Trial Outcomes & Findings for Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV (NCT NCT04596878)
NCT ID: NCT04596878
Last Updated: 2026-07-14
Results Overview
Incidence of all TEAEs in maternal participants from first vaccination up to 28 days post-delivery.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
From first vaccination (26 to 30 weeks of gestation) up to 28 days post-delivery, up to 24 weeks
Results posted on
2026-07-14
Participant Flow
Participant milestones
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant
|
Placebo Comparator in Pregnant Women Living With HIV
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
20
|
20
|
|
Overall Study
COMPLETED
|
71
|
69
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
1
|
4
|
Reasons for withdrawal
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant
|
Placebo Comparator in Pregnant Women Living With HIV
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Death of a baby
|
1
|
0
|
0
|
1
|
|
Overall Study
Imprisonment
|
1
|
0
|
0
|
0
|
|
Overall Study
Unable to come for follow-ups due to relocation or new job
|
2
|
2
|
0
|
0
|
Baseline Characteristics
Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV
Baseline characteristics by cohort
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=80 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=80 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
80 Participants
n=9 Participants
|
80 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
20 Participants
n=265 Participants
|
200 Participants
n=568 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Age, Continuous
|
31.4 years
STANDARD_DEVIATION 4.8 • n=9 Participants
|
26.4 years
STANDARD_DEVIATION 5.4 • n=27 Participants
|
31.0 years
STANDARD_DEVIATION 5.5 • n=267 Participants
|
26.3 years
STANDARD_DEVIATION 5.3 • n=265 Participants
|
28.9 years
STANDARD_DEVIATION 5.7 • n=568 Participants
|
|
Sex: Female, Male
Female
|
80 Participants
n=9 Participants
|
80 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
20 Participants
n=265 Participants
|
200 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=9 Participants
|
80 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
20 Participants
n=265 Participants
|
199 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
80 Participants
n=9 Participants
|
78 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
20 Participants
n=265 Participants
|
198 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Region of Enrollment
South Africa
|
59 participants
n=9 Participants
|
60 participants
n=27 Participants
|
16 participants
n=267 Participants
|
15 participants
n=265 Participants
|
150 participants
n=568 Participants
|
|
Region of Enrollment
Uganda
|
21 participants
n=9 Participants
|
20 participants
n=27 Participants
|
4 participants
n=267 Participants
|
5 participants
n=265 Participants
|
50 participants
n=568 Participants
|
PRIMARY outcome
Timeframe: From first vaccination (26 to 30 weeks of gestation) up to 28 days post-delivery, up to 24 weeksPopulation: Safety Analysis Set (SAF)
Incidence of all TEAEs in maternal participants from first vaccination up to 28 days post-delivery.
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=80 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=80 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (TEAEs) in Maternal Participants
|
229 Adverse Events
|
223 Adverse Events
|
55 Adverse Events
|
48 Adverse Events
|
PRIMARY outcome
Timeframe: From birth to first visit after birth (28±4 days post-delivery)Population: Baby Safety Analysis Set (BSA)
Incidence of AEs in Newborn babies From birth to first visit after birth (visit 6).
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=78 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=79 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Incidence of Adverse Events (AEs) in Newborn Babies
|
273 Adverse Events
|
191 Adverse Events
|
68 Adverse Events
|
54 Adverse Events
|
PRIMARY outcome
Timeframe: For 7 days after each study vaccine dose (first vaccine administered at baseline, second vaccine administered 28 days post baseline)Population: SAF
Number of maternal participants with solicited local AEs within 7 Days after each study vaccine dose, defined as: injection site redness, bruising, swelling, itching, pain and tenderness. Injection-site redness was graded based on measurements in centimeter (cm) as grade 0 (no visible redness), grade 1 (mild; 0-2 cm), grade 2 (moderate; 2.1-5 cm) or grade 3 (severe; \> 5 cm). Swelling was graded as grade 0 (no swelling detected), grade 1 (palpable "firmness" only), grade 2 (0-4 cm) or grade 3 (\> 4 cm). Pain at the injection site was rated on a visual analogue scale of 0 to 10, where 0 is no pain and 10 is extreme pain/worst possible pain. Bruising, itching and tenderness were categorised as either yes (present) or no (absent).
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=80 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=80 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Bruising - No
|
77 participants
|
76 participants
|
20 participants
|
19 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Bruising - Yes
|
3 participants
|
4 participants
|
0 participants
|
1 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Itching - No
|
74 participants
|
71 participants
|
20 participants
|
17 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Itching - Yes
|
6 participants
|
9 participants
|
0 participants
|
3 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Redness - 1
|
12 participants
|
17 participants
|
2 participants
|
3 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Redness - 2
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Redness - 3
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Swelling - 2
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Swelling - 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Tenderness - Yes
|
73 participants
|
71 participants
|
19 participants
|
18 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Pain - 1
|
15 participants
|
22 participants
|
0 participants
|
3 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Pain - 2
|
11 participants
|
15 participants
|
2 participants
|
2 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Pain - 3
|
6 participants
|
6 participants
|
1 participants
|
2 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Pain - 4
|
4 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Pain - 5
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Pain - 7
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Pain - 10
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Bruising - Yes
|
6 participants
|
6 participants
|
0 participants
|
2 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Itching - Yes
|
11 participants
|
12 participants
|
0 participants
|
2 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Redness - 1
|
6 participants
|
13 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Redness - 2
|
6 participants
|
5 participants
|
0 participants
|
1 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Redness - 3
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Swelling - 0
|
59 participants
|
52 participants
|
17 participants
|
15 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Swelling - 1
|
17 participants
|
23 participants
|
1 participants
|
4 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Swelling - 2
|
2 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Swelling - 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Tenderness - No
|
3 participants
|
4 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Tenderness - Yes
|
75 participants
|
73 participants
|
18 participants
|
20 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Pain - 0
|
35 participants
|
29 participants
|
14 participants
|
16 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Pain - 1
|
16 participants
|
17 participants
|
2 participants
|
1 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Pain - 2
|
13 participants
|
12 participants
|
1 participants
|
1 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Pain - 3
|
7 participants
|
11 participants
|
0 participants
|
1 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Pain - 4
|
3 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Pain - 5
|
2 participants
|
4 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Pain - 6
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Pain - 7
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Pain - 8
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Pain - 9
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Pain - 10
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Redness - 0
|
67 participants
|
61 participants
|
18 participants
|
16 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Swelling - 0
|
62 participants
|
56 participants
|
18 participants
|
13 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Swelling - 1
|
17 participants
|
22 participants
|
2 participants
|
5 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Tenderness - No
|
7 participants
|
9 participants
|
1 participants
|
2 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Pain - 0
|
38 participants
|
32 participants
|
16 participants
|
11 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Pain - 6
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Pain - 8
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 1 : Pain - 9
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Bruising - No
|
72 participants
|
71 participants
|
18 participants
|
18 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Itching - No
|
67 participants
|
65 participants
|
18 participants
|
19 participants
|
|
Number of Maternal Participants With Solicited Local AEs Within 7 Days After Each Study Vaccine Dose
Post-Dose 2 : Redness - 0
|
65 participants
|
59 participants
|
18 participants
|
19 participants
|
PRIMARY outcome
Timeframe: For 7 days after each study vaccine dose (first vaccine administered at baseline, second vaccine administered 28 days post baseline)Population: SAF
Number of maternal participants with solicited systemic AEs within 7 days after each study vaccine dose, defined as: headache, sore throat, "flu-like" symptoms, muscle aches, fever in the 72 hours post dose.
