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

Sponsor
NPO Petrovax
Study ID
NCT06834100
Phase
PHASE3
Status
Recruiting
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Conditions

  • Infections
  • Meningococcal

Eligibility Criteria

Sex
ALL
Age
3 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • polysaccharide conjugated vaccine for prevention of meningococcal infection of serogroups A, C, W, Y — DRUG
    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.

Study Details

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

Key Dates

First listed
Feb 19, 2025
Start date
Feb 12, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Stage I
    At this stage, adult volunteers aged 18-55 years old (inclusive) will be enrolled in the study. After screening procedures, 80 volunteers who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1: 1 ratio
  • Experimental: Stage II
    Stage II will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage I data. At this stage, adolescents aged 11-17 years old (inclusive) will be included in the study. After screening procedures, 80 adolescents who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratio
  • Experimental: Stage III
    Stage III will begin after receiving the positive conclusion of the IDMC on the basis of the consideration of stage II data. At this stage, children aged 3-10 years old (inclusive) will be included in the study. After screening procedures, 80 children who meet the eligibility criteria and do not meet any non-eligibility criteria will be randomized into 2 groups in a 1:1 ratiowill receive Menactra® at a dose of 0.5 mL intramuscularly into the deltoid site.

Primary Outcome Measure

Primary immunogenicity parameter [ Time Frame: Day 29 ± 1 ]

Central Contacts

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