Status:
COMPLETED
Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningococcal Immunisation
Healthy Volunteers
Eligibility:
All Genders
10-25 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
The study duration will be approximately 12 months for all participants
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2025
Estimated Enrollment :
1215 Patients enrolled
Trial Details
Trial ID
NCT06128733
Start Date
October 31 2023
End Date
July 21 2025
Last Update
August 29 2025
Active Locations (47)
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1
Accel Research Site - Birmingham Clinical Research Unit- Site Number : 8400080
Birmingham, Alabama, United States, 35216
2
Lakeview Clinical Research Site Number : 8400029
Guntersville, Alabama, United States, 35976-2206
3
Alliance for Multispecialty Research- Phoenix- Site Number : 8400056
Tempe, Arizona, United States, 85281
4
Harrisburg Family Medical Center Site Number : 8400070
Harrisburg, Arkansas, United States, 72432