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=80 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=80 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Headache - Moderate
|
8 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Headache - Severe
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Sore throat - Mild
|
8 Participants
|
15 Participants
|
2 Participants
|
3 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Headache - Mild
|
17 Participants
|
21 Participants
|
3 Participants
|
7 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Sore throat - Moderate
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Sore throat - Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Flu-like symptoms - Mild
|
14 Participants
|
17 Participants
|
3 Participants
|
7 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Flu-like symptoms - Moderate
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Flu-like symptoms - Severe
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Muscle aches - Mild
|
19 Participants
|
16 Participants
|
4 Participants
|
6 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Muscle aches - Moderate
|
7 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Muscle aches - Severe
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 1 : Fever ≥ 37.9°C
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Headache - Mild
|
14 Participants
|
17 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Headache - Moderate
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Headache - Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Sore throat - Mild
|
5 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Sore throat - Moderate
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Sore throat - Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Flu-like symptoms - Mild
|
13 Participants
|
9 Participants
|
1 Participants
|
3 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Flu-like symptoms - Moderate
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Flu-like symptoms - Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Muscle aches - Mild
|
12 Participants
|
16 Participants
|
3 Participants
|
2 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Muscle aches - Moderate
|
6 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Muscle aches - Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Maternal Participants With Solicited Systemic AEs Within 7 Days After Each Study Vaccine Dose
Post-dose 2 : Fever ≥ 37.9°C
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At birthPopulation: Baby Safety Analysis Set
Gestational age of newborn baby
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=78 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=77 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Gestational Age of Newborn Baby
|
39.0 Weeks
Standard Deviation 2.0
|
39.1 Weeks
Standard Deviation 2.1
|
37.9 Weeks
Standard Deviation 3.7
|
39.0 Weeks
Standard Deviation 2.0
|
PRIMARY outcome
Timeframe: At birthPopulation: Baby Safety Analysis Set
Weight of newborn baby
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=78 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=79 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=19 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Weight of Newborn Baby
|
3.0 Kg
Standard Deviation 0.6
|
3.0 Kg
Standard Deviation 0.5
|
2.7 Kg
Standard Deviation 0.6
|
3.2 Kg
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: At birthPopulation: Baby Safety Analysis Set
Length of newborn baby
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=78 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=79 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Length of Newborn Baby
|
49.6 cm
Standard Deviation 3.4
|
49.0 cm
Standard Deviation 2.3
|
47.8 cm
Standard Deviation 4.9
|
50.8 cm
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: At birthPopulation: Baby Safety Analysis Set
Head circumference of newborn baby
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=78 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=79 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Head Circumference of Newborn Baby
|
34.2 cm
Standard Deviation 1.6
|
34.2 cm
Standard Deviation 1.4
|
32.6 cm
Standard Deviation 3.9
|
34.9 cm
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: At birthPopulation: Baby Safety Analysis Set; APGAR score at 10 minutes were evaluated in babies with APGAR score \< 10 at 1 and 5 minutes.
APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score of newborn baby were measured at 1, 5 and 10 minutes. The APGAR score is a rapid clinical assessment tool used immediately after birth to evaluate a newborn's physical condition. It evaluates five criteria : Appearance (skin color), Pulse (heart rate), Grimace (Reflex irritability), Activity (muscle tone), Respiration (breathing effort), each category is scored 0, 1, or 2, where 2 indicates optimal function. Total score ranges from 0 to 10: 7-10: Normal / Reassuring - baby adapting well 4-6: Moderately abnormal - may need assisted breathing or additional monitoring 0-3: Low - requires immediate resuscitation and urgent intervention
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=74 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=78 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=19 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Apgar Score for Newborn Baby
1 minute
|
8.6 score on a scale
Standard Deviation 1.1
|
8.6 score on a scale
Standard Deviation 1.0
|
8.0 score on a scale
Standard Deviation 2.1
|
8.8 score on a scale
Standard Deviation 0.6
|
|
Apgar Score for Newborn Baby
5 minutes
|
9.8 score on a scale
Standard Deviation 0.4
|
9.7 score on a scale
Standard Deviation 0.8
|
9.6 score on a scale
Standard Deviation 0.8
|
9.8 score on a scale
Standard Deviation 0.5
|
|
Apgar Score for Newborn Baby
10 minutes
|
9.9 score on a scale
Standard Deviation 0.3
|
9.5 score on a scale
Standard Deviation 1.0
|
9.0 score on a scale
Standard Deviation 1.0
|
10.0 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At deliveryPopulation: Baby Immunogenicity Set
For each of the specific IgG antibody concentrations, the transfer rate is defined as concentration in baby at birth/concentration in mother at delivery, expressed as a percentage.
