Bacterial Infections, Gram-Positive Bacterial Infections, Streptococcal Infections
Conditions
Keywords
Group B streptococcus, GBS, Vaccine, Prevention of group B streptococcus infection
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.
Interventions
BIOLOGICALGroup B streptococcus vaccine
Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.
Sponsors
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 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. |
Countries
Malawi, South Africa
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| HIVposCD4LOW_Maternal 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 | 91 |
| HIVposCD4HIGH_Maternal 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 | 89 |
| HIVneg_Maternal 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 | 90 |
| HIVposCD4LOW (Infants) Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but \> 50 cells/µL | 91 |
| HIVposCD4HIGH (Infants) Infants born to HIV-antibody positive maternal subjects with CD4+ count \>350 cells/µL | 88 |
| HIVneg (Infants) Infants born to HIV-antibody negative maternal subjects | 87 |
| Total | 536 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 4 | 2 | 2 |
| Overall Study | Lost to Follow-up | 1 | 2 | 4 | 0 | 1 | 1 |
| Overall Study | Relocated to another area | 0 | 0 | 2 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | HIVposCD4LOW_Maternal | HIVposCD4HIGH_Maternal | HIVneg_Maternal | HIVposCD4LOW (Infants) | HIVposCD4HIGH (Infants) | HIVneg (Infants) |
|---|---|---|---|---|---|---|---|
| Age, Customized Infants | 1.6 days STANDARD_DEVIATION 1 | NA days | NA days | NA days | 4.1 days STANDARD_DEVIATION 1.6 | 6.7 days STANDARD_DEVIATION 2.5 | 1.3 days STANDARD_DEVIATION 1.1 |
| Age, Customized Maternal Subjects | 27.1 years STANDARD_DEVIATION 5 | 28.3 years STANDARD_DEVIATION 4.8 | 28.1 years STANDARD_DEVIATION 5.2 | 24.7 years STANDARD_DEVIATION 4.4 | NA years | NA years | NA years |
| Sex: Female, Male Female | 393 Participants | 91 Participants | 89 Participants | 90 Participants | 42 Participants | 40 Participants | 41 Participants |
| Sex: Female, Male Male | 143 Participants | 0 Participants | 0 Participants | 0 Participants | 49 Participants | 48 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 91 | 11 / 88 | 7 / 87 | 31 / 266 | 55 / 90 | 68 / 89 | 71 / 90 | 194 / 269 |
| serious Total, serious adverse events | 17 / 91 | 16 / 88 | 16 / 87 | 49 / 266 | 25 / 90 | 28 / 89 | 29 / 90 | 82 / 269 |
Outcome results
Primary
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.
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
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIVposCD4LOW_Maternal | 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. | Serotype Ib (41,54,57) | 0.51 Ratios |
| HIVposCD4LOW_Maternal | 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. | Serotype Ia | 0.58 Ratios |
| HIVposCD4LOW_Maternal | 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. | Serotype III (53,44,66) | 0.6 Ratios |
| HIVposCD4HIGH_Maternal | 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. | Serotype Ib (41,54,57) | 0.64 Ratios |
| HIVposCD4HIGH_Maternal | 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. | Serotype Ia | 0.6 Ratios |
| HIVposCD4HIGH_Maternal | 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. | Serotype III (53,44,66) | 0.51 Ratios |
| HIVneg_Maternal | 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. | Serotype Ia | 0.72 Ratios |
| HIVneg_Maternal | 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. | Serotype III (53,44,66) | 0.56 Ratios |
| HIVneg_Maternal | 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. | Serotype Ib (41,54,57) | 0.49 Ratios |
98.4% CI: [0.71, 1.3]
98.4% CI: [0.6, 1.09]
98.4% CI: [0.63, 1.14]
98.4% CI: [0.49, 1.29]
98.4% CI: [0.65, 1.69]
98.4% CI: [0.85, 2.06]
98.4% CI: [0.66, 2.07]
98.4% CI: [0.63, 1.78]
98.4% CI: [0.52, 1.58]
Primary
Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at 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.
