Active — Not RecruitingPhase 3

Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers

Finland, Germany, Hungary209 participantsStarted 2022-08-23

Plain-language summary

The purpose of the MEQ00073 study is to assess the immunogenicity and safety of a booster dose in children who had been vaccinated with MenACYW conjugate vaccine approximately 5 years earlier as toddlers as part of the MET51 study, and to describe the persistence of a priming dose in children and adolescents who had been vaccinated with MenACYW conjugate vaccine approximately 5 years or 10 years earlier as toddlers as part of the MET51 study, the immunogenicity and safety of a booster dose in adolescents who had been primed with MenACYW conjugate vaccine as toddlers as part of the MET51 study, and the immunogenicity and safety of a second booster dose in adolescents approximately 5 years after a first booster dose as children approximately 5 years after the priming dose as toddlers.

Who can participate

Age range

6 Years – 7 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: * Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2) * Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures * Covered by health insurance, if required by local regulations Exclusion Criteria: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * History of meningococcal infection, confirmed either clinically, serologically, or microbiologically * At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease) * Personal history of Guillain-Barré syndrome (GBS) * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances * Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intra…

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

Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose

Timeframe: Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose

Trial details

NCT IDNCT04936685

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-09

Results submitted2024-02-22

View on ClinicalTrials.gov More Meningococcal Immunisation trials