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=26 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=34 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=7 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=11 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Transfer Rate (Baby/Mother) of IgG Antibody Concentrations
Alp1N
|
80.5 percentage
Interval 56.2 to 94.7
|
114.4 percentage
Interval 55.5 to 149.4
|
34.1 percentage
Interval 27.5 to 47.3
|
36.1 percentage
Interval 3.6 to 73.2
|
|
Transfer Rate (Baby/Mother) of IgG Antibody Concentrations
Alp2N
|
56.4 percentage
Interval 30.2 to 89.7
|
110.5 percentage
Interval 65.7 to 138.8
|
34.7 percentage
Interval 19.8 to 54.2
|
50.3 percentage
Interval 6.7 to 100.0
|
|
Transfer Rate (Baby/Mother) of IgG Antibody Concentrations
RibN
|
87.5 percentage
Interval 56.1 to 110.6
|
122.1 percentage
Interval 56.7 to 156.0
|
37.2 percentage
Interval 33.0 to 57.6
|
14.5 percentage
Interval 5.1 to 89.1
|
|
Transfer Rate (Baby/Mother) of IgG Antibody Concentrations
AlpCN
|
69.8 percentage
Interval 37.7 to 100.8
|
119.0 percentage
Interval 4.9 to 155.5
|
49.9 percentage
Interval 30.0 to 58.1
|
10.6 percentage
Interval 5.6 to 54.9
|
SECONDARY outcome
Timeframe: From delivery to 6 months post-deliveryPopulation: Safety Analysis Set (SAF)
Incidence of significant adverse reactions in maternal participants
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=80 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=80 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=20 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Incidence of Significant Adverse Reactions in Mothers
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
0 Adverse Events
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Baby Safety Analysis Set
Developmental milestones at 6 months were assessed using the Ages and Stages Questionnaire, Third Edition (ASQ-3), a validated developmental screening tool designed to evaluate early childhood development across 5 key domains: communication, gross motor, fine motor, problem solving, and personal-social. Each domain includes 6 items scored as Yes (10), Sometimes (5), or Not yet (0). Domain scores are calculated by summing item scores (range: 0-60 per domain); higher scores indicate better development. A total score (sum of all domains) may be calculated (range: 0-300), though interpretation relies primarily on domain scores. For each domain, the cut-offs are 29.65 for Communication, 22.25 for Gross Motor, 25.14 for Fine Motor, 27.72 for Problem Solving, and 25.34 for Personal-Social. Scores above these thresholds generally indicate development on schedule, while scores near the cutoff suggest monitoring, and scores below warrant additional assessment or referral.
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=72 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=68 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=18 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=16 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Developmental Milestones of Babies
Communication Score
|
53.5 score on a scale
Standard Deviation 6.2
|
51.9 score on a scale
Standard Deviation 8.9
|
52.8 score on a scale
Standard Deviation 7.3
|
54.7 score on a scale
Standard Deviation 6.9
|
|
Developmental Milestones of Babies
Fine Motor Score
|
55.6 score on a scale
Standard Deviation 7.0
|
51.7 score on a scale
Standard Deviation 10.4
|
56.7 score on a scale
Standard Deviation 5.7
|
54.1 score on a scale
Standard Deviation 7.4
|
|
Developmental Milestones of Babies
Gross Motor Score
|
49.9 score on a scale
Standard Deviation 7.9
|
46.8 score on a scale
Standard Deviation 11.3
|
50.0 score on a scale
Standard Deviation 7.5
|
50.0 score on a scale
Standard Deviation 8.0
|
|
Developmental Milestones of Babies
Problem Solving Score
|
56.7 score on a scale
Standard Deviation 5.6
|
53.5 score on a scale
Standard Deviation 7.6
|
54.4 score on a scale
Standard Deviation 5.9
|
55.3 score on a scale
Standard Deviation 6.9
|
|
Developmental Milestones of Babies
Personal Social Score
|
52.4 score on a scale
Standard Deviation 9.1
|
48.7 score on a scale
Standard Deviation 11.6
|
52.6 score on a scale
Standard Deviation 6.7
|
52.8 score on a scale
Standard Deviation 11.8
|
|
Developmental Milestones of Babies
Total Domain Score
|
268.1 score on a scale
Standard Deviation 22.9
|
252.5 score on a scale
Standard Deviation 36.9
|
266.5 score on a scale
Standard Deviation 19.5
|
266.9 score on a scale
Standard Deviation 25.6
|
SECONDARY outcome
Timeframe: At 4 weeks post first injection and at 4 weeks post second injectionPopulation: Maternal Immunogenicity Set
Geometric mean IgG antibody concentration in the maternal participants specific to Alpha Like Protein 1 (Alp1), Alpha Like Protein 2 (Alp2), Alpha Like Protein C (AlpC) and Rib protein (Rib).
