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| Name | Class |
|---|---|
| Larix A/S | INDUSTRY |
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This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women. There will be 5 treatment groups; three groups of 60 participants will receive will receive two doses of GBS-NN/NN2 vaccine and one dose of placebo (saline); one group of 60 participants will receive one dose of GBS-NN/NN2 vaccine and two doses of placebo (saline), and one group of 30 participants will receive three doses of placebo (saline).
This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women. There will be 5 treatment groups; Group 1 will receive one injection of placebo at 22 (±1) weeks gestational age (GA), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA. Group 2 will receive one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA.Group 3 will receive one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA. Group 4 will receive one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA.
Group 5 will receive an injection of placebo at 22, 26 and 30 weeks (±1) GA. Participants will attend the clinic for assessment visits up to delivery and for a further 3 visits at 28 (±4) days, 90 (±6) days and 180 (±14) days post delivery.
Babies will be also be assessed at delivery, and 28 (±4) days, 90 (±6) days and 180 (±14) days post delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 4 week dose interval; 2 doses | Experimental | Participants will receive one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA |
|
| Group 2: early intervention; 4 week dose interval; 2 doses | Experimental | Participants will receive one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA |
|
| Group 3: early intervention; 8 week dose interval; 2 doses | Experimental | Participants will receive one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA |
|
| Group 4: single dose | Experimental | Participants will receive one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA. |
|
| Group 5: placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBS-NN/NN2 Vaccine | Biological | 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby at birth. | Delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Injection Site Reactions in the Mother | Number of participants with solicited injection site reactions following vaccination | 7 days following each injection |
| Adverse Events Following the Vaccinations in the Mother |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jeannett Dimsits | jdi@minervax.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital; Skejby | Aarhus | Denmark | ||||
| Hvidovre University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41386262 | Derived | Heath PT, Zuma-Gwala N, Helmig RB, Horne E, Kjaerbye-Thygesen A, Crusell MKW, Nchabeleng M, Strehlau R, Khalil MR, Jones CE, Biccler J, Dimsits J, Johansson-Lindbom B, Fischer PB, Oostvogels L, Madhi SA; MVX0004 study group. Immunogenicity and safety of a group B Streptococcus vaccine (GBS-AlpN) in pregnant women and their infants: a phase 2, multicentre, observer-blind, randomised, placebo-controlled study. Lancet Infect Dis. 2026 May;26(5):486-496. doi: 10.1016/S1473-3099(25)00659-0. Epub 2025 Dec 9. |
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A total of 269 maternal participants were enrolled in the study and randomised to one of the 5 study groups.
The first participant first visit took place on 17 February 2022 and the last participant last visit took place on 18 October 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 4 Week Dose Interval; 2 Doses | Participants received one injection of placebo at 22 (±1) weeks GA (gestational age), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection |
| FG001 | Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses | Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection |
| FG002 | Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses | Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection |
| FG003 | Group 4: Single Dose | Participants received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA. GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection |
| FG004 | Group 5: Placebo | Participants received one injection of placebo at 22, 26 and 30 weeks (±1) GA Placebo: 0.5 mL normal saline given by intramuscular injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: 4 Week Dose Interval; 2 Doses | Participants received one injection of placebo at 22 (±1) weeks GA (gestational age), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby | Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in cord blood from each baby at birth. | Baby Immunogenicicty Set : babies with at least one evaluable sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Delivery |
|
Treatment-emergent Adverse Events (TEAEs) in the mother were assessed from the time of informed consent until Day 84. From delivery onwards, only Medically attended adverse events (MAAEs), Adverse events of special interest (AESIs) and Serious adverse events (SAEs) were assessed until the end of study (corresponding to 166-194 days post-delivery). For the infants, all AEs were assessed for the first 28 days of life. Afterward, only MAAEs, AESIs and SAEs were assessed until the end of study.
Solicited local and systemic reactions were collected in electronic diaries up to 7 days following each administered vaccination. In addition, other AEs, i.e., unsolicited AEs, including MAAEs, SAEs, concomitant medication or vaccines were to be recorded in the electronic diary.
