Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Mother Exploratory outcome 1 - Ratio Placental transfer ratio of GBS-specific antibodies in HIV-exposed and unexposed pregnancies. |
1. Fold increase in GBS serotype specific IgG antibody titres over baseline measured before vaccination through 12 months after delivery in HIV positive and HIV negative women. |
Baseline through 12 months after delivery |
|
Other |
Mother Exploratory outcome 2 - Percentage Serotype specific GBS positive vaginal and/or rectal culture(s) in HIV positive and HIV negative women. |
2. Percentage Serotype specific GBS positive vaginal and/or rectal culture(s) before vaccination, at delivery, and 6 weeks after delivery in HIV positive and HIV negative women. |
Baseline |
|
Other |
Mother Exploratory outcome 2 - Percentage Serotype specific GBS positive vaginal and/or rectal culture(s) in HIV positive and HIV negative women. |
2. Percentage Serotype specific GBS positive vaginal and/or rectal culture(s) at delivery in HIV positive and HIV negative women. |
Delivery |
|
Other |
Mother Exploratory outcome 2 - Percentage Serotype specific GBS positive vaginal and/or rectal culture(s) in HIV positive and HIV negative women. |
2. Percentage Serotype specific GBS positive vaginal and/or rectal culture(s) at 6 weeks after delivery in HIV positive and HIV negative women. |
6 weeks after delivery |
|
Other |
Mother Exploratory outcome 3 - Concentration GBS serotype specific IgG and IgA antibody titres in breast milk following vaccination of women living with HIV and their unexposed counterparts |
3. Concentration GBS serotype specific IgG and IgA antibody titres in breast milk following vaccination of women living with HIV and their unexposed counterparts in colostrum (within 72 hours of delivery) |
within 72 hours after delivery |
|
Other |
Mother Exploratory outcome 3 - Concentration GBS serotype specific IgG and IgA antibody titres in breast milk following vaccination of women living with HIV and their unexposed counterparts |
3. Concentration GBS serotype specific IgG and IgA antibody titres in breast milk following vaccination of women living with HIV and their unexposed counterparts in breast milk at 6 weeks after delivery. |
6 weeks after delivery |
|
Other |
Mother Exploratory outcome 3 - Concentration GBS serotype specific IgG and IgA antibody titres in breast milk following vaccination of women living with HIV and their unexposed counterparts |
3. Concentration GBS serotype specific IgG and IgA antibody titres in breast milk following vaccination of women living with HIV and their unexposed counterparts in breast milk at 18 weeks after delivery. |
18 weeks after delivery |
|
Other |
Infant Exploratory outcome 1 - Concentration IgG antibody titres to vaccines included in the extended programme of vaccination administered to HIV-exposed and unexposed infant participants |
Concentration IgG antibody titres to vaccines included in the extended programme of vaccination administered to HIV-exposed and unexposed infant participants as part of at 18 weeks of age |
18 weeks of age |
|
Other |
Infant Exploratory outcome 1 - Concentration IgG antibody titres to vaccines included in the extended programme of vaccination administered to HIV-exposed and unexposed infant participants |
Concentration IgG antibody titres to vaccines included in the extended programme of vaccination administered to HIV-exposed and unexposed infant participants as part of at 12 months of age. |
12 months of age |
|
Other |
Infant Exploratory outcome 2 - Concentration Serotype specific GBS positive nasal/rectal cultures in infant participants |
2. Concentration Serotype specific GBS positive nasal/rectal cultures at delivery in infant participants. |
Delivery |
|
Other |
Infant Exploratory outcome 2 - Concentration Serotype specific GBS positive nasal/rectal cultures in infant participants |
2. Concentration Serotype specific GBS positive nasal/rectal cultures at 6 weeks after delivery in infant participants. |
6 weeks after delivery |
|
Other |
Infant Exploratory outcome 2 - Concentration Serotype specific GBS positive nasal/rectal cultures in infant participants |
2. Concentration Serotype specific GBS positive nasal/rectal cultures at 18 weeks after delivery in infant participants. |
18 weeks after delivery |
|
Other |
Infant Exploratory outcome 3 - Concentration GBS serotype specific IgG antibody titres measured from dried blood spots in infant participants. |