Time frame: Day of delivery/birth
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIVposCD4LOW_Maternal | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ib(74, 80, 82, 44, 56, 57) | 1.84 μg/mL |
| HIVposCD4LOW_Maternal | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ia (83, 81, 83, 79, 81, 83) | 2.07 μg/mL |
| HIVposCD4LOW_Maternal | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes III (83, 72, 82, 54, 51, 66) | 1.07 μg/mL |
| HIVposCD4HIGH_Maternal | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ib(74, 80, 82, 44, 56, 57) | 2.4 μg/mL |
| HIVposCD4HIGH_Maternal | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ia (83, 81, 83, 79, 81, 83) | 2.31 μg/mL |
| HIVposCD4HIGH_Maternal | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes III (83, 72, 82, 54, 51, 66) | 1.03 μg/mL |
| HIVneg_Maternal | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes III (83, 72, 82, 54, 51, 66) | 3.61 μg/mL |
| HIVneg_Maternal | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ia (83, 81, 83, 79, 81, 83) | 3.98 μg/mL |
| HIVneg_Maternal | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ib(74, 80, 82, 44, 56, 57) | 4.08 μg/mL |
| HIVposCD4LOW(Infants) | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes III (83, 72, 82, 54, 51, 66) | 0.6 μg/mL |
| HIVposCD4LOW(Infants) | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ib(74, 80, 82, 44, 56, 57) | 1.31 μg/mL |
| HIVposCD4LOW(Infants) | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ia (83, 81, 83, 79, 81, 83) | 1.01 μg/mL |
| HIVposCD4HIGH(Infants) | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes III (83, 72, 82, 54, 51, 66) | 0.52 μg/mL |
| HIVposCD4HIGH(Infants) | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ib(74, 80, 82, 44, 56, 57) | 1.62 μg/mL |
| HIVposCD4HIGH(Infants) | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ia (83, 81, 83, 79, 81, 83) | 1.22 μg/mL |
| HIVneg(Infants) | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ia (83, 81, 83, 79, 81, 83) | 3.91 μg/mL |
| HIVneg(Infants) | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes Ib(74, 80, 82, 44, 56, 57) | 2.67 μg/mL |
| HIVneg(Infants) | Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth | GBS serotypes III (83, 72, 82, 54, 51, 66) | 3.88 μg/mL |
Secondary
Percentages of Infants Who Experienced Unsolicited Adverse Events
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
Population: Safety Set (Unsolicited AEs, Infants)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIVposCD4LOW_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Any AE | 41 percentages of Infant subjects |
| HIVposCD4LOW_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Possibly related AE | 0 percentages of Infant subjects |
| HIVposCD4LOW_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | SAE | 19 percentages of Infant subjects |
| HIVposCD4LOW_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | AE leading to withdrawal from study | 4 percentages of Infant subjects |
| HIVposCD4LOW_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Medically attended AEs | 23 percentages of Infant subjects |
| HIVposCD4LOW_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Death | 4 percentages of Infant subjects |
| HIVposCD4LOW_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Possibly related SAE | 0 percentages of Infant subjects |
| HIVposCD4HIGH_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | SAE | 18 percentages of Infant subjects |
| HIVposCD4HIGH_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Possibly related SAE | 0 percentages of Infant subjects |
| HIVposCD4HIGH_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | AE leading to withdrawal from study | 2 percentages of Infant subjects |
| HIVposCD4HIGH_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Death | 2 percentages of Infant subjects |
| HIVposCD4HIGH_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Any AE | 49 percentages of Infant subjects |
| HIVposCD4HIGH_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Medically attended AEs | 33 percentages of Infant subjects |
| HIVposCD4HIGH_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Possibly related AE | 2 percentages of Infant subjects |
| HIVneg_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Possibly related AE | 1 percentages of Infant subjects |
| HIVneg_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | SAE | 18 percentages of Infant subjects |
| HIVneg_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Medically attended AEs | 24 percentages of Infant subjects |
| HIVneg_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Possibly related SAE | 0 percentages of Infant subjects |
| HIVneg_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Death | 2 percentages of Infant subjects |
| HIVneg_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | Any AE | 43 percentages of Infant subjects |
| HIVneg_Maternal | Percentages of Infants Who Experienced Unsolicited Adverse Events | AE leading to withdrawal from study | 2 percentages of Infant subjects |
Secondary
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
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
