Assessment of Immunogenicity, Reactogenicity and Safety of the Drug GNG-DE in Comparison With the Reference Drug
Recruiting
Phase 3
Interventional Study
Infections
Meningococcal
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 3 – 55
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 240 (estimated)
- Sponsor
- NPO Petrovax · Industry
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About This Trial
Assessment of immunogenicity, reactogenicity and safety of GNG-DE in comparison with the reference drug
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male and female subjects aged 3-55 years old inclusive at the time of screening beginning.
2. Availability of a signed Volunteer Informed Consent Form (Volunteer Information Sheet, VIS) (for participants aged 7-55 years inclusive) and/or the parent/adoptive parent informed co…
Contacts