3. Concentration GBS serotype specific IgG antibody titres measured from dried blood spots in infant participants at birth. |
At birth |
|
Primary |
Primary mother outcome 1 |
1. Percentage Occurrence of solicited local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling). |
7 days following administration of IMP |
|
Primary |
Primary mother outcome 2 |
2. Percentage Occurrence of solicited systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhoea, headache, fatigue/tiredness, muscle pain, and joint pain). |
7 days following administration of IMP |
|
Primary |
Primary mother outcome 3 |
3. Percentage Occurrence of solicited and unsolicited adverse events through 1 month after administration of investigational product. |
Through 1 month following administration of IMP |
|
Primary |
Primary mother outcome 4 |
4. Number Occurrence of SAEs, MAEs, and obstetric complications (peripartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12 month postdelivery study visit) and any unsolicited events leading to study withdrawal. |
Visit 1 through 12 months post-delivery |
|
Primary |
Primary Infant outcome 1 |
1. Number Occurrence of unsolicited adverse events from birth to 6 weeks of age |
Birth to 6 weeks of age |
|
Primary |
Primary Infant outcome 2 |
2. Number Occurrence of SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 12 months of age and any unsolicited events leading to study withdrawal. |
Through 12 months of age |
|
Secondary |
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women |
1. Geometric mean concentration GBS serotype specific IgG antibody titres measured at baseline in HIV positive and HIV negative women. |
Baseline |
|
Secondary |
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women |
1. Geometric mean concentration GBS serotype specific IgG antibody titres measured at 2 weeks after vaccination in HIV positive and HIV negative women. |
2 weeks after vaccination |
|
Secondary |
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women |
1. Geometric mean concentration GBS serotype specific IgG antibody titres measured at 1 month after vaccination in HIV positive and HIV negative women. |
1 month after vaccination |
|
Secondary |
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women |
1. Geometric mean concentration GBS serotype specific IgG antibody titres measured at delivery in HIV positive and HIV negative women. |
Delivery |
|
Secondary |
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women |
1. Geometric mean concentration GBS serotype specific IgG antibody titres measured at 6 weeks after delivery in HIV positive and HIV negative women. |
6 weeks after delivery |
|
Secondary |
Secondary Mother Objective 2 - Geometric mean concentration GBS serotype specific IgG titres in HIV positive and HIV negative women |
2. Geometric mean concentration GBS serotype specific IgG titres measured at baseline in HIV positive and HIV negative women. |
Baseline |
|
Secondary |
Secondary Mother Objective 2 - Geometric mean concentration GBS serotype specific IgG titres in HIV positive and HIV negative wome |
2. Geometric mean concentration GBS serotype specific IgG titres measured at delivery in HIV positive and HIV negative women. |
Delivery |
|
Secondary |
Secondary infant Objective 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants |
1. Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants measured at birth |
Birth |
|
Secondary |
Secondary infant Objective 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants |
1. Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants measured at 18 weeks of life. |
18 weeks |
|
Secondary |
Secondary infant Objective 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants |
1. Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants measured at 12 months of life. |
12 months of life |
|
Secondary |
Secondary infant Objective 2 - Geometric mean concentration GBS serotype specific IgG titres in HIV-exposed and unexposed infant participants |
2. Geometric mean concentration GBS serotype specific IgG titres in HIV-exposed and unexposed infant participants measured at 18 weeks of life. |
18 weeks of life |
|
Secondary |
Secondary infant Objective 3 - Ratio Placental transfer ratio of GBS-specific antibodies in HIV-exposed and unexposed pregnancies. |
3. Ratio Placental transfer ratio of GBS-specific antibodies in HIV-exposed and unexposed pregnancies. |
Delivery |
|