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=58 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=60 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=16 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=15 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
Rib - Baseline
|
0.2 µg/mL
Geometric Coefficient of Variation 150.4
|
0.1 µg/mL
Geometric Coefficient of Variation 104.9
|
0.1 µg/mL
Geometric Coefficient of Variation 86.0
|
0.1 µg/mL
Geometric Coefficient of Variation 114.9
|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
Alp2 - Baseline
|
0.1 µg/mL
Geometric Coefficient of Variation 166.9
|
0.1 µg/mL
Geometric Coefficient of Variation 130.3
|
0.1 µg/mL
Geometric Coefficient of Variation 234.8
|
0.1 µg/mL
Geometric Coefficient of Variation 207.9
|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
Alp2 - 4 weeks post 1st injection
|
4.4 µg/mL
Geometric Coefficient of Variation 212.0
|
4.8 µg/mL
Geometric Coefficient of Variation 452.7
|
0.1 µg/mL
Geometric Coefficient of Variation 288.9
|
0.1 µg/mL
Geometric Coefficient of Variation 155.9
|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
Alp1 - Baseline
|
0.2 µg/mL
Geometric Coefficient of Variation 147.8
|
0.2 µg/mL
Geometric Coefficient of Variation 106.0
|
0.2 µg/mL
Geometric Coefficient of Variation 196.1
|
0.2 µg/mL
Geometric Coefficient of Variation 133.9
|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
Alp1 - 4 weeks post 1st injection
|
6.2 µg/mL
Geometric Coefficient of Variation 229.4
|
5.9 µg/mL
Geometric Coefficient of Variation 375.0
|
0.2 µg/mL
Geometric Coefficient of Variation 200.2
|
0.2 µg/mL
Geometric Coefficient of Variation 125.7
|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
Alp1 - 4 weeks post 2nd injection
|
9.2 µg/mL
Geometric Coefficient of Variation 138.4
|
9.8 µg/mL
Geometric Coefficient of Variation 178.9
|
0.2 µg/mL
Geometric Coefficient of Variation 173.4
|
0.3 µg/mL
Geometric Coefficient of Variation 384.4
|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
Alp2 - 4 weeks post 2nd injection
|
7.1 µg/mL
Geometric Coefficient of Variation 137.4
|
7.0 µg/mL
Geometric Coefficient of Variation 177.2
|
0.1 µg/mL
Geometric Coefficient of Variation 239.9
|
0.1 µg/mL
Geometric Coefficient of Variation 829.1
|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
AlpC - Baseline
|
0.2 µg/mL
Geometric Coefficient of Variation 114.7
|
0.2 µg/mL
Geometric Coefficient of Variation 101.1
|
0.2 µg/mL
Geometric Coefficient of Variation 170.9
|
0.2 µg/mL
Geometric Coefficient of Variation 115.8
|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
AlpC - 4 weeks post 1st injection
|
10.5 µg/mL
Geometric Coefficient of Variation 243.8
|
7.6 µg/mL
Geometric Coefficient of Variation 411.2
|
0.2 µg/mL
Geometric Coefficient of Variation 161.1
|
0.2 µg/mL
Geometric Coefficient of Variation 141.0
|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
AlpC - 4 weeks post 2nd injection
|
12.2 µg/mL
Geometric Coefficient of Variation 210.3
|
10.0 µg/mL
Geometric Coefficient of Variation 204.4
|
0.2 µg/mL
Geometric Coefficient of Variation 151.8
|
0.2 µg/mL
Geometric Coefficient of Variation 298.3
|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
Rib - 4 weeks post 1st injection
|
4.2 µg/mL
Geometric Coefficient of Variation 284.8
|
3.3 µg/mL
Geometric Coefficient of Variation 477.0
|
0.1 µg/mL
Geometric Coefficient of Variation 101.5
|
0.1 µg/mL
Geometric Coefficient of Variation 115.0
|
|
Geometric Mean Antibody Concentration in Maternal Participants (4 Weeks)
Rib - 4 weeks post 2nd injection
|
4.5 µg/mL
Geometric Coefficient of Variation 251.3
|
4.6 µg/mL
Geometric Coefficient of Variation 263.2
|
0.1 µg/mL
Geometric Coefficient of Variation 112.3
|
0.1 µg/mL
Geometric Coefficient of Variation 255.1
|
SECONDARY outcome
Timeframe: 6 months post-deliveryPopulation: MIG
Geometric mean antibody concentration specific to Alp1, Alp2, AlpC and Rib in maternal blood at 6 months post-delivery
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=58 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=60 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=16 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=15 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Geometric Mean Antibody Concentration in Maternal Blood at 6 Months Post-delivery
Rib
|
1.6 ug/mL
Geometric Coefficient of Variation 255.3
|
1.8 ug/mL
Geometric Coefficient of Variation 223.3
|
0.2 ug/mL
Geometric Coefficient of Variation 72.5
|
0.1 ug/mL
Geometric Coefficient of Variation 78.4
|
|
Geometric Mean Antibody Concentration in Maternal Blood at 6 Months Post-delivery
AlpC
|
3.8 ug/mL
Geometric Coefficient of Variation 240.3
|
4.1 ug/mL
Geometric Coefficient of Variation 222.2
|
0.2 ug/mL
Geometric Coefficient of Variation 138.2
|
0.2 ug/mL
Geometric Coefficient of Variation 99.2
|
|
Geometric Mean Antibody Concentration in Maternal Blood at 6 Months Post-delivery
Alp1
|
2.5 ug/mL
Geometric Coefficient of Variation 199.1
|
4.1 ug/mL
Geometric Coefficient of Variation 187.9
|
0.3 ug/mL
Geometric Coefficient of Variation 173.0
|
0.2 ug/mL
Geometric Coefficient of Variation 149.3
|
|
Geometric Mean Antibody Concentration in Maternal Blood at 6 Months Post-delivery
Alp2
|
2.0 ug/mL
Geometric Coefficient of Variation 201.3
|
3.2 ug/mL
Geometric Coefficient of Variation 230.9
|
0.1 ug/mL
Geometric Coefficient of Variation 217.8
|
0.1 ug/mL
Geometric Coefficient of Variation 146.6
|
SECONDARY outcome
Timeframe: At 1, 2, and 3 months post-deliveryPopulation: BIG population
Geometric mean antibody concentration specific to Alp1, Alp2, AlpC and Rib in infant blood at 1, 2, and 3 months post-delivery
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=26 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=34 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=7 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=11 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
Alp2 - 3 months
|
0.7 ug/mL
Geometric Coefficient of Variation 111.7
|
1.1 ug/mL
Geometric Coefficient of Variation 983.2
|
0.1 ug/mL
Geometric Coefficient of Variation 58.3
|
0.0 ug/mL
Geometric Coefficient of Variation 115.9
|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
AlpC - 1 month
|
2.5 ug/mL
Geometric Coefficient of Variation 311.1
|
1.7 ug/mL
Geometric Coefficient of Variation 1398.8
|
0.0 ug/mL
Geometric Coefficient of Variation 59.5
|
0.0 ug/mL
