6 completed, 1 active not recruiting, 1 terminated, 1 withdrawn. 4 Phase 1, 4 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 4 | Completed 4 |
| Phase 2 | 4 | Completed 2, Active not recruiting 1, Withdrawn 1 |
| Phase 3 | 2 | Active not recruiting 1, Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women GBS-NN/NN2 vaccine - Streptococcus Agalactiae Infection, Neonatal Sepsis | Phase 2 / Phase 3 | Active not recruiting | Minervax ApS | 137 | 2025-03-07 | 2026-09-04 |
| GBS-NN/NN2 (50 µg of Each Fusion Protein [GBS-NN and GBS-NN2] in Combination With 500 µg Aluminum as Alhydrogel®) Given With and Without the Tdap Vaccine in Healthy Non-pregnant Women 18 to 49 Years of Age GBS-NN/NN2 vaccine, Tdap vaccine, Placebo - Streptococcus Agalactiae Infection | Phase 2 / Phase 3 | Withdrawn | Minervax ApS | 2024-12-17 | 2026-10-13 | |
| A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy Volunteers GBS-NN/NN2 - Group B Streptococcus Infection | Terminated | Minervax ApS | 29 | 2024-01-18 | 2026-02-25 | |
| Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants GBS-NN/NN2, Placebo - Group B Streptococcal Infections | Phase 1 | Completed | Minervax ApS | 90 | 2023-03-01 | 2025-09-05 |
| Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women GBS-NN/NN2 Vaccine, Placebo - Group B Streptococcal Infection | Phase 2 | Completed | Minervax ApS | 269 | 2022-02-17 | 2025-06-11 |
| Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine GBS-NN/NN2 - Group B Streptococcus Infection | Phase 1 | Completed | Minervax ApS | 27 | 2021-08-17 | 2024-10-10 |
| Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV GBS-NN/NN2, Placebo - Group B Streptococcal Infection | Phase 2 | Completed | Minervax ApS | 200 | 2020-11-19 | 2026-07-14 |
| Group B Streptococcus Vaccine in Healthy Females GBS-NN/NN2 with Alhydrogel® 25, Placebo GBS-NN/NN2 with Alhydrogel® 25, Placebo GBS-NN/NN2 with Alhydrogel® 50 - Group B Strep Infection | Phase 1 | Completed | Minervax ApS | 60 | 2019-01-09 | 2021-02-02 |
| Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age. GBS-NN vaccine - Infection by Streptococcus Group B | Phase 1 | Completed | Minervax ApS | 240 | 2015-05-01 | 2021-01-14 |
Streptococcal Infections (6) · Bacterial Infections (1) · Bacterial Infections and Mycoses (1) · Gram-Positive Bacterial Infections (1) · Infections (1) · Meningitis (1) · Neonatal Sepsis (1) · Pneumonia (1)
Boostrix (1) · Saline Solution (1)
United Kingdom (5) · South Africa (3) · Denmark (2) · Belgium (1) · Uganda (1)
Geoff Kitson (3) · Cornelia Oostvogels (1) · Ebbe Englev (1) · Jeannett Dimsits (1) · Per Fisher, PM/CEO (1)
PMID 34215454, PMID 35243418, PMID 38190492, PMID 41386262
2014 (1), 2017 (1), 2023 (1)