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

Investigation of an investigational meningococcal vaccine in adolescents and adults

Recruiting
10 years - 25 years
All
Phase 1/2
1220 participants needed
45 Locations

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, Meningococcal Infection
  • 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 18 Jun 2024. Study ID: NCT06128733

This study investigates the safety and immune response of an investigational vaccine designed to protect against five types of meningococcal bacteria, which can cause serious infections. The study will involve both adolescents and adults.

Participants will receive the investigational vaccine and will be monitored for safety and immune response. The study will include medical evaluations and assessments to ensure participant safety.

  • Who can participate: The study is open to healthy individuals aged 10 to 25 years. Participants must not have received a MenACWY vaccine in the last 4 years or be unvaccinated. Key exclusion criteria include a history of meningococcal infections or certain health conditions like tuberculosis or Guillain-Barré syndrome.
  • Study details: Participants will receive the investigational vaccine and undergo regular health checks to monitor their response. The study will assess the vaccine's safety and ability to provoke an immune response.
  • Study Timelines: The study will last 12 months.

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