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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 is a Phase 1 study that was terminated before completion, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 576 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04825223
The ClinicalTrials.gov registry entry for NCT04825223 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 576 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04825223 reports 0 study locations.
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.
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