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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516364-28 | EudraCT Number |
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The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like protein 2 and 3 (Alp2-3N), after a primary vaccination with GBS-NN/NN2 in all participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Pregnant Participants: No GBS-NN/NN2 Booster Dose | No Intervention | Participants who received at least one dose of GBS-NN/NN2 during the parent studies but do not become pregnant during this study will not receive the GBS-NN/NN2 booster dose. | |
| Pregnant Participants: GBS-NN/NN2 Booster Dose | Experimental | Participants who received at least one dose of GBS-NN/NN2 during the parent studies and, become pregnant during this study, and qualify, will receive become pregnant during this study will receive the GBS-NN/NN2 booster dose. |
|
| Pregnant Participants: No GBS-NN/NN2 Booster Dose | No Intervention | Participants who received at least one dose of GBS-NN/NN2 during the parent studies and, become pregnant during this study but do not qualify for receiving the GBS-NN/NN2 booster dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBS-NN/NN2 vaccine | Biological | 0.5 mL (50 μg GBS-NN +50 μg GBS-NN2 adsorbed to 0.5 mg aluminium as Alhydrogel®) |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of IgG Antibodies to AlpN Proteins in Blood Serum Following GBS-NN/NN2 Booster Dose | Pre-dose, 1 month pots-dose, at delivery, and 6 months post-delivery | |
| Difference in Concentration of IgG Antibodies Between Maternal and Cord Blood at Delivery Following GBS-NN/NN2 Booster Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre Hospital - Department Of Obstetrics And Gynaecology | Copenhagen | Capital Region | 2650 | Denmark | ||
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| Up until delivery, approximately 5 years |
| Concentration of IgG Antibodies to AlpN Proteins in Blood Serum at Delivery in the Absence of GBS-NN/NN2 Booster Dose | Up until delivery, approximately 5 years |
| Difference in Concentration of IgG Antibodies Between Maternal and Cord Blood at Delivery in the Absence of GBS-NN/NN2 Booster Dose | Up until delivery, approximately 5 years |
| Concentration of IgG Antibody to AlpN Proteins in Blood Serum of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | At delivery and at 1 and 3 months post-birth |
| Concentration of IgG Antibody to AlpN Proteins in Cord Blood of Offspring from Pregnant Participants who did not Received the GBS-NN/NN2 Booster Dose | Up until birth, approximately 5 years |
| All Participants: Number of Participants Experiencing Procedure-related Serious Adverse Events (SAEs) | Up to approximately 5 years |
| Number of Participants Experiencing Solicited Local and Systemic Adverse Events (AEs) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to approximately Day 7 |
| Number of Participants Experiencing Unsolicited AEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to approximately Day 28 |
| Number of Participants Experiencing SAEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to approximately 6 months post-delivery |
| Number of Participants Experiencing AE of Special Interest (AESI) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up until delivery, approximately 5 years |
| Gestational Age (GA) of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up until birth, approximately 5 years |
| Weight of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up until birth, approximately 5 years |
| Length of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up until birth, approximately 5 years |
| Head Circumference of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up until birth, approximately 5 years |
| Apgar Score of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up until birth, approximately 5 years |
| Number of Offspring Experiencing Unsolicited AEs from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to 1 month post-birth, approximately 5 years |
| Developmental Milestones of Offspring from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose as Assessed by the Ages & Stages Questionnaire, 3rd Edition (ASQ-3) | At 6 months post-birth, approximately 5 years |
| Number of Offspring Experiencing Medically-attended AEs (MAAEs) from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to 6 months post-birth, approximately 5 years |
| Number of Offspring Experiencing SAEs from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to 6 months post-birth, approximately 5 years |
| Number of Offspring Experiencing AESIs from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose | Up to 6 months post-birth, approximately 5 years |
| Aarhus Universitetshospital |
| Aarhus N |
| Central Jutland |
| 8200 |
| Denmark |
| Sygehus Lillebælt - Kolding Sygehus | Kolding | Region Syddanmark | 6000 | Denmark |
| Sefako Makgatho Health Sciences University, Medunsa Clinical Research Unit (MeCRU) | Ga-Rankuwa | Gauteng | 0204 | South Africa |
| Wits Reproductive Health and HIV Institute (Wits RHI) | Johannesburg | Guateng Province | 2001 | South Africa |
| Setshaba Research Centre | Pretoria | Guateng Province | 0152 | South Africa |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D000071074 | Neonatal Sepsis |
| D011014 | Pneumonia |
| D008581 | Meningitis |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
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