
3.98
|
1.01
|
1.22
|
3.91
|
| GBS serotypes Ib(74, 80, 82, 44, 56, 57) |
1.84
|
2.4
|
4.08
|
1.31
|
1.62
|
2.67
|
| GBS serotypes III (83, 72, 82, 54, 51, 66) |
1.07
|
1.03
|
3.61
|
0.6
|
0.52
|
3.88
|
| Title | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery |
|---|---|
| Description | Immunogenicity was measured as Geometric Mean Concentration of Antibody levels for GBS Serotypes Ia, Ib and III after receiving one dose of GBS Trivalent Vaccine. |
| Time Frame | Day 1, 15, 31 and at Delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Maternal Subjects in the Exposed Population) who -Secondary objective serum GMC: provided at least one evaluable sample result at day 1 (prior to vaccination), day 15, day 31, or at delivery;- Secondary objective kinetics: provided at least one evaluable serum sample at day 1 (prior to vaccination), day 15, day 31, and at delivery. |
| Arm/Group Title | HIVposCD4LOW_Maternal | HIVposCD4HIGH_Maternal | HIVneg_Maternal |
|---|---|---|---|
| Arm/Group Description | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine |
| Measure Participants | 74 | 75 | 77 |
| Serotype Ia Day 1 |
0.24
|
0.25
|
0.38
|
| Serotype Ia Day 15 |
2.62
|
2.95
|
5.61
|
| Serotype Ia Day 31 |
2.68
|
3.26
|
6.63
|
| Serotype Ia At delivery |
2.22
|
2.69
|
4.49
|
| Serotype Ib Day 1 |
0.51
|
0.36
|
0.4
|
| Serotype Ib Day 15 |
2.93
|
3.5
|
6.07
|
| Serotype Ib Day 31 |
2.62
|
3.68
|
5.35
|
| Serotype Ib At delivery |
2.12
|
3.04
|
3.84
|
| Serotype III Day 1 |
0.12
|
0.099
|
0.14
|
| Serotype III Day 15 |
1.24
|
1.52
|
5.9
|
| Serotype III Day 31 |
1.51
|
1.31
|
5.35
|
| Serotype III At delivery |
1.25
|
1.07
|
3.8
|
| Title | Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery |
|---|---|
| Description | Immunogenicity was measured in terms of the percentages of maternal subjects with ELISA Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold after receiving one dose of GBS Trivalent Vaccine.Threshold values of 0.1, 0.2, 0.5, 1, 2, 3, 5, and 8 μg/mL were used for serum concentrations for maternal subjects. |
| Time Frame | Day of Delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS (Maternal Subjects) |
| Arm/Group Title | HIVposCD4LOW_Maternal | HIVposCD4HIGH_Maternal | HIVneg_Maternal |
|---|---|---|---|
| Arm/Group Description | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine. |
| Measure Participants | 83 | 82 | 83 |
| ≥ 0.2 µg/mL(Serotype Ia) |
100
|
99
|
100
|
| ≥ 0.5 µg/mL(Serotype Ia) |
67
|
71
|
82
|
| ≥ 1 µg/mL(Serotype Ia) |
55
|
59
|
71
|
| ≥ 2 µg/mL(Serotype Ia) |
51
|
49
|
60
|
| ≥ 3 µg/mL(Serotype Ia) |
40
|
46
|
54
|
| ≥ 5 µg/mL(Serotype Ia) |
30
|
41
|
53
|
| ≥ 8 µg/mL(Serotype Ia) |
22
|
30
|
47
|
| ≥ 0.1 µg/mL(Serotype Ib) |
89
|
98
|
98
|
| ≥ 0.2 µg/mL(Serotype Ib) |
88
|
98
|
98
|
| ≥ 0.5 µg/mL(Serotype Ib) |
83
|
84
|
90
|
| ≥ 1 µg/mL(Serotype Ib) |
65
|
63
|
69
|
| ≥ 2 µg/mL(Serotype Ib) |
40
|
41
|
47
|
| ≥ 3 µg/mL(Serotype Ib) |
28
|
35
|
40
|
| ≥ 5 µg/mL(Serotype Ib) |
20
|
26
|
28
|
| ≥ 8 µg/mL(Serotype Ib) |
13
|
17
|
24
|
| ≥ 0.1 µg/mL(Serotype III) |
96
|
80
|
95
|
| ≥ 0.2 µg/mL(Serotype III) |
82
|
76
|
89
|
| ≥ 0.5 µg/mL(Serotype III) |
63
|
51
|
86
|
| ≥ 1 µg/mL(Serotype III) |
47
|
41
|
73
|
| ≥ 2 µg/mL(Serotype III) |
36
|
24
|
64
|
| ≥ 3 µg/mL(Serotype III) |
29
|
18
|
54
|
| ≥ 5 µg/mL(Serotype III) |
18
|
13
|
49
|
| ≥ 8 µg/mL(Serotype III) |
17
|
12
|
40
|
| Title | Percentages of Subjects With Solicited Local Adverse Events (AEs) |
|---|---|
| Description | Safety was assessed in terms of the number of subjects with solicited local AEs after receiving one dose of the GBS Trivalent Vaccine |
| Time Frame | From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set (Solicited AEs, Maternal Subjects) |
