CompletedPhase 1/2

Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents

United States, Puerto Rico1,215 participantsStarted 2023-10-31

Plain-language summary

The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents. The study duration will be up to 12 months for all participants.

Who can participate

Age range

10 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: - Aged 18 to 25 years or 10 to 17 years on the day of inclusion * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator. * Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine at least 4 years prior to study enrollment Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency * History of any Neisseria meningitidis infection * At high risk for meningococcal infection during the study * Individuals with active tuberculosis * History of Guillain-Barré syndrome * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with immediate adverse events (AEs)

Timeframe: Within 30 minutes after each vaccination

Number of participants with solicited injection site reactions or systemic reactions

Timeframe: Within 7 days after each vaccination

Number of participants with unsolicited AEs

Timeframe: Within 30 days after each vaccination

Number of participants with serious adverse events (SAEs)

Timeframe: From baseline up to 12 months

Number of participants with medically attended adverse events (MAAEs)

Timeframe: From baseline up to 12 months

Number of participants with out-of-range biological test results

Timeframe: Before each vaccination up to 7 days after primary vaccination visits in the sentinel cohorts (the first 5 participants enrolled in each vaccine group) of each age group

hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second dose in adolescent participants

Trial details

NCT IDNCT06128733

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-27

View on ClinicalTrials.gov More Meningococcal Immunisation trials

Who can participate

Age range

10 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with immediate adverse events (AEs)

Timeframe: Within 30 minutes after each vaccination

Number of participants with solicited injection site reactions or systemic reactions

Timeframe: Within 7 days after each vaccination

Number of participants with unsolicited AEs

Timeframe: Within 30 days after each vaccination

Number of participants with serious adverse events (SAEs)

Timeframe: From baseline up to 12 months

Number of participants with medically attended adverse events (MAAEs)

Timeframe: From baseline up to 12 months

Number of participants with out-of-range biological test results

Timeframe: Before each vaccination up to 7 days after primary vaccination visits in the sentinel cohorts (the first 5 participants enrolled in each vaccine group) of each age group

hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second dose in adolescent participants