A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
NCT07922226, Phase 2, Phase 3, Not yet recruiting, Minervax ApS
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial | ClinicalTrials.gov |
| NCT number | NCT07922226 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2, Phase 3 | ClinicalTrials.gov |
| Enrollment | 6,600 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Minervax ApS | ClinicalTrials.gov |
| Conditions | Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis, Neonatal Infection | ClinicalTrials.gov |
| Interventions | GBS-NN/NN2 vaccine, Placebo | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Phase 2: Geometric Mean Antibody Titres Determined by Opsonophagocytic Killing Activity/Assay (OPkA) in Infant Participants | At birth | Functional antibody titres (determined by \[alpha-like protein expressed on the surface of GBS\] Alp strain-specific \[Rib, Alp1, Alp2/3, and AlphaC\] OPkA) in infant participants at birth. | ClinicalTrials.gov |
| Primary | Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing SAEs | From screening until 6 months after delivery or pregnancy termination (up to approximately 12 months) | ClinicalTrials.gov | |
| Primary | Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing SAEs | From birth to 12 months after birth | ClinicalTrials.gov | |
| Primary | Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing Pregnancy-related AESIs | From screening until 6 weeks after delivery or pregnancy termination (up to approximately 6.5 months) | ClinicalTrials.gov | |
| Primary | Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing Auto-immune AESIs | Day 1 up to 6 months post last vaccination | ClinicalTrials.gov | |
| Primary | Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing AESIs | From birth to 12 months after birth | ClinicalTrials.gov | |
| Primary | Phase 3: Number of Infant Participants with OPkA Antibody Titres Reaching Predefined Alp Strain-specific iGBS EoD Protective Thresholds | At birth | Functional antibody titres (determined by Alp strain-specific \[Rib, Alp1, Alp2/3, and AlphaC\] OPkA) reaching predefined Alp strain-specific iGBS EoD protective thresholds at birth. | ClinicalTrials.gov |
| Primary | Phase 3: Number of Infant Participants with OPkA Antibody Titres Reaching Predefined Alp Strain-specific iGBS LoD Protective Thresholds | At birth | Functional antibody titres (determined by Alp strain-specific \[Rib, Alp1, Alp2/3, and AlphaC\] OPkA) reaching predefined Alp strain-specific iGBS LoD protective thresholds at birth. | ClinicalTrials.gov |
| Secondary | Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing Medically-attended AEs (MAAEs) | up to 1 month (30 days) after delivery or pregnancy termination (up to approximately 12 months) | ClinicalTrials.gov | |
| Secondary | Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing MAAEs | From birth to 6 months of age | ClinicalTrials.gov | |
| Secondary | Phase 2 and Phase 3 (Reactogenicity/Unsolicited AE Subset): Number of Maternal Participants Experiencing Unsolicited AEs | Day 1 to Day 28, and from Day 57 to Day 85 | ClinicalTrials.gov | |
| Secondary | Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing AEs | From birth to 1 month (30 days) of age | ClinicalTrials.gov | |
| Secondary | Phase 2 and Phase 3 (Reactogenicity/Unsolicited AE Subset): Number of Maternal Participants Experiencing Solicited Local and Systemic AEs | Day 1 to Day 7, and from Day 57 to Day 64 | ClinicalTrials.gov | |
| Secondary | Phase 2: Geometric Mean Antibody Titres Determined by OPkA of Infant Participants | 1 month and 3 months of age | ClinicalTrials.gov | |
| Secondary | Phase 2: Concentrations of IgG Antibody Specific to the AlpN Proteins in Blood Serum in Infant Participants | At birth, and at 1 and 3 months of age | Concentrations of IgG antibodies specific to the AlpN proteins (RibN, Alp1N, Alp2/3N, and AlphaCN) in blood serum. | ClinicalTrials.gov |
| Secondary | Phase 2: Number of Seropositive Infant Participants with Quantifiable Functional Antibody Titres Determined by OPkA | At birth, and at 1 and 3 months of age | Infant participants with quantifiable functional antibody titres (determined by Alp strain-specific \[Rib, Alp1, Alp2/3, and AlphaC\] OPkA) against all and each Alp strain. | ClinicalTrials.gov |
| Secondary | Phase 2: Concentrations of IgG Antibody Specific to the AlpN Proteins in Blood Serum in Maternal Participants | Day 1 (pre-dose), 4 weeks after first and second dose of GBS-NN/NN2 vaccine, and at time of delivery | Concentrations of IgG antibodies specific to the AlpN proteins (RibN, Alp1N, Alp2/3N, and AlphaCN) in blood serum. | ClinicalTrials.gov |
| Secondary | Phase 3: Number of Infant Participants with OPkA Antibody Titres Reaching Predefined Alp Strain-specific iGBS Protective Thresholds (EoD and LoD) | At birth | Functional antibody titres (determined by Alp strain-specific \[Rib, Alp1, Alp2/3, and AlphaC\] OPkA) reaching predefined Alp strain-specific invasive group B streptococcus (iGBS) disease protective thresholds (overall, i.e., reaching both EoD and LoD protective thresholds) at birth. | ClinicalTrials.gov |
| Secondary | Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS EoD Caused by any Alp strain | At birth | ClinicalTrials.gov | |
| Secondary | Phase 3: Number of Infant Participants With Alp Strain-specific Functional Antibody OPkA titres-based Predicted Risk of iGBS LoD Caused by any Alp strain | At birth | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)