Population: FAS (Maternal Subjects)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIVposCD4LOW_Maternal | 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 | ≥ 0.5 µg/mL(Serotype Ib) | 83 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 3 µg/mL(Serotype Ia) | 40 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 0.5 µg/mL(Serotype III) | 63 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 1 µg/mL(Serotype Ib) | 65 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 0.5 µg/mL(Serotype Ia) | 67 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 0.2 µg/mL(Serotype III) | 82 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 2 µg/mL(Serotype Ib) | 40 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 0.1 µg/mL(Serotype III) | 96 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 3 µg/mL(Serotype Ib) | 28 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 8 µg/mL(Serotype III) | 17 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 8 µg/mL(Serotype Ib) | 13 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 5 µg/mL(Serotype Ib) | 20 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 5 µg/mL(Serotype Ia) | 30 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 0.2 µg/mL(Serotype Ib) | 88 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 5 µg/mL(Serotype III) | 18 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 8 µg/mL(Serotype Ia) | 22 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 2 µg/mL(Serotype Ia) | 51 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 3 µg/mL(Serotype III) | 29 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 0.1 µg/mL(Serotype Ib) | 89 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 1 µg/mL(Serotype Ia) | 55 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 2 µg/mL(Serotype III) | 36 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 0.2 µg/mL(Serotype Ia) | 100 Percentage of maternal subjects |
| HIVposCD4LOW_Maternal | 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 | ≥ 1 µg/mL(Serotype III) | 47 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 0.2 µg/mL(Serotype III) | 76 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 0.5 µg/mL(Serotype Ia) | 71 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 1 µg/mL(Serotype Ia) | 59 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 2 µg/mL(Serotype Ia) | 49 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 3 µg/mL(Serotype Ia) | 46 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 5 µg/mL(Serotype Ia) | 41 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 8 µg/mL(Serotype Ia) | 30 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 0.1 µg/mL(Serotype Ib) | 98 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 0.2 µg/mL(Serotype Ib) | 98 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 0.5 µg/mL(Serotype Ib) | 84 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 1 µg/mL(Serotype Ib) | 63 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 3 µg/mL(Serotype Ib) | 35 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 5 µg/mL(Serotype Ib) | 26 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 8 µg/mL(Serotype Ib) | 17 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 0.1 µg/mL(Serotype III) | 80 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 0.5 µg/mL(Serotype III) | 51 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 1 µg/mL(Serotype III) | 41 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 2 µg/mL(Serotype III) | 24 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 3 µg/mL(Serotype III) | 18 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 5 µg/mL(Serotype III) | 13 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 8 µg/mL(Serotype III) | 12 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 0.2 µg/mL(Serotype Ia) | 99 Percentage of maternal subjects |
| HIVposCD4HIGH_Maternal | 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 | ≥ 2 µg/mL(Serotype Ib) | 41 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 1 µg/mL(Serotype Ia) | 71 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 0.5 µg/mL(Serotype III) | 86 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 0.2 µg/mL(Serotype Ib) | 98 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 8 µg/mL(Serotype III) | 40 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 1 µg/mL(Serotype III) | 73 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 0.1 µg/mL(Serotype Ib) | 98 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 2 µg/mL(Serotype Ia) | 60 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 2 µg/mL(Serotype III) | 64 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 8 µg/mL(Serotype Ia) | 47 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 0.5 µg/mL(Serotype Ia) | 82 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 3 µg/mL(Serotype III) | 54 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 5 µg/mL(Serotype Ia) | 53 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 0.2 µg/mL(Serotype Ia) | 100 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 5 µg/mL(Serotype Ib) | 28 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 3 µg/mL(Serotype Ib) | 40 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 5 µg/mL(Serotype III) | 49 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 8 µg/mL(Serotype Ib) | 24 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 2 µg/mL(Serotype Ib) | 47 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 3 µg/mL(Serotype Ia) | 54 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 0.1 µg/mL(Serotype III) | 95 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 1 µg/mL(Serotype Ib) | 69 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 0.2 µg/mL(Serotype III) | 89 Percentage of maternal subjects |
| HIVneg_Maternal | 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 | ≥ 0.5 µg/mL(Serotype Ib) | 90 Percentage of maternal subjects |
Secondary
Percentages of Subjects Who Experienced Unsolicited Adverse Events