| Arm/Group Title | HIVposCD4LOW_Maternal | HIVposCD4HIGH_Maternal | HIVneg_Maternal |
|---|---|---|---|
| Arm/Group Description | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine |
| Measure Participants | 88 | 88 | 90 |
| Ecchymosis(87, 88, 90) |
0
|
0
|
1
|
| Erythema(87, 88, 89) |
0
|
1
|
1
|
| Induration(87, 88, 90) |
0
|
1
|
0
|
| Swelling(87, 88, 90) |
0
|
0
|
2
|
| Pain(87, 88, 90) |
18
|
30
|
39
|
| Title | Percentages of Subjects With Solicited Systemic AEs |
|---|---|
| Description | Safety was assessed in terms of the number of subjects with solicited systemic AEs after receiving one dose of the GBS Trivalent Vaccine |
| Time Frame | From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set (Solicited AEs, Maternal Subjects) |
| Arm/Group Title | HIVposCD4LOW_Maternal | HIVposCD4HIGH_Maternal | HIVneg_Maternal |
|---|---|---|---|
| Arm/Group Description | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine |
| Measure Participants | 88 | 88 | 90 |
| Chills(87,88,90) |
9
|
14
|
22
|
| Nausea(87,88,89) |
13
|
17
|
22
|
| Malaise(87,88,90) |
10
|
19
|
23
|
| Myalgia(87,88,90) |
8
|
17
|
23
|
| Arthralgia(87,88,90) |
13
|
23
|
29
|
| Headache(87,88,90) |
24
|
32
|
43
|
| Fatigue(87,88,90) |
24
|
31
|
47
|
| Rash(87,88,90) |
3
|
1
|
1
|
| Fever ( ≥ 38°C)(87, 88, 90) |
3
|
0
|
0
|
| Temperature(<38°C)(87, 88,90) |
97
|
100
|
100
|
| Temperature(38-38.4°C)(87, 88,90) |
1
|
0
|
0
|
| Temperature(38.5-38.9°C)(87, 88,90) |
1
|
0
|
0
|
| Temperature(39-39.4°C)(87, 88,90) |
0
|
0
|
0
|
| Temperature(39.5-39.9°C)(87, 88,90) |
1
|
0
|
0
|
| Temperature(≥ 40°C)(87, 88,90) |
0
|
0
|
0
|
| Analgesic antipyr. meds(Other indicators) |
7
|
10
|
9
|
| Stayed home(Other indicators) |
3
|
5
|
9
|
| Title | Percentages of Subjects Who Experienced Unsolicited Adverse Events |
|---|---|
| Description | Safety was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events after receiving one dose of the GBS Trivalent Vaccine |
| Time Frame | Day 1 to Study Termination, for up to 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set (Unsolicited AEs, Maternal Subjects) |
| Arm/Group Title | HIVposCD4LOW_Maternal | HIVposCD4HIGH_Maternal | HIVneg_Maternal |
|---|---|---|---|
| Arm/Group Description | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine | HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine |
| Measure Participants | 90 | 89 | 90 |
| Any AE |
74
|
76
|
78
|
| Possibly related AE |
7
|
13
|
23
|
| SAE |
28
|
31
|
32
|
| Possibly related SAE |
0
|
0
|
0
|
| AE leading to withdrawal from study |
0
|
1
|
0
|
| Medically attended AEs |
47
|
49
|
54
|
| Death |
0
|
1
|
0
|
| Title | Percentages of Infants Who Experienced Unsolicited Adverse Events |
|---|---|
| Description | Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination |
| Time Frame | Birth to Study Termination, for up to 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Set (Unsolicited AEs, Infants) |
| Arm/Group Title | HIVposCD4LOW (Infants) | HIVposCD4HIGH (Infants) | HIVneg (Infants) |
|---|---|---|---|
| Arm/Group Description | Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL | Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL | Infants born to HIV-antibody negative maternal subjects |
| Measure Participants | 91 | 88 | 87 |
| Any AE |
41
|
49
|
43
|
| Possibly related AE |
0
|
2
|
1
|
| SAE |
19
|
18
|
18
|
| Possibly related SAE |
0
|
0
|
0
|
| AE leading to withdrawal from study |
4
|
2
|
2
|
| Medically attended AEs |
23
|
33
|
24
|
| Death |
4
|
2
|
2
|
| Title | Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth. |
|---|---|
| Description | The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery. |
| Time Frame | Day of delivery/birth |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable). |
| Arm/Group Title | HIVposCD4LOW | HIVposCD4HIGH | HIVneg |
|---|---|---|---|
| Arm/Group Description | Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL | Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL | Maternal subjects: HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine. Infants: Infants born to HIV-antibody negative maternal subjects |
| Measure Participants | 79 | 79 | 83 |
| Serotype Ia |
0.58
|
0.6
|
0.72
|
| Serotype Ib (41,54,57) |
0.51
|
0.64
|
0.49
|
| Serotype III (53,44,66) |
0.6
|
0.51
|
0.56
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HIVposCD4LOW_Maternal, HIVposCD4HIGH_Maternal |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group Ratios (Serotype Ia) |
| Estimated Value | 0.96 | |
| Confidence Interval |
(2-Sided) 98.4% 0.71 to 1.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HIVposCD4LOW_Maternal, HIVneg_Maternal |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios (Serotype Ia) |
| Estimated Value | 0.81 | |
| Confidence Interval |
(2-Sided) 98.4% 0.6 to 1.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HIVposCD4HIGH_Maternal, HIVneg_Maternal |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios (Serotype Ia) |
| Estimated Value | 0.84 | |
| Confidence Interval |
(2-Sided) 98.4% 0.63 to 1.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HIVposCD4LOW_Maternal, HIVposCD4HIGH_Maternal |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios (Serotype Ib) |
| Estimated Value | 0.8 | |
| Confidence Interval |
(2-Sided) 98.4% 0.49 to 1.29 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HIVposCD4LOW_Maternal, HIVneg_Maternal |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios (Serotype Ib) |
| Estimated Value | 1.05 | |
| Confidence Interval |
(2-Sided) 98.4% 0.65 to 1.69 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | HIVposCD4HIGH_Maternal, HIVneg_Maternal |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios (Serotype Ib) |
| Estimated Value | 1.32 | |
| Confidence Interval |
(2-Sided) 98.4% 0.85 to 2.06 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | HIVposCD4LOW_Maternal, HIVposCD4HIGH_Maternal |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios (Serotype III) |
| Estimated Value | 1.17 | |
| Confidence Interval |
(2-Sided) 98.4% 0.66 to 2.07 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | HIVposCD4LOW_Maternal, HIVneg_Maternal |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios (Serotype III) |
| Estimated Value | 1.06 | |
| Confidence Interval |
(2-Sided) 98.4% 0.63 to 1.78 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 9
| Statistical Analysis Overview | Comparison Group Selection | HIVposCD4HIGH_Maternal, HIVneg_Maternal |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Vaccine Group ratios (Serotype III) |
| Estimated Value | 0.91 | |
| Confidence Interval |
(2-Sided) 98.4% 0.52 to 1.58 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Throughout the study period, for up to 24 weeks | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All AEs or SAEs occurring from previous visit, relevant medical history, any new or continuing concomitant medications were recorded at the next visit. All AEs were collected until day 31 following vaccination and all AEs requiring a physician's visit from day 31 until the end of study. All SAEs were monitored throughout the entire study period. | |||||||||||||||
| Arm/Group Title | HIVposCD4LOW (Infants) | HIVposCD4HIGH (Infants) | HIVneg (Infants) | Total (Infants) | HIVposCD4LOW_Maternal Subjects | HIVposCD4HIGH_Maternal Subjects | HIVneg_Maternal Subjects | Total Maternal Subjects | ||||||||