AEs were also collected following laboratory safety tests, physical examinations and vital signs performed at the study visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 (Mothers): 4 Week Dose Interval; 2 Doses | Participants received one injection of placebo at 22 (±1) weeks GA (gestational age), one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cornelia Oostvogels/Chief Medical Officer (CMO) | MinervaX | 00491515092821 | lio@minervax.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2023 | Oct 15, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2023 | Oct 15, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Participants will be randomized to one of 5 groups
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Participants will receive one injection of placebo at 22, 26 and 30 weeks (±1) GA |
|
| Placebo | Biological | 0.5 mL normal saline given by intramuscular injection |
|
|
Number of participants with solicited and other adverse events following the vaccinations
| To Day 84 |
| Clinically Significant Abnormal Laboratory Tests in the Mother | Number of participants with clinically significant abnormal laboratory tests in the mother | To Day 84 |
| Clinically Significant Changes in Vital Signs in the Mother | Number of participants with clinically significant changes in vital signs (heart rate, blood pressure, oral temperature) in the mother | To Day 84 |
| Clinically Significant Changes in Physical Examination in the Mother | Number of participants with clinically significant changes in physical examination in the mother | To Day 84 |
| Gestational Age | Gestational age at birth | Delivery |
| Weight of the Baby | Weight of the baby | Delivery |
| Length of the Baby | Length of the baby | Delivery |
| Head Circumference of the Baby | Head circumference of the baby | Delivery |
| Apgar Score in the Baby | Apgar score in the baby (Appearance; Pulse; Grimace response; Activity; Respiration). Range 0 to 10 where high scores are good and low scores are bad. | 1, 5 and 10 minutes |
| Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in maternal blood | Delivery |
| Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in blood from each baby | 1 month, 3 months |
| Hvidovre |
| Denmark |
| Institut for Regional Sundhedsforskning | Kolding | Denmark |
| ESRU Rahima Moosa Mother and Child Hospital | Johannesburg | South Africa |
| Shandukani Research Clinic | Johannesburg | South Africa |
| Wits Vaccines & Infectious Diseases Analytics | Johannesburg | South Africa |
| Mecru Clinical Research Unit (MeCRU) | Pretoria | South Africa |
| Setshaba Research Centre | Pretoria | South Africa |
| St George's University Hospital | London | United Kingdom |
| University Hospital Southampton | Southampton | United Kingdom |
| Lost to Follow-up |
|
| Adverse Event |
|
| Relocated to another province |
|
| Baby loss |
|
| BG001 | Group 2: Early Intervention; 4 Week Dose Interval; 2 Doses | Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection |
| BG002 | Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses | Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection |
| BG003 | Group 4: Single Dose | Participants received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA. GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection |
| BG004 | Group 5: Placebo | Participants received one injection of placebo at 22, 26 and 30 weeks (±1) GA Placebo: 0.5 mL normal saline given by intramuscular injection |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m² |
|
Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA |
| OG002 | Group 3: Early Intervention; 8 Week Dose Interval; 2 Doses (Infant Participants) | Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA |
| OG003 | Group 4: Single Dose (Infant Participants) | Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA |
| OG004 | Group 5: Placebo (Infant Participants) | Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA |
|
|
| Secondary | Injection Site Reactions in the Mother | Number of participants with solicited injection site reactions following vaccination | Posted | Number | participants | 7 days following each injection |
|
|
|
| Secondary | Adverse Events Following the Vaccinations in the Mother | Number of participants with solicited and other adverse events following the vaccinations | Posted | Number | participants | To Day 84 |
|
|
|
| Secondary | Clinically Significant Abnormal Laboratory Tests in the Mother | Number of participants with clinically significant abnormal laboratory tests in the mother | Posted | Number | participants | To Day 84 |
|
|
|
| Secondary | Clinically Significant Changes in Vital Signs in the Mother | Number of participants with clinically significant changes in vital signs (heart rate, blood pressure, oral temperature) in the mother | Posted | Number | participants | To Day 84 |
|
|
|
| Secondary | Clinically Significant Changes in Physical Examination in the Mother | Number of participants with clinically significant changes in physical examination in the mother | Posted | Number | participants | To Day 84 |
|
|
|
| Secondary | Gestational Age | Gestational age at birth | Baby safety analysis set | Posted | Mean | Standard Deviation | weeks | Delivery |
|
|
|
| Secondary | Weight of the Baby | Weight of the baby | Baby safety analysis set | Posted | Mean | Standard Deviation | grams | Delivery |
|
|
|
| Secondary | Length of the Baby | Length of the baby | Baby safety analysis set | Posted | Mean | Standard Deviation | centimeters | Delivery |
|
|
|
| Secondary | Head Circumference of the Baby | Head circumference of the baby | Baby safety analysis set | Posted | Mean | Standard Deviation | centimeters | Delivery |
|
|
|
| Secondary | Apgar Score in the Baby | Apgar score in the baby (Appearance; Pulse; Grimace response; Activity; Respiration). Range 0 to 10 where high scores are good and low scores are bad. | Baby safety analysis set | Posted | Mean | Standard Deviation | score on a scale | 1, 5 and 10 minutes |
|
|
|
| Secondary | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Maternal Blood | Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in maternal blood | Baby Immunogenicicty Set : babies with at least one evaluable sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Delivery |
|
|
|
| Secondary | Concentrations of IgG Antibodies Specific to the AlpN Proteins in μg/mL in Blood From Each Baby | Concentrations of IgG antibodies specific to the AlpN proteins in μg/mL in blood from each baby | Baby Immunogenicicty Set : babies with at least one evaluable sample. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | 1 month, 3 months |
|
|
|
| 0 |
| 61 |
| 23 |
| 61 |
| 56 |
| 61 |
| EG001 | Group 2 (Mothers): Early Intervention; 4 Week Dose Interval; 2 Doses | Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection | 0 | 59 | 12 | 59 | 54 | 59 |
| EG002 | Group 3 (Mothers): Early Intervention; 8 Week Dose Interval; 2 Doses | Participants received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection | 0 | 59 | 20 | 59 | 57 | 59 |
| EG003 | Group 4 (Mothers): Single Dose | Participants received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA. GBS-NN/NN2 Vaccine: 0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection. Placebo: 0.5 mL normal saline given by intramuscular injection | 0 | 60 | 25 | 60 | 56 | 60 |
| EG004 | Group 5 (Mothers): Placebo | Participants received one injection of placebo at 22, 26 and 30 weeks (±1) GA Placebo: 0.5 mL normal saline given by intramuscular injection | 0 | 30 | 14 | 30 | 26 | 30 |
