NCT06128733

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

A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity Study to Assess Pentavalent Meningococcal ABCYW Vaccine Formulations in Adults (18 to 25 Years of Age) and Adolescents (10 to 17 Years of Age).

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,215 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Accepted

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 months for all participants.

Detailed description

The study duration will be approximately 12 months for all participants

Conditions

• Meningococcal Immunisation
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Pentavalent Meningococcal ABCYW vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)
BIOLOGICAL	MenACYW conjugate vaccine	Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)
BIOLOGICAL	Meningococcal group B vaccine	Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)
BIOLOGICAL	Meningococcal group B vaccine	Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)
BIOLOGICAL	Meningococcal group B vaccine	Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)
BIOLOGICAL	MenACYW conjugate vaccine	Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM)
BIOLOGICAL	Placebo	Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)
BIOLOGICAL	MenABCYW conjugate vaccine	Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

Timeline

• Start date: 2023-10-31
• Primary completion: 2025-08-27
• Completion: 2025-08-27
• First posted: 2023-11-13
• Last updated: 2026-01-13

Locations

47 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study