| Arm/Group Description | Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/μL but > 50 cells/μL | Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/μL . | Infants born to HIV-antibody negative maternal subjects | Total number of Infants participated in the study | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/μL but > 50 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine. | HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine. | HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine. | Total number of Maternal subjects participated in the study | ||||||||
All Cause Mortality |
||||||||||||||||
| HIVposCD4LOW (Infants) | HIVposCD4HIGH (Infants) | HIVneg (Infants) | Total (Infants) | HIVposCD4LOW_Maternal Subjects | HIVposCD4HIGH_Maternal Subjects | HIVneg_Maternal Subjects | Total Maternal Subjects | |||||||||
| 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) | ||||||||
Serious Adverse Events |
||||||||||||||||
| HIVposCD4LOW (Infants) | HIVposCD4HIGH (Infants) | HIVneg (Infants) | Total (Infants) | HIVposCD4LOW_Maternal Subjects | HIVposCD4HIGH_Maternal Subjects | HIVneg_Maternal Subjects | Total Maternal Subjects | |||||||||
| 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 | 17/91 (18.7%) | 16/88 (18.2%) | 16/87 (18.4%) | 49/266 (18.4%) | 25/90 (27.8%) | 28/89 (31.5%) | 29/90 (32.2%) | 82/269 (30.5%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| ANAEMIA | 0/91 (0%) | 2/88 (2.3%) | 0/87 (0%) | 2/266 (0.8%) | 1/90 (1.1%) | 0/89 (0%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| DISSEMINATED INTRAVASCULAR COAGULATION | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 1/89 (1.1%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| HAEMORRHAGIC DISEASE OF NEWBORN | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| CARDIAC ARREST | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| CARDIAC DISORDER | 1/91 (1.1%) | 0/88 (0%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| Congenital, familial and genetic disorders | ||||||||||||||||
| CHROMOSOMAL DELETION | 1/91 (1.1%) | 0/88 (0%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| CONGENITAL PNEUMONIA | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| PATENT DUCTUS ARTERIOSUS | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| TALIPES | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| TRISOMY 21 | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| Eye disorders | ||||||||||||||||
| CONJUNCTIVAL HAEMORRHAGE | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| GASTRITIS | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 0/89 (0%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| INGUINAL HERNIA, OBSTRUCTIVE | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| UMBILICAL HERNIA | 1/91 (1.1%) | 0/88 (0%) | 1/87 (1.1%) | 2/266 (0.8%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| General disorders | ||||||||||||||||
| FEELING JITTERY | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| AMNIOTIC CAVITY INFECTION | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 0/89 (0%) | 1/90 (1.1%) | 2/269 (0.7%) | ||||||||
| BREAST ABSCESS | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| BRONCHOPNEUMONIA | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| CELLULITIS | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| ENDOMETRITIS | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 0/89 (0%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| GASTROENTERITIS | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| MALARIA | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 1/89 (1.1%) | 1/90 (1.1%) | 2/269 (0.7%) | ||||||||
