Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants

ClinicalTrials.gov ID: NCT04825223

Public ClinicalTrials.gov record NCT04825223. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Safety and Immunogenicity of an Investigational Multicomponent Meningococcal Group B Vaccine in Adults, Adolescents, Toddlers, and Infants

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 response following primary series at D366, and immune response 1 month after a booster dose of the SP MenB vaccine given 1-year post-dose 1 (at D366) in a subset of adults and adolescents in Stage 2 who received SP MenB vaccine formulations, Bexsero Vaccine or Trumenba Vaccine as measured by hSBA in the primary panel of MenB strains by age group * To describe the immune response against meningococcal serogroups A, C, W and Y measured with hSBA in participants from each agegroup receiving MenQuadfi Vaccine

Study identification

NCT ID: NCT04825223
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 1
Lead sponsor: Sanofi Pasteur, a Sanofi Company; Industry
Enrollment: 576 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 42 Days to 50 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 28, 2021
Primary completion: Jul 21, 2022
Completion: Jul 21, 2022
Last update posted: Oct 9, 2025

2021 – 2022

United States locations

U.S. sites: 8
U.S. states: 7
U.S. cities: 8

Facility	City	State	ZIP	Site status
Lakeview Clinical Research Site Number : 8400029	Guntersville	Alabama	35976-2206	—
California Research Foundation Site Number : 8400005	San Diego	California	92123-1881	—
PAS Research Site Number : 8400032	Tampa	Florida	33613	—
Brengle Family Medicine Site Number : 8400044	Indianapolis	Indiana	46260	—
AMR El Dorado Site Number : 8400018	El Dorado	Kansas	67042	—
Alliance for Multispecialty Research LLC Site Number : 8400013	Wichita	Kansas	67205	—
Prime Global Research, Inc. Site Number : 8400043	The Bronx	New York	10456	—
The Research Center of the Upstate Site Number : 8400008	Greenville	South Carolina	29607	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04825223, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 9, 2025 · Synced Sep 2, 2026

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