Federally Funded Healthcare Institution Primary Healthcare Unit No. 163
Novosibirsk, Russia
NCT Number: NCT05152017
The study the safety, reactogenicity and obtain preliminary data on the immunogenicity of Flu-M Quadro, 4-valent inactivated split influenza vaccine, in healthy volunteers
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Novosibirsk, Russia
The maximum period of the volunteers' participation in the trial will be 35 ± 2 days. Screening period - up to 7 days. The vaccine administration period is 1 day. Follow-up period - 28±2 days.
All volunteers are followed by a clinical investigator for 6 months after vaccination outside of this trial with the aim of detecting possible late adverse reactions. If a volunteer has any delayed-type reactions, the volunteer will be invited to the clinic for correction of his/her condition.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
solution for intramuscular injection, 0.5 ml
solution for intramuscular injection, 0.5 ml
solution for intramuscular injection, 0.5 ml
Time frame: days 1-7
Time frame: days 1-7
Time frame: days 1-28
Time frame: days 0, 28 after the vaccination
Time frame: days 0, 28 after the vaccination
Time frame: days 0, 28
It shout be more than 2.5 after the vaccination
Time frame: days 0, 28 after the vaccination
Time frame: days 0, 28 after the vaccination
St. Petersburg Research Institute of Vaccines and Sera
Other Gov
Phase I Simple Blind, Placebo Controlled, Randomized Safety and Reactogenicity Trial of the Flu-M Quadro Tetravalent Inactivated Split Influenza Vaccine, Solution for Intramuscular Injection, Produced by FSUE SPbSRIVS FMBA, vs. Placebo in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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