Geometric Coefficient of Variation 204.9
|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
AlpC - 2 months
|
1.2 ug/mL
Geometric Coefficient of Variation 289.3
|
0.6 ug/mL
Geometric Coefficient of Variation 2852.9
|
0.0 ug/mL
Geometric Coefficient of Variation 66.0
|
0.1 ug/mL
Geometric Coefficient of Variation 295.2
|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
Alp1 - 1 month
|
2.5 ug/mL
Geometric Coefficient of Variation 193.7
|
1.8 ug/mL
Geometric Coefficient of Variation 1226.2
|
0.1 ug/mL
Geometric Coefficient of Variation 909.5
|
0.0 ug/mL
Geometric Coefficient of Variation 379.3
|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
Alp1 - 2 months
|
1.2 ug/mL
Geometric Coefficient of Variation 236.0
|
0.5 ug/mL
Geometric Coefficient of Variation 2880.4
|
0.0 ug/mL
Geometric Coefficient of Variation 154.8
|
0.1 ug/mL
Geometric Coefficient of Variation 329.9
|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
Alp1 - 3 months
|
1.5 ug/mL
Geometric Coefficient of Variation 122.3
|
0.8 ug/mL
Geometric Coefficient of Variation 3108.7
|
0.2 ug/mL
Geometric Coefficient of Variation 27.2
|
0.1 ug/mL
Geometric Coefficient of Variation 89.1
|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
Alp2 - 1 month
|
1.4 ug/mL
Geometric Coefficient of Variation 285.8
|
1.4 ug/mL
Geometric Coefficient of Variation 1085.8
|
0.0 ug/mL
Geometric Coefficient of Variation 1175.7
|
0.0 ug/mL
Geometric Coefficient of Variation 163.2
|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
Alp2 - 2 months
|
0.8 ug/mL
Geometric Coefficient of Variation 323.5
|
0.5 ug/mL
Geometric Coefficient of Variation 2171.6
|
0.0 ug/mL
Geometric Coefficient of Variation 178.3
|
0.1 ug/mL
Geometric Coefficient of Variation 199.9
|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
AlpC - 3 months
|
1.6 ug/mL
Geometric Coefficient of Variation 455.9
|
1.0 ug/mL
Geometric Coefficient of Variation 4809.1
|
0.1 ug/mL
Geometric Coefficient of Variation 6.9
|
0.1 ug/mL
Geometric Coefficient of Variation 85.9
|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
Rib - 1 month
|
1.3 ug/mL
Geometric Coefficient of Variation 280.6
|
1.4 ug/mL
Geometric Coefficient of Variation 397.6
|
0.1 ug/mL
Geometric Coefficient of Variation 3373.8
|
0.0 ug/mL
Geometric Coefficient of Variation 254.0
|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
Rib - 2 months
|
0.8 ug/mL
Geometric Coefficient of Variation 205.5
|
1.1 ug/mL
Geometric Coefficient of Variation 640.2
|
0.1 ug/mL
Geometric Coefficient of Variation 165.5
|
0.0 ug/mL
Geometric Coefficient of Variation 238.9
|
|
Geometric Mean Antibody Concentration in Infant Blood at 1, 2, and 3 Months Post-delivery
Rib - 3 months
|
0.8 ug/mL
Geometric Coefficient of Variation 340.3
|
0.6 ug/mL
Geometric Coefficient of Variation 859.4
|
0.1 ug/mL
Geometric Coefficient of Variation 42.8
|
0.1 ug/mL
Geometric Coefficient of Variation 108.3
|
SECONDARY outcome
Timeframe: Within 48 hours of birth.Population: Baby Immunogenicity Set
Geometric mean antibody concentration specific to Alp1, Alp2, AlpC and Rib in newborn blood within 48 hours of birth.
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=26 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=34 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=7 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=11 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Geometric Mean Antibody Concentration in Newborns
Alp1
|
3.6 µg/ml
Geometric Coefficient of Variation 221.9
|
2.1 µg/ml
Geometric Coefficient of Variation 3054.4
|
0.0 µg/ml
Geometric Coefficient of Variation 107.4
|
0.0 µg/ml
Geometric Coefficient of Variation 596.2
|
|
Geometric Mean Antibody Concentration in Newborns
Alp2
|
2.0 µg/ml
Geometric Coefficient of Variation 325.3
|
1.7 µg/ml
Geometric Coefficient of Variation 1893.1
|
0.0 µg/ml
Geometric Coefficient of Variation 81.5
|
0.0 µg/ml
Geometric Coefficient of Variation 184.5
|
|
Geometric Mean Antibody Concentration in Newborns
AlpC
|
2.2 µg/ml
Geometric Coefficient of Variation 443.9
|
1.9 µg/ml
Geometric Coefficient of Variation 3975.3
|
0.1 µg/ml
Geometric Coefficient of Variation 96.6
|
0.0 µg/ml
Geometric Coefficient of Variation 518.7
|
|
Geometric Mean Antibody Concentration in Newborns
Rib
|
1.7 µg/ml
Geometric Coefficient of Variation 419.1
|
1.4 µg/ml
Geometric Coefficient of Variation 1272.7
|
0.1 µg/ml
Geometric Coefficient of Variation 227.1
|
0.0 µg/ml
Geometric Coefficient of Variation 525.0
|
SECONDARY outcome
Timeframe: At deliveryPopulation: Maternal Immunogenicity Set
Geometric mean antibody concentration specific to Alp1, Alp2, AlpC and Rib from maternal blood at delivery
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=58 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=60 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=16 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=15 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Geometric Mean Antibody Concentration From Maternal Blood at Delivery
Alp1
|
6.8 µg/mL
Geometric Coefficient of Variation 194.4
|
7.3 µg/mL
Geometric Coefficient of Variation 138.3
|
0.2 µg/mL
Geometric Coefficient of Variation 167.9
|
0.2 µg/mL
Geometric Coefficient of Variation 123.5
|
|
Geometric Mean Antibody Concentration From Maternal Blood at Delivery
Alp2
|
5.4 µg/mL
Geometric Coefficient of Variation 168.9
|
5.5 µg/mL
Geometric Coefficient of Variation 187.9
|
0.1 µg/mL
Geometric Coefficient of Variation 199.3
|
0.1 µg/mL
Geometric Coefficient of Variation 146.3
|
|
Geometric Mean Antibody Concentration From Maternal Blood at Delivery
AlpC
|
8.8 µg/mL
Geometric Coefficient of Variation 207.7
|
8.6 µg/mL
Geometric Coefficient of Variation 183.8
|
0.2 µg/mL
Geometric Coefficient of Variation 134.2
|
0.2 µg/mL
Geometric Coefficient of Variation 146.8
|
|
Geometric Mean Antibody Concentration From Maternal Blood at Delivery
Rib
|
3.4 µg/mL
Geometric Coefficient of Variation 343.9
|
3.2 µg/mL
Geometric Coefficient of Variation 285.9
|
0.1 µg/mL
Geometric Coefficient of Variation 80.3
|
0.1 µg/mL
Geometric Coefficient of Variation 112.4
|
SECONDARY outcome
Timeframe: At 4 weeks post first injection and at 4 weeks post second injectionPopulation: Maternal Immunogenicity Set
Geometric mean fold increase in IgG specific antibody concentration (Alp1, Alp2, AlpC and Rib) in maternal blood from baseline to 4 weeks after vaccination with the first and second dose.