| MENINGITIS | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| PNEUMONIA | 2/91 (2.2%) | 0/88 (0%) | 1/87 (1.1%) | 3/266 (1.1%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| POST PROCEDURAL SEPSIS | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 0/89 (0%) | 1/90 (1.1%) | 1/269 (0.4%) | ||||||||
| SEPSIS | 1/91 (1.1%) | 0/88 (0%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| SEPSIS NEONATAL | 3/91 (3.3%) | 5/88 (5.7%) | 3/87 (3.4%) | 11/266 (4.1%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| SYPHILIS | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 1/89 (1.1%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| URINARY TRACT INFECTION | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 1/89 (1.1%) | 0/90 (0%) | 2/269 (0.7%) | ||||||||
| VULVOVAGINAL CANDIDIASIS | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 1/89 (1.1%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| LACERATION | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| PERINEAL INJURY | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 0/89 (0%) | 1/90 (1.1%) | 2/269 (0.7%) | ||||||||
| UTERINE RUPTURE | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 1/89 (1.1%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| Investigations | ||||||||||||||||
| BLOOD PRESSURE INCREASED | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 0/89 (0%) | 1/90 (1.1%) | 1/269 (0.4%) | ||||||||
| HAEMOGLOBIN DECREASED | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 0/89 (0%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| DEHYDRATION | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| HYPERNATRAEMIA | 0/91 (0%) | 2/88 (2.3%) | 0/87 (0%) | 2/266 (0.8%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| METABOLIC ACIDOSIS | 0/91 (0%) | 1/88 (1.1%) | 1/87 (1.1%) | 2/266 (0.8%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| MUSCULAR WEAKNESS | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 1/89 (1.1%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| CONVULSION | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| EPILEPSY | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 1/89 (1.1%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| HYPOXIC-ISCHAEMIC ENCEPHALOPATHY | 1/91 (1.1%) | 0/88 (0%) | 3/87 (3.4%) | 4/266 (1.5%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| PARTIAL SEIZURES | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| VIITH NERVE PARALYSIS | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 0/89 (0%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||||||||
| BREECH PRESENTATION | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 0/89 (0%) | 1/90 (1.1%) | 2/269 (0.7%) | ||||||||
| CAPUT SUCCEDANEUM | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| CEPHALO-PELVIC DISPROPORTION | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 3/90 (3.3%) | 0/89 (0%) | 9/90 (10%) | 12/269 (4.5%) | ||||||||
| CERVIX DYSTOCIA | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 1/89 (1.1%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| ECLAMPSIA | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 0/89 (0%) | 1/90 (1.1%) | 1/269 (0.4%) | ||||||||
| FAILED INDUCTION OF LABOUR | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 2/89 (2.2%) | 0/90 (0%) | 2/269 (0.7%) | ||||||||
| FALSE LABOUR | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 1/89 (1.1%) | 0/90 (0%) | 2/269 (0.7%) | ||||||||
| FOETAL DISTRESS SYNDROME | 1/91 (1.1%) | 1/88 (1.1%) | 0/87 (0%) | 2/266 (0.8%) | 6/90 (6.7%) | 2/89 (2.2%) | 1/90 (1.1%) | 9/269 (3.3%) | ||||||||
| GESTATIONAL DIABETES | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 1/89 (1.1%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| GESTATIONAL HYPERTENSION | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 3/89 (3.4%) | 0/90 (0%) | 4/269 (1.5%) | ||||||||
