ClinicalTrials.gov
ClinicalTrials.gov Menu

Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01412801
Recruitment Status : Completed
First Posted : August 9, 2011
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Intervention Biological: Group B streptococcus vaccine
Enrollment 270
Recruitment Details Subjects were enrolled at Malawi and South Africa
Pre-assignment Details 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)
Hide 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
Reason Not Completed
Death             0             1             0             4             2             2
Lost to Follow-up             1             2             4             0             1             1
Withdrawal by Subject             3             2             1             0             0             0
Relocated to another area             0             0             2             0             0             0
Arm/Group Title HIVposCD4LOW_Maternal HIVposCD4HIGH_Maternal HIVneg_Maternal HIVposCD4LOW (Infants) HIVposCD4HIGH (Infants) HIVneg (Infants) Total
Hide 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 Number of Baseline Participants 91 89 90 91 88 87 536
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Maternal Subjects Number Analyzed 91 participants 89 participants 90 participants 91 participants 88 participants 87 participants 536 participants
28.3  (4.8) 28.1  (5.2) 24.7  (4.4) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 27.1  (5.0)
[1]
"Mothers' ages only provided Here"
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Days
Infants Number Analyzed 91 participants 89 participants 90 participants 91 participants 88 participants 87 participants 536 participants
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 4.1  (1.6) 6.7  (2.5) 1.3  (1.1) 1.6  (1.0)
[1]
"Infants' ages only provided here"
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 89 participants 90 participants 91 participants 88 participants 87 participants 536 participants
Female
91
 100.0%
89
 100.0%
90
 100.0%
42
  46.2%
40
  45.5%
41
  47.1%
393
  73.3%
Male
0
   0.0%
0
   0.0%
0
   0.0%
49
  53.8%
48
  54.5%
46
  52.9%
143
  26.7%
1.Primary Outcome
Title Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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)
Hide 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
Overall Number of Participants Analyzed 83 81 83 83 81 83
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
GBS serotypes Ia (83, 81, 83, 79, 81, 83)
2.07
(1.44 to 2.98)
2.31
(1.6 to 3.34)
3.98
(2.75 to 5.74)
1.01
(0.66 to 1.56)
1.22
(0.8 to 1.87)
3.91
(2.56 to 5.96)
GBS serotypes Ib(74, 80, 82, 44, 56, 57)
1.84
(1.22 to 2.77)
2.4
(1.64 to 3.52)
4.08
(2.85 to 5.83)
1.31
(0.78 to 2.19)
1.62
(1.03 to 2.56)
2.67
(1.7 to 4.2)
GBS serotypes III (83, 72, 82, 54, 51, 66)
1.07
(0.71 to 1.6)
1.03
(0.69 to 1.53)
3.61
(2.51 to 5.18)
0.6
(0.36 to 0.99)
0.52
(0.31 to 0.88)
3.88
(2.47 to 6.1)
2.Primary Outcome
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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 79 79 83
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratios
Serotype Ia
0.58
(0.49 to 0.69)
0.6
(0.51 to 0.72)
0.72
(0.61 to 0.85)
Serotype Ib (41,54,57)
0.51
(0.38 to 0.69)
0.64
(0.5 to 0.83)
0.49
(0.38 to 0.63)
Serotype III (53,44,66)
0.6
(0.44 to 0.82)
0.51
(0.36 to 0.72)
0.56
(0.43 to 0.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIVposCD4LOW, HIVposCD4HIGH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HIVposCD4LOW, HIVneg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection HIVposCD4HIGH, HIVneg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection HIVposCD4LOW, HIVposCD4HIGH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection HIVposCD4LOW, HIVneg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection HIVposCD4HIGH, HIVneg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection HIVposCD4LOW, HIVposCD4HIGH
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection HIVposCD4LOW, HIVneg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection HIVposCD4HIGH, HIVneg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
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
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 74 75 77
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Serotype Ia Day 1