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=58 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=60 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=16 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=15 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
Alp2N - 4 weeks post-Dose 2
|
64.0 Geometric mean fold increase
Interval 41.5 to 98.8
|
73.8 Geometric mean fold increase
Interval 54.4 to 100.2
|
0.9 Geometric mean fold increase
Interval 0.7 to 1.2
|
1.6 Geometric mean fold increase
Interval 0.4 to 5.6
|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
AlpCN - 4 weeks post-Dose 1
|
49.5 Geometric mean fold increase
Interval 34.2 to 71.7
|
39.1 Geometric mean fold increase
Interval 26.4 to 57.8
|
1.0 Geometric mean fold increase
Interval 0.8 to 1.2
|
1.0 Geometric mean fold increase
Interval 0.8 to 1.2
|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
AlpCN - 4 weeks post-Dose 2
|
65.1 Geometric mean fold increase
Interval 47.9 to 88.4
|
55.9 Geometric mean fold increase
Interval 41.5 to 75.2
|
1.0 Geometric mean fold increase
Interval 0.8 to 1.3
|
1.1 Geometric mean fold increase
Interval 0.6 to 1.9
|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
RibN - 4 weeks post-Dose 1
|
28.5 Geometric mean fold increase
Interval 19.6 to 41.3
|
31.2 Geometric mean fold increase
Interval 20.7 to 47.1
|
1.0 Geometric mean fold increase
Interval 0.8 to 1.3
|
1.0 Geometric mean fold increase
Interval 0.9 to 1.1
|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
RibN - 4 weeks post-Dose 2
|
27.7 Geometric mean fold increase
Interval 17.3 to 44.4
|
41.4 Geometric mean fold increase
Interval 29.3 to 58.5
|
1.0 Geometric mean fold increase
Interval 0.7 to 1.3
|
1.1 Geometric mean fold increase
Interval 0.6 to 1.9
|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
Alp1N - 4 weeks post-Dose 1
|
35.6 Geometric mean fold increase
Interval 24.9 to 50.9
|
32.9 Geometric mean fold increase
Interval 22.5 to 48.0
|
1.0 Geometric mean fold increase
Interval 0.8 to 1.3
|
1.0 Geometric mean fold increase
Interval 0.9 to 1.1
|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
Alp1N - 4 weeks post-Dose 2
|
47.6 Geometric mean fold increase
Interval 34.9 to 65.0
|
59.1 Geometric mean fold increase
Interval 42.9 to 81.5
|
0.9 Geometric mean fold increase
Interval 0.7 to 1.2
|
1.3 Geometric mean fold increase
Interval 0.5 to 3.4
|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
Alp2N - 4 weeks post-Dose 1
|
41.0 Geometric mean fold increase
Interval 27.4 to 61.4
|
43.9 Geometric mean fold increase
Interval 30.5 to 63.2
|
0.8 Geometric mean fold increase
Interval 0.6 to 1.0
|
1.1 Geometric mean fold increase
Interval 0.9 to 1.3
|
SECONDARY outcome
Timeframe: Baseline (Gestational Age 26 to 30 weeks) pre-vaccination to delivery, up to 24 weeksPopulation: Maternal Immunogenicity Set
Geometric mean fold increase in IgG specific antibody concentration (Alp1, Alp2, AlpC and Rib) in maternal blood from baseline to delivery.
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=58 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=60 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=16 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=15 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
AlpCN
|
45.5 Geometric mean fold increase
Interval 32.0 to 64.7
|
43.4 Geometric mean fold increase
Interval 33.2 to 56.7
|
0.8 Geometric mean fold increase
Interval 0.7 to 1.0
|
0.9 Geometric mean fold increase
Interval 0.7 to 1.1
|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
RibN
|
23.1 Geometric mean fold increase
Interval 15.1 to 35.2
|
30.3 Geometric mean fold increase
Interval 20.7 to 44.3
|
0.8 Geometric mean fold increase
Interval 0.6 to 1.1
|
0.9 Geometric mean fold increase
Interval 0.7 to 1.1
|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
Alp1N
|
37.3 Geometric mean fold increase
Interval 27.7 to 50.0
|
42.3 Geometric mean fold increase
Interval 31.9 to 56.0
|
0.8 Geometric mean fold increase
Interval 0.7 to 1.0
|
0.9 Geometric mean fold increase
Interval 0.7 to 1.0
|
|
Geometric Mean Fold Increase in Antibody Concentration in Maternal Blood
Alp2N
|
49.2 Geometric mean fold increase
Interval 32.4 to 74.7
|
51.2 Geometric mean fold increase
Interval 37.9 to 69.2
|
0.8 Geometric mean fold increase
Interval 0.7 to 1.0
|
1.0 Geometric mean fold increase
Interval 0.7 to 1.3
|
SECONDARY outcome
Timeframe: At deliveryPopulation: Maternal immunogenicity analysis set
Proportion of mothers achieving vaccine specific IgG antibody concentrations in maternal samples respectively, above pre-defined arbitrary thresholds (0.5, 1, 2 μg/mL).
