# Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years

> **NCT05312294** · PHASE3 · COMPLETED · sponsor: **St. Petersburg Research Institute of Vaccines and Sera** · enrollment: 654 (actual)

## Conditions studied

- Influenza
- Flu, Human

## Interventions

- **BIOLOGICAL:** Flu-M [inactivated split influenza vaccine] without preservative
- **BIOLOGICAL:** Flu-M [inactivated split influenza vaccine] with preservative

## Key facts

- **NCT ID:** NCT05312294
- **Lead sponsor:** St. Petersburg Research Institute of Vaccines and Sera
- **Sponsor class:** OTHER_GOV
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-12-07
- **Primary completion:** 2021-09-03
- **Final completion:** 2021-11-15
- **Target enrollment:** 654 (ACTUAL)
- **Last updated:** 2022-04-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05312294

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05312294, "Tolerability, Safety and Immunogenicity Trial of the Flu-M® Inactivated Vaccine in Volunteers Aged 18 to 60 Years". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT05312294. Licensed CC0.

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