0.24
(0.19 to 0.3)
0.25
(0.2 to 0.32)
0.38
(0.3 to 0.48)
Serotype Ia Day 15
2.62
(1.64 to 4.17)
2.95
(1.86 to 4.69)
5.61
(3.56 to 8.84)
Serotype Ia Day 31
2.68
(1.75 to 4.1)
3.26
(2.14 to 4.98)
6.63
(4.37 to 10)
Serotype Ia At delivery
2.22
(1.5 to 3.29)
2.69
(1.82 to 3.98)
4.49
(3.06 to 6.6)
Serotype Ib Day 1
0.51
(0.38 to 0.7)
0.36
(0.27 to 0.48)
0.4
(0.31 to 0.51)
Serotype Ib Day 15
2.93
(1.73 to 4.95)
3.5
(2.17 to 5.65)
6.07
(3.98 to 9.26)
Serotype Ib Day 31
2.62
(1.62 to 4.24)
3.68
(2.38 to 5.7)
5.35
(3.63 to 7.87)
Serotype Ib At delivery
2.12
(1.36 to 3.31)
3.04
(2.03 to 4.56)
3.84
(2.69 to 5.5)
Serotype III Day 1
0.12
(0.086 to 0.17)
0.099
(0.072 to 0.14)
0.14
(0.1 to 0.18)
Serotype III Day 15
1.24
(0.79 to 1.95)
1.52
(0.97 to 2.36)
5.9
(3.99 to 8.72)
Serotype III Day 31
1.51
(0.97 to 2.35)
1.31
(0.85 to 2.02)
5.35
(3.66 to 7.83)
Serotype III At delivery
1.25
(0.81 to 1.94)
1.07
(0.7 to 1.65)
3.8
(2.61 to 5.55)
4.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS (Maternal Subjects)
Arm/Group Title HIVposCD4LOW_Maternal HIVposCD4HIGH_Maternal HIVneg_Maternal
Hide 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.
Overall Number of Participants Analyzed 83 82 83
Measure Type: Number
Unit of Measure: Percentage of maternal subjects
≥ 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
5.Secondary Outcome
Title Percentages of Subjects With Solicited Local Adverse Events (AEs)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set (Solicited AEs, Maternal Subjects)
Arm/Group Title HIVposCD4LOW_Maternal HIVposCD4HIGH_Maternal HIVneg_Maternal
Hide 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
Overall Number of Participants Analyzed 88 88 90
Measure Type: Number
Unit of Measure: percentage of Subjects
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
6.Secondary Outcome
Title Percentages of Subjects With Solicited Systemic AEs
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set (Solicited AEs, Maternal Subjects)
Arm/Group Title HIVposCD4LOW_Maternal HIVposCD4HIGH_Maternal HIVneg_Maternal
Hide 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
Overall Number of Participants Analyzed 88 88 90
Measure Type: Number
Unit of Measure: percentages of Subjects
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
7.Secondary Outcome
Title Percentages of Subjects Who Experienced Unsolicited Adverse Events
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set (Unsolicited AEs, Maternal Subjects)
Arm/Group Title HIVposCD4LOW_Maternal HIVposCD4HIGH_Maternal HIVneg_Maternal
Hide 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
Overall Number of Participants Analyzed 90 89 90
Measure Type: Number
Unit of Measure: percentages of subjects
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
8.Secondary Outcome
Title Percentages of Infants Who Experienced Unsolicited Adverse Events
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Set (Unsolicited AEs, Infants)
Arm/Group Title HIVposCD4LOW (Infants) HIVposCD4HIGH (Infants) HIVneg (Infants)
Hide 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
Overall Number of Participants Analyzed 91 88 87
Measure Type: Number
Unit of Measure: percentages of Infant subjects
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
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
HIVposCD4LOW (Infants) HIVposCD4HIGH (Infants) HIVneg (Infants) Total (Infants) HIVposCD4LOW_Maternal Subjects HIVposCD4HIGH_Maternal Subjects HIVneg_Maternal Subjects Total Maternal Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/91 (18.68%)   16/88 (18.18%)   16/87 (18.39%)   49/266 (18.42%)   25/90 (27.78%)   28/89 (31.46%)   29/90 (32.22%)   82/269 (30.48%) 
Blood and lymphatic system disorders                 
ANAEMIA *  0/91 (0.00%)  2/88 (2.27%)  0/87 (0.00%)  2/266 (0.75%)  1/90 (1.11%)  0/89 (0.00%)  0/90 (0.00%)  1/269 (0.37%) 
DISSEMINATED INTRAVASCULAR COAGULATION *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  1/89 (1.12%)  0/90 (0.00%)  1/269 (0.37%) 
HAEMORRHAGIC DISEASE OF NEWBORN *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
Cardiac disorders                 
CARDIAC ARREST *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
CARDIAC DISORDER *  1/91 (1.10%)  0/88 (0.00%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