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=58 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=60 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=16 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=15 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
Alp1N >0.5
|
98.0 percentage of mothers
Interval 89.5 to 99.7
|
100 percentage of mothers
Interval 93.5 to 100.0
|
14.3 percentage of mothers
Interval 4.0 to 39.9
|
13.3 percentage of mothers
Interval 3.7 to 37.9
|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
Alp1N >1
|
96.0 percentage of mothers
Interval 86.5 to 98.9
|
98.2 percentage of mothers
Interval 90.4 to 99.7
|
7.1 percentage of mothers
Interval 1.3 to 31.5
|
0 percentage of mothers
Interval 0.0 to 0.0
|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
Alp1N >2
|
82.0 percentage of mothers
Interval 69.2 to 90.2
|
92.7 percentage of mothers
Interval 82.7 to 97.1
|
7.1 percentage of mothers
Interval 1.3 to 31.5
|
0 percentage of mothers
Interval 0.0 to 0.0
|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
Alp2N >0.5
|
98.0 percentage of mothers
Interval 89.3 to 99.6
|
100 percentage of mothers
Interval 93.1 to 100.0
|
7.7 percentage of mothers
Interval 1.4 to 33.3
|
7.1 percentage of mothers
Interval 1.3 to 31.5
|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
Alp2N >1
|
91.8 percentage of mothers
Interval 80.8 to 96.8
|
90.4 percentage of mothers
Interval 79.4 to 95.8
|
0 percentage of mothers
Interval 0.0 to 0.0
|
0 percentage of mothers
Interval 0.0 to 0.0
|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
Alp2N >2
|
83.7 percentage of mothers
Interval 71.0 to 91.5
|
75.0 percentage of mothers
Interval 61.8 to 84.8
|
0 percentage of mothers
Interval 0.0 to 0.0
|
0 percentage of mothers
Interval 0.0 to 0.0
|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
AlpCN >0.5
|
100 percentage of mothers
Interval 92.9 to 100.0
|
98.2 percentage of mothers
Interval 90.4 to 99.7
|
7.1 percentage of mothers
Interval 1.3 to 31.5
|
21.4 percentage of mothers
Interval 7.6 to 47.6
|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
AlpCN >1
|
92.0 percentage of mothers
Interval 81.2 to 96.9
|
94.6 percentage of mothers
Interval 85.2 to 98.1
|
7.1 percentage of mothers
Interval 1.3 to 31.5
|
0 percentage of mothers
Interval 0.0 to 0.0
|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
AlpCN >2
|
84.0 percentage of mothers
Interval 71.5 to 91.7
|
89.1 percentage of mothers
Interval 78.2 to 94.9
|
0 percentage of mothers
Interval 0.0 to 0.0
|
0 percentage of mothers
Interval 0.0 to 0.0
|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
RibN >0.5
|
87.2 percentage of mothers
Interval 74.8 to 94.0
|
88.5 percentage of mothers
Interval 77.0 to 94.6
|
7.1 percentage of mothers
Interval 1.3 to 31.5
|
0 percentage of mothers
Interval 0.0 to 0.0
|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
RibN >1
|
76.6 percentage of mothers
Interval 62.8 to 86.4
|
76.9 percentage of mothers
Interval 63.9 to 86.3
|
0 percentage of mothers
Interval 0.0 to 0.0
|
0 percentage of mothers
Interval 0.0 to 0.0
|
|
Proportion of Mothers Achieving Vaccine Specific IgG Antibody Concentrations
RibN >2
|
63.8 percentage of mothers
Interval 49.5 to 76.0
|
63.5 percentage of mothers
Interval 49.9 to 75.2
|
0 percentage of mothers
Interval 0.0 to 0.0
|
0 percentage of mothers
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: At birthPopulation: Baby immunogenicity set
Proportion of newborn babies achieving vaccine specific IgG antibody concentrations above pre-defined arbitrary thresholds (0.5, 1, 2 μg/mL).
