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

Investigating the Safety and Immune Response of a Meningococcal (a type of bacteria that can cause serious infections) Vaccine

Not Recruiting
10 years - 25 years
All
Phase 1/2
1220 participants needed

Study Overview

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.

Study Details

The study duration will be approximately 12 months for all participants

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Meningococcal Immunisation, Healthy Volunteers
  • Age: 10 years - 25 years
  • Gender: All

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.

Updated on 25 Mar 2025. Study ID: NCT06128733

This study investigates the safety and immune response to an investigational meningococcal vaccine in adolescents and adults. Meningococcal disease is a serious illness caused by bacteria that can lead to infections of the brain and spinal cord. The study aims to evaluate how well the vaccine works in preventing these infections.

Participants will receive either the investigational vaccine or a placebo. A placebo is an inactive substance that looks like the investigational vaccine but does not contain any medicine. The study will monitor participants' health through medical evaluations and check how their immune system responds to the vaccine.

  • Who can participate: Healthy participants aged 10 to 25 years who are either unvaccinated or received a MenACWY vaccine over 4 years ago may join. Those with immunodeficiency or a history of meningococcal infection cannot participate.
  • Study details: Participants will receive either the investigational vaccine or a placebo. Participants' health and immune response will be monitored throughout the study.
  • Study Timelines: The study will last 12 months.