Congenital, familial and genetic disorders                 
CHROMOSOMAL DELETION *  1/91 (1.10%)  0/88 (0.00%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
CONGENITAL PNEUMONIA *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
PATENT DUCTUS ARTERIOSUS *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
TALIPES *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
TRISOMY 21 *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
Eye disorders                 
CONJUNCTIVAL HAEMORRHAGE *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
Gastrointestinal disorders                 
GASTRITIS *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  0/89 (0.00%)  0/90 (0.00%)  1/269 (0.37%) 
INGUINAL HERNIA, OBSTRUCTIVE *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
UMBILICAL HERNIA *  1/91 (1.10%)  0/88 (0.00%)  1/87 (1.15%)  2/266 (0.75%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
General disorders                 
FEELING JITTERY *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
Infections and infestations                 
AMNIOTIC CAVITY INFECTION *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  0/89 (0.00%)  1/90 (1.11%)  2/269 (0.74%) 
BREAST ABSCESS *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
BRONCHOPNEUMONIA *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
CELLULITIS *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
ENDOMETRITIS *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  0/89 (0.00%)  0/90 (0.00%)  1/269 (0.37%) 
GASTROENTERITIS *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
MALARIA *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  1/89 (1.12%)  1/90 (1.11%)  2/269 (0.74%) 
MENINGITIS *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
PNEUMONIA *  2/91 (2.20%)  0/88 (0.00%)  1/87 (1.15%)  3/266 (1.13%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
POST PROCEDURAL SEPSIS *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  0/89 (0.00%)  1/90 (1.11%)  1/269 (0.37%) 
SEPSIS *  1/91 (1.10%)  0/88 (0.00%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
SEPSIS NEONATAL *  3/91 (3.30%)  5/88 (5.68%)  3/87 (3.45%)  11/266 (4.14%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
SYPHILIS *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  1/89 (1.12%)  0/90 (0.00%)  1/269 (0.37%) 
URINARY TRACT INFECTION *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  1/89 (1.12%)  0/90 (0.00%)  2/269 (0.74%) 
VULVOVAGINAL CANDIDIASIS *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  1/89 (1.12%)  0/90 (0.00%)  1/269 (0.37%) 
Injury, poisoning and procedural complications                 
LACERATION *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
PERINEAL INJURY *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  0/89 (0.00%)  1/90 (1.11%)  2/269 (0.74%) 
UTERINE RUPTURE *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  1/89 (1.12%)  0/90 (0.00%)  1/269 (0.37%) 
Investigations                 
BLOOD PRESSURE INCREASED *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  0/89 (0.00%)  1/90 (1.11%)  1/269 (0.37%) 
HAEMOGLOBIN DECREASED *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  0/89 (0.00%)  0/90 (0.00%)  1/269 (0.37%) 
Metabolism and nutrition disorders                 
DEHYDRATION *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
HYPERNATRAEMIA *  0/91 (0.00%)  2/88 (2.27%)  0/87 (0.00%)  2/266 (0.75%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
METABOLIC ACIDOSIS *  0/91 (0.00%)  1/88 (1.14%)  1/87 (1.15%)  2/266 (0.75%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
Musculoskeletal and connective tissue disorders                 
MUSCULAR WEAKNESS *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  1/89 (1.12%)  0/90 (0.00%)  1/269 (0.37%) 
Nervous system disorders                 
CONVULSION *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
EPILEPSY *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  1/89 (1.12%)  0/90 (0.00%)  1/269 (0.37%) 
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY *  1/91 (1.10%)  0/88 (0.00%)  3/87 (3.45%)  4/266 (1.50%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
PARTIAL SEIZURES *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
VIITH NERVE PARALYSIS *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  0/89 (0.00%)  0/90 (0.00%)  1/269 (0.37%) 