| HAEMORRHAGE IN PREGNANCY | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 4/89 (4.5%) | 1/90 (1.1%) | 6/269 (2.2%) | ||||||||
| HYPEREMESIS GRAVIDARUM | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 0/89 (0%) | 1/90 (1.1%) | 1/269 (0.4%) | ||||||||
| JAUNDICE NEONATAL | 0/91 (0%) | 2/88 (2.3%) | 2/87 (2.3%) | 4/266 (1.5%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| LOW BIRTH WEIGHT BABY | 2/91 (2.2%) | 2/88 (2.3%) | 1/87 (1.1%) | 5/266 (1.9%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| POSTPARTUM HAEMORRHAGE | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 2/89 (2.2%) | 1/90 (1.1%) | 3/269 (1.1%) | ||||||||
| PRE-ECLAMPSIA | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 2/89 (2.2%) | 0/90 (0%) | 3/269 (1.1%) | ||||||||
| PREMATURE BABY | 5/91 (5.5%) | 3/88 (3.4%) | 3/87 (3.4%) | 11/266 (4.1%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| PREMATURE DELIVERY | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 2/90 (2.2%) | 3/89 (3.4%) | 1/90 (1.1%) | 6/269 (2.2%) | ||||||||
| PREMATURE LABOUR | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 2/90 (2.2%) | 3/89 (3.4%) | 2/90 (2.2%) | 7/269 (2.6%) | ||||||||
| PRETERM PREMATURE RUPTURE OF MEMBRANES | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 3/90 (3.3%) | 7/89 (7.9%) | 2/90 (2.2%) | 12/269 (4.5%) | ||||||||
| PROLONGED LABOUR | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 3/90 (3.3%) | 5/89 (5.6%) | 5/90 (5.6%) | 13/269 (4.8%) | ||||||||
| PROLONGED PREGNANCY | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 0/89 (0%) | 1/90 (1.1%) | 2/269 (0.7%) | ||||||||
| PROLONGED RUPTURE OF MEMBRANES | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 3/89 (3.4%) | 1/90 (1.1%) | 4/269 (1.5%) | ||||||||
| RETAINED PLACENTA OR MEMBRANES | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 1/89 (1.1%) | 0/90 (0%) | 2/269 (0.7%) | ||||||||
| RETAINED PRODUCTS OF CONCEPTION | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 0/89 (0%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| STILLBIRTH | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 1/89 (1.1%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| THREATENED LABOUR | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 2/90 (2.2%) | 1/89 (1.1%) | 0/90 (0%) | 3/269 (1.1%) | ||||||||
| TRANSVERSE PRESENTATION | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 1/90 (1.1%) | 0/89 (0%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| RENAL IMPAIRMENT | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| Reproductive system and breast disorders | ||||||||||||||||
| UTERINE CERVIX STENOSIS | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 1/89 (1.1%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| NEONATAL ASPHYXIA | 1/91 (1.1%) | 2/88 (2.3%) | 2/87 (2.3%) | 5/266 (1.9%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| NEONATAL ASPIRATION | 2/91 (2.2%) | 1/88 (1.1%) | 1/87 (1.1%) | 4/266 (1.5%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| NEONATAL RESPIRATORY DISTRESS SYNDROME | 5/91 (5.5%) | 2/88 (2.3%) | 0/87 (0%) | 7/266 (2.6%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| RESPIRATORY DISTRESS | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| TRANSIENT TACHYPNOEA OF THE NEWBORN | 2/91 (2.2%) | 1/88 (1.1%) | 0/87 (0%) | 3/266 (1.1%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| MELANOSIS | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| PETECHIAE | 1/91 (1.1%) | 0/88 (0%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| Surgical and medical procedures | ||||||||||||||||
| CAESAREAN SECTION | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 2/90 (2.2%) | 2/89 (2.2%) | 2/90 (2.2%) | 6/269 (2.2%) | ||||||||
