Phase 3 Study Comparing the Safety and Immune Response of GNG-DE and Menactra Vaccines for Preventing Meningococcal Infection in Children, Adolescents, and Adults Aged 3 to 55 Years

What this Trial Is About

Researchers are evaluating the immune response, side effects, and safety of a vaccine called GNG-DE compared to a reference vaccine for preventing meningococcal infections. This phase 3 trial is conducted by NPO Petrovax and involves healthy volunteers aged 3 to 55 years. The study is divided into three stages to include adults, adolescents, and children sequentially, with each stage beginning after safety review of the previous stage. Participants are randomly assigned to one of two groups to receive either GNG-DE or the reference vaccine Menactra, both given as 0.5 mL injections into the muscle of the upper arm. The study starts with adults aged 18 to 55 years, then moves to adolescents aged 11 to 17 years, and finally to children aged 3 to 10 years. Each group includes 80 participants, and the dosing and administration are consistent across all age groups. Throughout the study, volunteers undergo screening before enrollment and attend scheduled visits for safety and immune response assessments. The main outcome measured is the primary immune response 29 days after vaccination. Additional immune markers and safety data are also collected. Participants will be monitored closely to track any reactions or side effects, with all procedures conducted under medical supervision until the study ends in late 2025.

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