| EG005 | Group 1 (Infants): 4 Week Dose Interval; 2 Doses | Infants of participants from group 1, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA | 2 | 61 | 15 | 61 | 43 | 61 |
| EG006 | Group 2 (Infants): Early Intervention; 4 Week Dose Interval; 2 Doses | Infants of participants from group 2, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA and one injection of placebo at 30 (±1) weeks GA | 2 | 58 | 13 | 58 | 38 | 58 |
| EG007 | Group 3 (Infants): Early Intervention; 8 Week Dose Interval; 2 Doses | Infants of participant of group 3, who received one injection of GBS-NN/NN2 at 22 (±1) weeks GA, one injection of placebo at 26 (±1) weeks GA and one injection of GBS- NN/NN2 at 30 (±1) weeks GA | 1 | 58 | 16 | 58 | 38 | 58 |
| EG008 | Group 4 (Infants): Single Dose | Infants of participants from group 4, who received one injection of placebo at 22 (±1) weeks GA, one injection of GBS-NN/NN2 at 26 (±1) weeks GA, and one injection of placebo at 30 (±1) weeks GA | 3 | 57 | 17 | 57 | 45 | 57 |
| EG009 | Group 5 (Infants): Placebo | Infant of participants from group 5, who received one injection of placebo at 22, 26 and 30 weeks (±1) GA | 1 | 29 | 7 | 29 | 21 | 29 |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Prolonged labour | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Foetal Growth restriction | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| HELLP syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| False labour | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Foetal hypokinesia | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Intrapartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Placenta praevia | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Amniorrhoea | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Cephalo-pelvic disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Failed induction of labour | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Foetal macrosomia | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Foetal vascular malperfusion | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Large for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Prolonged pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Prolonged rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Retroplacental haematoma | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Uterine hypotonus | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Meconium in amniotic fluid | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Placental insufficiency | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Amniotic cavity infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Bacterial vaginosis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Endometritis decidual | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Postpartum sepsis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Bradycardia foetal | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Perineal injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Acute kidney inury | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Foetal monitoring abnormal | Investigations | MedDRA 24.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Artificial rupture of membranes | Surgical and medical procedures | MedDRA 24.1 | Non-systematic Assessment |
|
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Sepsis neonatal | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Talipes | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Birth mark | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Cleft palate | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Congenital skin dimples | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Epidermolysis bullosa | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hypospadias | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Supernumerary nipple | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Infantile fibromatosis | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Bone metabolism disorder | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Congenital naevus | Congenital, familial and genetic disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Weight decrease neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Fungal sepsis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Neonatal infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Lower respiratory tract infection viral | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Meningitis neonatal | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Neonatal pneumonia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Chronic respiratory disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Neonatal respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Transient tachypnoea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Meconium aspiration syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Upper airway obstruction | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Underweight | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Neonatal hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Weight gain poor | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Thrombocytopenia neonatal | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Prerenal failure | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Necrotising enterocolitis neonatal | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Food protein-induced enterocolitis syndrome | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Necrotising colitis | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Body height below normal | Investigations | MedDRA 24.1 | Non-systematic Assessment |
|
| Tympanometry abnormal | Investigations | MedDRA 24.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA 24.1 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 24.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Intraventricular haemorrhage neonatal | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Encephalopathy neonatal | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Retinopathy of prematurity | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Developmental regression | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Drug withdrawal syndrome neonatal | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Streptococcal urinary tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Foetal hypokinesia | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Prolonged pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Uterine contractions during pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Jaundice Neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
Not provided
Not provided
|
|
|
| Redness : 2.5 - 5.0 cm |
|
| Redness : 5.1 - 10.0 cm |
|
| Redness : >10 cm |
|
| Swelling : Palpable "firmness" only |
|
| Swelling : 0 - 2.4 cm |
|
| Swelling : 2.5 - 5.0 cm |
|
| Swelling : 5.1 - 10.0 cm |
|
| Tenderness: Mild |
|
| Tenderness: Moderate |
|
| Tenderness: Severe |
|
| Itching |
|
| Pain: Mild |
|
| Pain: Moderate |
|
| Pain: Severe |
|
| APGAR score at 5 minutes |
|
| APGAR score at 10 minutes |
|
|
| Alp2N |
|
|
| AlpCN |
|
|
| RibN |
|
|
|
| Alp1N: At 3 months of age |
|
|
| Alp2N: At 1 month of age |
|
|
| Alp2N: At 3 months of age |
|
|
| AlpCN: At 1 month of age |
|
|
| AlpCN: At 3 months of age |
|
|
| RibN: At 1 month of age |
|
|
| RibN: At 3 months of age |
|
|