Pregnancy, puerperium and perinatal conditions                 
BREECH PRESENTATION *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  0/89 (0.00%)  1/90 (1.11%)  2/269 (0.74%) 
CAPUT SUCCEDANEUM *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
CEPHALO-PELVIC DISPROPORTION *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  3/90 (3.33%)  0/89 (0.00%)  9/90 (10.00%)  12/269 (4.46%) 
CERVIX DYSTOCIA *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  1/89 (1.12%)  0/90 (0.00%)  1/269 (0.37%) 
ECLAMPSIA *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  0/89 (0.00%)  1/90 (1.11%)  1/269 (0.37%) 
FAILED INDUCTION OF LABOUR *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  2/89 (2.25%)  0/90 (0.00%)  2/269 (0.74%) 
FALSE LABOUR *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  1/89 (1.12%)  0/90 (0.00%)  2/269 (0.74%) 
FOETAL DISTRESS SYNDROME *  1/91 (1.10%)  1/88 (1.14%)  0/87 (0.00%)  2/266 (0.75%)  6/90 (6.67%)  2/89 (2.25%)  1/90 (1.11%)  9/269 (3.35%) 
GESTATIONAL DIABETES *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  1/89 (1.12%)  0/90 (0.00%)  1/269 (0.37%) 
GESTATIONAL HYPERTENSION *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  3/89 (3.37%)  0/90 (0.00%)  4/269 (1.49%) 
HAEMORRHAGE IN PREGNANCY *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  4/89 (4.49%)  1/90 (1.11%)  6/269 (2.23%) 
HYPEREMESIS GRAVIDARUM *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  0/89 (0.00%)  1/90 (1.11%)  1/269 (0.37%) 
JAUNDICE NEONATAL *  0/91 (0.00%)  2/88 (2.27%)  2/87 (2.30%)  4/266 (1.50%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
LOW BIRTH WEIGHT BABY *  2/91 (2.20%)  2/88 (2.27%)  1/87 (1.15%)  5/266 (1.88%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
POSTPARTUM HAEMORRHAGE *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  2/89 (2.25%)  1/90 (1.11%)  3/269 (1.12%) 
PRE-ECLAMPSIA *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  2/89 (2.25%)  0/90 (0.00%)  3/269 (1.12%) 
PREMATURE BABY *  5/91 (5.49%)  3/88 (3.41%)  3/87 (3.45%)  11/266 (4.14%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
PREMATURE DELIVERY *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  2/90 (2.22%)  3/89 (3.37%)  1/90 (1.11%)  6/269 (2.23%) 
PREMATURE LABOUR *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  2/90 (2.22%)  3/89 (3.37%)  2/90 (2.22%)  7/269 (2.60%) 
PRETERM PREMATURE RUPTURE OF MEMBRANES *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  3/90 (3.33%)  7/89 (7.87%)  2/90 (2.22%)  12/269 (4.46%) 
PROLONGED LABOUR *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  3/90 (3.33%)  5/89 (5.62%)  5/90 (5.56%)  13/269 (4.83%) 
PROLONGED PREGNANCY *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  0/89 (0.00%)  1/90 (1.11%)  2/269 (0.74%) 
PROLONGED RUPTURE OF MEMBRANES *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  3/89 (3.37%)  1/90 (1.11%)  4/269 (1.49%) 
RETAINED PLACENTA OR MEMBRANES *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  1/89 (1.12%)  0/90 (0.00%)  2/269 (0.74%) 
RETAINED PRODUCTS OF CONCEPTION *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  0/89 (0.00%)  0/90 (0.00%)  1/269 (0.37%) 
STILLBIRTH *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  1/89 (1.12%)  0/90 (0.00%)  1/269 (0.37%) 
THREATENED LABOUR *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  2/90 (2.22%)  1/89 (1.12%)  0/90 (0.00%)  3/269 (1.12%) 
TRANSVERSE PRESENTATION *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  1/90 (1.11%)  0/89 (0.00%)  0/90 (0.00%)  1/269 (0.37%) 
Renal and urinary disorders                 
RENAL IMPAIRMENT *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
Reproductive system and breast disorders                 
UTERINE CERVIX STENOSIS *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  1/89 (1.12%)  0/90 (0.00%)  1/269 (0.37%) 
Respiratory, thoracic and mediastinal disorders                 
NEONATAL ASPHYXIA *  1/91 (1.10%)  2/88 (2.27%)  2/87 (2.30%)  5/266 (1.88%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
NEONATAL ASPIRATION *  2/91 (2.20%)  1/88 (1.14%)  1/87 (1.15%)  4/266 (1.50%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
NEONATAL RESPIRATORY DISTRESS SYNDROME *  5/91 (5.49%)  2/88 (2.27%)  0/87 (0.00%)  7/266 (2.63%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
