NCT06834100

Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug

Simple Blinded Multicenter Randomized Comparative Study to Assess Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: NPO Petrovax · Industry
• Sex: All
• Age: 3 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug

Conditions

• Infections
• Meningococcal

Interventions

Type	Name	Description
DRUG	polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y	Group 1 (n = 40) will receive GNG-DE at a dose of 0.5 mL intramuscularly into the deltoid site. Group 2 (n = 40) will receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.

Timeline

• Start date: 2025-02-12
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-02-19
• Last updated: 2025-12-29

Locations

17 sites across 1 country: Russia