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Clinical trial

Simple Blind, Placebo Controlled, Randomized, Two-stage, Prospective, Single-center Safety, Tolerability and Reactogenicity Trial of the [Recombinant Tuberculosis Allergen in Standard Dilution], Solution for Intradermal Injection, 0.1 mL/Dose, Produced by FSUE SPbSRIVS FMBA of Russia, in Healthy Volunteers After a Single Dose in the Dilution of 0.1 µg / 0.1 mL or 0.2 µg / 0.1 mL

NCT05398562 is registered in ClinicalTrials.gov with St. Petersburg Research Institute of Vaccines and Sera as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
Simple Blind, Placebo Controlled, Randomized, Two-stage, Prospective, Single-center Safety, Tolerability and Reactogenicity Trial of the [Recombinant Tuberculosis Allergen in Standard Dilution], Solution for Intradermal Injection, 0.1 mL/Dose, Produced by FSUE SPbSRIVS FMBA of Russia, in Healthy Volunteers After a Single Dose in the Dilution of 0.1 µg / 0.1 mL or 0.2 µg / 0.1 mL
Lead sponsor
St. Petersburg Research Institute of Vaccines and Sera
Phase
Phase 1
Overall status
Completed
Start date
February 13, 2020
Completion date
June 26, 2020
Enrollment
75 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

skin tests, tuberculosis