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
Population: Safety Set (Unsolicited AEs, Maternal Subjects)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIVposCD4LOW_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Possibly related AE | 7 percentages of subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | AE leading to withdrawal from study | 0 percentages of subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Possibly related SAE | 0 percentages of subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Any AE | 74 percentages of subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Death | 0 percentages of subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Medically attended AEs | 47 percentages of subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | SAE | 28 percentages of subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Possibly related SAE | 0 percentages of subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Any AE | 76 percentages of subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Possibly related AE | 13 percentages of subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | SAE | 31 percentages of subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | AE leading to withdrawal from study | 1 percentages of subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Medically attended AEs | 49 percentages of subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Death | 1 percentages of subjects |
| HIVneg_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | AE leading to withdrawal from study | 0 percentages of subjects |
| HIVneg_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Possibly related AE | 23 percentages of subjects |
| HIVneg_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Death | 0 percentages of subjects |
| HIVneg_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Medically attended AEs | 54 percentages of subjects |
| HIVneg_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Possibly related SAE | 0 percentages of subjects |
| HIVneg_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | SAE | 32 percentages of subjects |
| HIVneg_Maternal | Percentages of Subjects Who Experienced Unsolicited Adverse Events | Any AE | 78 percentages of subjects |
Secondary
Percentages of Subjects With Solicited Local Adverse Events (AEs)
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
Population: Safety Set (Solicited AEs, Maternal Subjects)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Ecchymosis(87, 88, 90) | 0 percentage of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Erythema(87, 88, 89) | 0 percentage of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Induration(87, 88, 90) | 0 percentage of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Swelling(87, 88, 90) | 0 percentage of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Pain(87, 88, 90) | 18 percentage of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Swelling(87, 88, 90) | 0 percentage of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Pain(87, 88, 90) | 30 percentage of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Erythema(87, 88, 89) | 1 percentage of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Ecchymosis(87, 88, 90) | 0 percentage of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Induration(87, 88, 90) | 1 percentage of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Pain(87, 88, 90) | 39 percentage of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Induration(87, 88, 90) | 0 percentage of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Swelling(87, 88, 90) | 2 percentage of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Ecchymosis(87, 88, 90) | 1 percentage of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Local Adverse Events (AEs) | Erythema(87, 88, 89) | 1 percentage of Subjects |
Secondary
Percentages of Subjects With Solicited Systemic AEs
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
Population: Safety Set (Solicited AEs, Maternal Subjects)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Arthralgia(87,88,90) | 13 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Chills(87,88,90) | 9 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Nausea(87,88,89) | 13 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Malaise(87,88,90) | 10 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Myalgia(87,88,90) | 8 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(≥ 40°C)(87, 88,90) | 0 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Headache(87,88,90) | 24 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Fatigue(87,88,90) | 24 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Fever ( ≥ 38°C)(87, 88, 90) | 3 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(<38°C)(87, 88,90) | 97 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(38-38.4°C)(87, 88,90) | 1 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(38.5-38.9°C)(87, 88,90) | 1 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(39-39.4°C)(87, 88,90) | 0 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(39.5-39.9°C)(87, 88,90) | 1 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Analgesic antipyr. meds(Other indicators) | 7 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Stayed home(Other indicators) | 3 percentages of Subjects |