Outcome measures
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=26 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=34 Participants
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=7 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=11 Participants
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
Alp1N >2
|
64.0 percentage of newborns babies
Interval 44.5 to 79.8
|
64.5 percentage of newborns babies
Interval 47.0 to 78.9
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
Alp1N >0.5
|
92.0 percentage of newborns babies
Interval 75.0 to 97.8
|
80.7 percentage of newborns babies
Interval 63.7 to 90.8
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
Alp1N >1
|
84.0 percentage of newborns babies
Interval 65.4 to 93.6
|
77.4 percentage of newborns babies
Interval 60.2 to 88.6
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
Alp2N >0.5
|
82.6 percentage of newborns babies
Interval 62.9 to 93.0
|
75.9 percentage of newborns babies
Interval 57.9 to 87.8
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
Alp2N >1
|
73.9 percentage of newborns babies
Interval 53.5 to 87.5
|
72.4 percentage of newborns babies
Interval 54.3 to 85.3
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
Alp2N >2
|
56.5 percentage of newborns babies
Interval 36.8 to 74.4
|
55.2 percentage of newborns babies
Interval 37.6 to 71.6
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
AlpCN >0.5
|
81.8 percentage of newborns babies
Interval 61.5 to 92.7
|
75.9 percentage of newborns babies
Interval 57.9 to 87.8
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
10.0 percentage of newborns babies
Interval 1.8 to 40.4
|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
AlpCN >1
|
68.2 percentage of newborns babies
Interval 47.3 to 83.6
|
75.9 percentage of newborns babies
Interval 57.9 to 87.8
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
AlpCN >2
|
54.6 percentage of newborns babies
Interval 34.7 to 73.1
|
69.0 percentage of newborns babies
Interval 50.8 to 82.7
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
RibN >1
|
64.0 percentage of newborns babies
Interval 44.5 to 79.8
|
66.7 percentage of newborns babies
Interval 48.8 to 80.8
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
RibN >0.5
|
72.0 percentage of newborns babies
Interval 52.4 to 85.7
|
76.7 percentage of newborns babies
Interval 59.1 to 88.2
|
16.7 percentage of newborns babies
Interval 3.0 to 56.4
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
|
Proportion of Newborn Babies Achieving Vaccine Specific IgG Antibody Concentrations
RibN >2
|
48.0 percentage of newborns babies
Interval 30.0 to 66.5
|
56.7 percentage of newborns babies
Interval 39.2 to 72.6
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
0 percentage of newborns babies
Interval 0.0 to 0.0
|
Adverse Events
GBS-NN/NN2 in Pregnant Women Living With HIV
Serious events: 29 serious events
Other events: 62 other events
Deaths: 0 deaths
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
Serious events: 23 serious events
Other events: 61 other events
Deaths: 0 deaths
Placebo Comparator in Pregnant Women Living With HIV
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo Comparator in Pregnant Women Who do Not Have HIV
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=80 participants at risk
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=80 participants at risk
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 participants at risk
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=20 participants at risk
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Fœtal distress syndrome
|
18.8%
15/80 • Number of events 15 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
12.5%
10/80 • Number of events 10 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
15.0%
3/20 • Number of events 3 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
6.2%
5/80 • Number of events 6 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
4/80 • Number of events 4 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged labour
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Failed induction of labour
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
HELLP syndrome
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Anembryonic gestation
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Face presentation
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Foetal malposition
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Obstructed labour
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged pregnancy
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Retained products of conception
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Uterine contractions during pregnancy
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Infections and infestations
Urinary tract infection
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Infections and infestations
Cervicitis
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Infections and infestations
Postpartum sepsis
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Infections and infestations
Sepsis
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Cardiac disorders
Tachycardia
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Psychiatric disorders
Brief psychotic disorder with postpartum onset
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Renal and urinary disorders
Hydronephrosis
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Surgical and medical procedures
Arterial ligation
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Vascular disorders
Hypertension
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
Other adverse events
| Measure |
GBS-NN/NN2 in Pregnant Women Living With HIV
n=80 participants at risk
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women living with HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
GBS-NN/NN2 in Pregnant Women Who do Not Have HIV
n=80 participants at risk
2 doses of 0.5mL intramuscular injection GBS-NN/NN2 containing 50 µg GBS-NN and 50 µg NN2 administered 28 days apart in pregnant women who do not have HIV
GBS-NN/NN2: GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
|
Placebo Comparator in Pregnant Women Living With HIV
n=20 participants at risk
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women living with HIV
Placebo: Normal Saline 0.9%
|
Placebo Comparator in Pregnant Women Who do Not Have HIV
n=20 participants at risk
2 doses of 0.5mL intramuscular injection 0.9% normal saline administered 28 days apart in pregnant women who do not have HIV
Placebo: Normal Saline 0.9%
|
|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
18.8%
15/80 • Number of events 16 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
16.2%
13/80 • Number of events 17 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
15.0%
3/20 • Number of events 3 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
20.0%
4/20 • Number of events 5 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
10.0%
8/80 • Number of events 9 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
8.8%
7/80 • Number of events 7 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Nervous system disorders
Headache
|
11.2%
9/80 • Number of events 13 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
21.2%
17/80 • Number of events 25 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
15.0%
3/20 • Number of events 5 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Infections and infestations
Upper respiratory tract infection
|
31.2%
25/80 • Number of events 42 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
20.0%
16/80 • Number of events 20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
25.0%
5/20 • Number of events 6 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
25.0%
5/20 • Number of events 8 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Infections and infestations
Malaria
|
7.5%
6/80 • Number of events 6 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
7.5%
6/80 • Number of events 6 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Infections and infestations
Gastroenteritis
|
5.0%
4/80 • Number of events 5 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
6.2%
5/80 • Number of events 5 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
20.0%
4/20 • Number of events 5 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Infections and infestations
COVID-19
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
3.8%
3/80 • Number of events 3 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
6.2%
5/80 • Number of events 5 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
4/80 • Number of events 5 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
General disorders
Influenza like illness
|
5.0%
4/80 • Number of events 4 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
3.8%
3/80 • Number of events 3 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
General disorders
Pyrexia
|
0.00%
0/80 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
6.2%
5/80 • Number of events 7 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
6.2%
5/80 • Number of events 5 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
1/20 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.5%
2/80 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
10.0%
2/20 • Number of events 3 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Vascular disorders
Hypertension
|
5.0%
4/80 • Number of events 4 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
5.0%
4/80 • Number of events 4 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
15.0%
3/20 • Number of events 3 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
10.0%
2/20 • Number of events 2 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
1/80 • Number of events 1 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
3.8%
3/80 • Number of events 3 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
15.0%
3/20 • Number of events 3 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
0.00%
0/20 • All adverse events were collected from informed consent signature (Between 24- and 28-weeks of gestation) until end of study (Visit 10: 365±8 day after birth), up to 69 weeks from signing of informed consent form. Maternal Serious Adverse Events (SAEs) will be reported from the day of signing informed consent for study participation to 28 days post-delivery (Visit 6).
|
Additional Information
Cornelia Oostvogels/Chief Medical Officer (CMO)
MinervaX
Phone: 00491515092821
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place