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

NCT06128733

CompletedPhase 1, Phase 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Meningococcal Immunisation, Healthy Volunteers

Interventions: Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine, Meningococcal group B vaccine, Meningococcal group B vaccine, Meningococcal group B vaccine

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 10 Years to 25 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (47)
  • Birmingham, Alabama, United States
  • Guntersville, Alabama, United States
  • Tempe, Arizona, United States
  • Harrisburg, Arkansas, United States
  • Anaheim, California, United States
  • Canoga Park, California, United States
  • Fair Oaks, California, United States
  • Washington D.C., District of Columbia, United States
  • DeLand, Florida, United States
  • Gainesville, Florida, United States
  • Largo, Florida, United States
  • Medley, Florida, United States
  • Miami, Florida, United States
  • Miami Lakes, Florida, United States
  • Orlando, Florida, United States
  • Ormond Beach, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Idaho Falls, Idaho, United States
  • Idaho Falls, Idaho, United States
  • Peoria, Illinois, United States
  • Evansville, Indiana, United States
  • Newton, Kansas, United States
  • Bardstown, Kentucky, United States
  • Lexington, Kentucky, United States
  • Dearborn Heights, Michigan, United States
  • Dearborn Heights, Michigan, United States
  • Lincoln, Nebraska, United States
  • Lincoln, Nebraska, United States
  • + 17 more on CT.gov