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NCT04825223 · ClinicalTrials.gov registry record · Phase 1
Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants
A Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 576
- Enrollment target
NCT04825223: Clinical Trial Phase 1 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT04825223 is a Phase 1 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 576 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (860% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04825223, a Phase 1 study, was terminated before completion, sponsored by Sanofi Pasteur, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 576 participants
- Enrollment target
Study Summary
Primary Objective: * To describe the safety profile of the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines in healthy adults, adolescents, toddlers and infants, when administered alone (Stages 1-4) or concomitantly with MenQuadfiTM (MenACYW conjugate vaccine) (for Stages 2-4 only), and with age-appropriated routine pediatric vaccines (for Stages 3-4 only) 1. To describe the safety profile of the SP MenB vaccine formulations, Bexsero Vaccine and Trumenba Vaccine in healthy adults, and adolescents; 2. To describe the safety profile of the SP MenB vaccine formulations and Bexsero Vaccine in toddlers and infants; 3. To describe the safety profile of the SP MenB vaccine formulations, * when administered alone * when administered with MenQuadfiTM (MenACYW conjugate vaccine) * when administered with routine infant immunizations * To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines after the last dose of primary vaccination in healthy adults, adolescents, toddlers and infants, when administered alone, or concomitantly with MenQuadfi Vaccine or other routine vaccines, as measured by the serum bactericidal assay using human complement (hSBA) in the primary panel of MenB strains by Stage, by age group and by vaccine schedule Secondary Objective: * To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines at each timepoint in healthy adults, adolescents, toddlers and infants, when administered alone or concomitantly with MenQuadfi Vaccine or other routine vaccines as measured by hSBA in the primary panel of MenB strains by Stage by age group and by vaccine schedule * To describe the immune response (breadth of coverage) in the secondary panel of MenB strains in participants (adults and adolescents) in Stage 1 and 2 after the last dose of the primary series in each group * To describe the persistence of immune respon
Primary Outcome
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Interventions
- DRUG Placebo
- DRUG Multicomponent Meningococcal B Vaccine
- DRUG Meningococcal Group B Vaccine MenB
- DRUG Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)
- DRUG Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 576 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2022-07-22 |
| Phase | Phase 1 |
Why NCT04825223 stopped before completion
NCT04825223 is an interventional study that assigns participants to a tested intervention. The registered 576 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (860% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04825223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04825223 about?
NCT04825223 is a clinical study titled "Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants". Primary Objective: * To describe the safety profile of the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines in healthy adults, adolescents, toddlers and infants, when administered alone (Stages 1-4) or concomitantly with MenQuadfiTM (MenACYW conjugate vaccine) (for Stages 2-...
What is the current status of trial NCT04825223?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 576 participants. The study started on 2021-03-29. Estimated completion is 2022-07-22.
What interventions are being tested in trial NCT04825223?
The interventions under investigation include: Placebo (DRUG), Multicomponent Meningococcal B Vaccine (DRUG), Meningococcal Group B Vaccine MenB (DRUG), Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) (DRUG), Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine (DRUG).
Who is sponsoring clinical trial NCT04825223?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04825223's enrollment target sits among peer trials
576 32nd of 2000 higher than 1,969 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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