RESPIRATORY DISTRESS *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
TRANSIENT TACHYPNOEA OF THE NEWBORN *  2/91 (2.20%)  1/88 (1.14%)  0/87 (0.00%)  3/266 (1.13%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
Skin and subcutaneous tissue disorders                 
MELANOSIS *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
PETECHIAE *  1/91 (1.10%)  0/88 (0.00%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
Surgical and medical procedures                 
CAESAREAN SECTION *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  2/90 (2.22%)  2/89 (2.25%)  2/90 (2.22%)  6/269 (2.23%) 
Vascular disorders                 
HAEMATOMA *  1/91 (1.10%)  0/88 (0.00%)  1/87 (1.15%)  2/266 (0.75%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
SHOCK *  0/91 (0.00%)  1/88 (1.14%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
SHOCK HAEMORRHAGIC *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  0/90 (0.00%)  1/89 (1.12%)  0/90 (0.00%)  1/269 (0.37%) 
SUBGALEAL HAEMATOMA *  1/91 (1.10%)  0/88 (0.00%)  0/87 (0.00%)  1/266 (0.38%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
HIVposCD4LOW (Infants) HIVposCD4HIGH (Infants) HIVneg (Infants) Total (Infants) HIVposCD4LOW_Maternal Subjects HIVposCD4HIGH_Maternal Subjects HIVneg_Maternal Subjects Total Maternal Subjects
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/91 (14.29%)   11/88 (12.50%)   7/87 (8.05%)   31/266 (11.65%)   55/90 (61.11%)   68/89 (76.40%)   71/90 (78.89%)   194/269 (72.12%) 
Gastrointestinal disorders                 
ABDOMINAL PAIN *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  2/90 (2.22%)  3/89 (3.37%)  5/90 (5.56%)  10/269 (3.72%) 
DIARRHOEA *  0/91 (0.00%)  0/88 (0.00%)  1/87 (1.15%)  1/266 (0.38%)  1/90 (1.11%)  0/89 (0.00%)  7/90 (7.78%)  8/269 (2.97%) 
NAUSEA   0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  12/90 (13.33%)  16/89 (17.98%)  22/90 (24.44%)  50/269 (18.59%) 
General disorders                 
CHILLS   0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  8/90 (8.89%)  12/89 (13.48%)  20/90 (22.22%)  40/269 (14.87%) 
FATIGUE   0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  21/90 (23.33%)  27/89 (30.34%)  42/90 (46.67%)  90/269 (33.46%) 
INJECTION SITE PAIN *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  16/90 (17.78%)  27/89 (30.34%)  36/90 (40.00%)  79/269 (29.37%) 
MALAISE   0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  9/90 (10.00%)  18/89 (20.22%)  21/90 (23.33%)  48/269 (17.84%) 
PAIN *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  3/90 (3.33%)  3/89 (3.37%)  5/90 (5.56%)  11/269 (4.09%) 
Infections and infestations                 
CONJUNCTIVITIS *  7/91 (7.69%)  3/88 (3.41%)  2/87 (2.30%)  12/266 (4.51%)  0/90 (0.00%)  0/89 (0.00%)  0/90 (0.00%)  0/269 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION *  10/91 (10.99%)  6/88 (6.82%)  3/87 (3.45%)  19/266 (7.14%)  9/90 (10.00%)  9/89 (10.11%)  1/90 (1.11%)  19/269 (7.06%) 
URINARY TRACT INFECTION *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  6/90 (6.67%)  5/89 (5.62%)  1/90 (1.11%)  12/269 (4.46%) 
Injury, poisoning and procedural complications                 
PERINEAL INJURY *  0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  17/90 (18.89%)  24/89 (26.97%)  21/90 (23.33%)  62/269 (23.05%) 
Musculoskeletal and connective tissue disorders                 
ARTHRALGIA   0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  11/90 (12.22%)  20/89 (22.47%)  26/90 (28.89%)  57/269 (21.19%) 
MYALGIA   0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  7/90 (7.78%)  15/89 (16.85%)  21/90 (23.33%)  43/269 (15.99%) 
Nervous system disorders                 
HEADACHE   0/91 (0.00%)  0/88 (0.00%)  0/87 (0.00%)  0/266 (0.00%)  23/90 (25.56%)  32/89 (35.96%)  41/90 (45.56%)  96/269 (35.69%) 
Respiratory, thoracic and mediastinal disorders                 
COUGH *  1/91 (1.10%)  2/88 (2.27%)  1/87 (1.15%)  4/266 (1.50%)  3/90 (3.33%)  2/89 (2.25%)  5/90 (5.56%)  10/269 (3.72%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01412801     History of Changes
Other Study ID Numbers: V98_05
First Submitted: August 8, 2011
First Posted: August 9, 2011
Results First Submitted: June 20, 2014
Results First Posted: September 12, 2014
Last Update Posted: September 12, 2014