Trials / Active Not Recruiting
Active Not RecruitingNCT06592586
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
A Follow-up Trial to Assess the Persistence of the Immune Response to the Group B Streptococcus Vaccine (GBS-NN/NN2) After a Primary Vaccination of Healthy Pregnant Women, and to Assess Safety, Reactogenicity, and Immunogenicity of the GBS-NN/NN2 Vaccine When Administered During Follow-Up as a 1 Booster Dose During a New Pregnancy
- Status
- Active Not Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 338 (actual)
- Sponsor
- Minervax ApS · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GBS-NN/NN2 vaccine | 0.5 mL (50 μg GBS-NN +50 μg GBS-NN2 adsorbed to 0.5 mg aluminium as Alhydrogel®) |
Timeline
- Start date
- 2025-03-07
- Primary completion
- 2029-06-30
- Completion
- 2029-06-30
- First posted
- 2024-09-19
- Last updated
- 2026-04-14
Locations
6 sites across 2 countries: Denmark, South Africa
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06592586. Inclusion in this directory is not an endorsement.