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

NCT06834100 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-12-29

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • NPO Petrovax

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-12
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06834100 on ClinicalTrials.gov