| Vascular disorders | ||||||||||||||||
| HAEMATOMA | 1/91 (1.1%) | 0/88 (0%) | 1/87 (1.1%) | 2/266 (0.8%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| SHOCK | 0/91 (0%) | 1/88 (1.1%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| SHOCK HAEMORRHAGIC | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 0/90 (0%) | 1/89 (1.1%) | 0/90 (0%) | 1/269 (0.4%) | ||||||||
| SUBGALEAL HAEMATOMA | 1/91 (1.1%) | 0/88 (0%) | 0/87 (0%) | 1/266 (0.4%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| HIVposCD4LOW (Infants) | HIVposCD4HIGH (Infants) | HIVneg (Infants) | Total (Infants) | HIVposCD4LOW_Maternal Subjects | HIVposCD4HIGH_Maternal Subjects | HIVneg_Maternal Subjects | Total Maternal Subjects | |||||||||
| 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 | 13/91 (14.3%) | 11/88 (12.5%) | 7/87 (8%) | 31/266 (11.7%) | 55/90 (61.1%) | 68/89 (76.4%) | 71/90 (78.9%) | 194/269 (72.1%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| ABDOMINAL PAIN | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 2/90 (2.2%) | 3/89 (3.4%) | 5/90 (5.6%) | 10/269 (3.7%) | ||||||||
| DIARRHOEA | 0/91 (0%) | 0/88 (0%) | 1/87 (1.1%) | 1/266 (0.4%) | 1/90 (1.1%) | 0/89 (0%) | 7/90 (7.8%) | 8/269 (3%) | ||||||||
| NAUSEA | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 12/90 (13.3%) | 16/89 (18%) | 22/90 (24.4%) | 50/269 (18.6%) | ||||||||
| General disorders | ||||||||||||||||
| CHILLS | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 8/90 (8.9%) | 12/89 (13.5%) | 20/90 (22.2%) | 40/269 (14.9%) | ||||||||
| FATIGUE | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 21/90 (23.3%) | 27/89 (30.3%) | 42/90 (46.7%) | 90/269 (33.5%) | ||||||||
| INJECTION SITE PAIN | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 16/90 (17.8%) | 27/89 (30.3%) | 36/90 (40%) | 79/269 (29.4%) | ||||||||
| MALAISE | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 9/90 (10%) | 18/89 (20.2%) | 21/90 (23.3%) | 48/269 (17.8%) | ||||||||
| PAIN | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 3/90 (3.3%) | 3/89 (3.4%) | 5/90 (5.6%) | 11/269 (4.1%) | ||||||||
| Infections and infestations | ||||||||||||||||
| CONJUNCTIVITIS | 7/91 (7.7%) | 3/88 (3.4%) | 2/87 (2.3%) | 12/266 (4.5%) | 0/90 (0%) | 0/89 (0%) | 0/90 (0%) | 0/269 (0%) | ||||||||
| UPPER RESPIRATORY TRACT INFECTION | 10/91 (11%) | 6/88 (6.8%) | 3/87 (3.4%) | 19/266 (7.1%) | 9/90 (10%) | 9/89 (10.1%) | 1/90 (1.1%) | 19/269 (7.1%) | ||||||||
| URINARY TRACT INFECTION | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 6/90 (6.7%) | 5/89 (5.6%) | 1/90 (1.1%) | 12/269 (4.5%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| PERINEAL INJURY | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 17/90 (18.9%) | 24/89 (27%) | 21/90 (23.3%) | 62/269 (23%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| ARTHRALGIA | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 11/90 (12.2%) | 20/89 (22.5%) | 26/90 (28.9%) | 57/269 (21.2%) | ||||||||
| MYALGIA | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 7/90 (7.8%) | 15/89 (16.9%) | 21/90 (23.3%) | 43/269 (16%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| HEADACHE | 0/91 (0%) | 0/88 (0%) | 0/87 (0%) | 0/266 (0%) | 23/90 (25.6%) | 32/89 (36%) | 41/90 (45.6%) | 96/269 (35.7%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| COUGH | 1/91 (1.1%) | 2/88 (2.3%) | 1/87 (1.1%) | 4/266 (1.5%) | 3/90 (3.3%) | 2/89 (2.2%) | 5/90 (5.6%) | 10/269 (3.7%) | ||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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:
NCT01412801
Other Study ID Numbers:
- V98_05
First Posted:
Aug 9, 2011
Last Update Posted:
Sep 12, 2014
Last Verified:
Sep 1, 2014