A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
NCT06592586 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 338
Last updated 2026-04-14
Summary
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.
Conditions
- Streptococcus Agalactiae Infection
- Neonatal Sepsis
- Pneumonia
- Meningitis
- Neonatal Infection
- Gram-Positive Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Infections
Interventions
- BIOLOGICAL
-
GBS-NN/NN2 vaccine
0.5 mL (50 μg GBS-NN +50 μg GBS-NN2 adsorbed to 0.5 mg aluminium as Alhydrogel®)
Sponsors & Collaborators
-
Minervax ApS
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-07
- Primary Completion
- 2029-06-30
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- Denmark
- South Africa
Study Locations
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