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Life sciences · Phase 2/3 Trial
ClinicalTrials.gov · November 6, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2/3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07922226). This is a study registration, not published results. Lead sponsor: Minervax ApS. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 6600 participants (ESTIMATED). Conditions: Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis, Neonatal Infection. Interventions: DRUG: GBS-NN/NN2 vaccine; OTHER: Placebo. Primary outcome measures: Phase 2: Geometric Mean Antibody Titres Determined by Opsonophagocytic Killing Activity/Assay (OPkA) in Infant Participants , At birth; 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); Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing SAEs , From birth to 12 months after birth; 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); Phase 2, Phase 3 and Overall: Number of Maternal Participants Experiencing Auto-immune AESIs , Day 1 up to 6 months post last vaccination; Phase 2, Phase 3 and Overall: Number of Infant Participants Experiencing AESIs , From birth to 12 months after birth; Phase 3: Number of Infant Participants with OPkA Antibody Titres Reaching Predefined Alp Strain-specific iGBS EoD Protective Thresholds , At birth; Phase 3: Number of Infant Participants with OPkA Antibody Titres Reaching Predefined Alp Strain-specific iGBS LoD Protective Thresholds , At birth. Brief summary: The main objective of the Phase 2 part of the trial is to assess the immunogenicity of GBS-NN/NN2 vaccine at birth in infant participants and to determine the occurrence of serious adverse events (SAEs) and adverse event of special interest (AESIs) after GBS-NN/NN2 vaccine administration compared to placebo, in both maternal and infant participants. The main objective of the Phase 3 part of the trial is to assess the ability of GBS-NN/NN2 vaccine to induce functional antibody titres protective against invasive GBS (iGBS) early-onset disease (EoD) in infant participants, to assess the ability of GBS-NN/NN2 vaccine to induce functional antibody titres protective against iGBS late-onset disease (LoD) in infant participants and to determine the occurrence of SAEs and AESIs after GBS-NN/NN2 vaccine administration compared to placebo, in both maternal and infant participants.