| HIVposCD4LOW_Maternal | Percentages of Subjects With Solicited Systemic AEs | Rash(87,88,90) | 3 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Headache(87,88,90) | 32 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Fatigue(87,88,90) | 31 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Rash(87,88,90) | 1 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Fever ( ≥ 38°C)(87, 88, 90) | 0 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Analgesic antipyr. meds(Other indicators) | 10 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(<38°C)(87, 88,90) | 100 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(38-38.4°C)(87, 88,90) | 0 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(38.5-38.9°C)(87, 88,90) | 0 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Stayed home(Other indicators) | 5 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(39-39.4°C)(87, 88,90) | 0 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Chills(87,88,90) | 14 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Nausea(87,88,89) | 17 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Malaise(87,88,90) | 19 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(39.5-39.9°C)(87, 88,90) | 0 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Myalgia(87,88,90) | 17 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Arthralgia(87,88,90) | 23 percentages of Subjects |
| HIVposCD4HIGH_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(≥ 40°C)(87, 88,90) | 0 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Malaise(87,88,90) | 23 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(≥ 40°C)(87, 88,90) | 0 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Headache(87,88,90) | 43 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Arthralgia(87,88,90) | 29 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Rash(87,88,90) | 1 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Chills(87,88,90) | 22 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(39-39.4°C)(87, 88,90) | 0 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Fever ( ≥ 38°C)(87, 88, 90) | 0 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Myalgia(87,88,90) | 23 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Nausea(87,88,89) | 22 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(<38°C)(87, 88,90) | 100 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Analgesic antipyr. meds(Other indicators) | 9 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Stayed home(Other indicators) | 9 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(38-38.4°C)(87, 88,90) | 0 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Fatigue(87,88,90) | 47 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(39.5-39.9°C)(87, 88,90) | 0 percentages of Subjects |
| HIVneg_Maternal | Percentages of Subjects With Solicited Systemic AEs | Temperature(38.5-38.9°C)(87, 88,90) | 0 percentages of Subjects |
Secondary
Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at 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.
Time frame: Day 1, 15, 31 and at Delivery
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib At delivery | 2.12 µg/mL |
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib Day 1 | 0.51 µg/mL |
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III At delivery | 1.25 µg/mL |
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib Day 31 | 2.62 µg/mL |
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib Day 15 | 2.93 µg/mL |
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III Day 15 | 1.24 µg/mL |
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia Day 15 | 2.62 µg/mL |
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia Day 31 | 2.68 µg/mL |
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III Day 31 | 1.51 µg/mL |
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III Day 1 | 0.12 µg/mL |
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia At delivery | 2.22 µg/mL |
| HIVposCD4LOW_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia Day 1 | 0.24 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia Day 15 | 2.95 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia Day 1 | 0.25 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia Day 31 | 3.26 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia At delivery | 2.69 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib Day 1 | 0.36 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib Day 15 | 3.5 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib Day 31 | 3.68 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib At delivery | 3.04 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III Day 1 | 0.099 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III Day 15 | 1.52 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III Day 31 | 1.31 µg/mL |
| HIVposCD4HIGH_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III At delivery | 1.07 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib At delivery | 3.84 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia Day 31 | 6.63 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia Day 15 | 5.61 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III Day 1 | 0.14 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia Day 1 | 0.38 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III Day 31 | 5.35 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib Day 15 | 6.07 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib Day 1 | 0.4 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III Day 15 | 5.9 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ib Day 31 | 5.35 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype Ia At delivery | 4.49 µg/mL |
| HIVneg_Maternal | Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery | Serotype III At delivery | 3.8 µg/mL |