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

Phase 1

• Conditions: Bacterial infections and mycoses; MedDRA version: 20.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2023-000924-13-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-21
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 1000
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified