Evaluation of RSV/Flu-01E Vaccine for the Prevention of RSV Infection in Volunteers Aged 18 to 59… (NCT05970744) | Clinical Trial Compass
CompletedPhase 1
Evaluation of RSV/Flu-01E Vaccine for the Prevention of RSV Infection in Volunteers Aged 18 to 59 Years and Over 60 Years
Russia60 participantsStarted 2023-05-10
Plain-language summary
The aim of the study is to investigate the safety and immunogenicity of the RSV/Flu-01E vaccine for the prevention of respiratory syncytial virus infection in volunteers aged18 to 59 years and over 60 years.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Availability of signed informed consent.
✓. Adult men and women aged 18-59 years.
✓. Diagnosed "healthy", according to the data of standard clinical, laboratory and instrumental examination methods provided for in this protocol, with the absence of clinically significant changes.
✓. BMI from 18 to 30 kg/m2.
✓. Individuals with antibody titer to influenza A/H1N1pdm09 ≤1:20 according to HI assay.
✓. Ability and willingness to independently keep records in the diary of self-observation and carry out all visits according to the protocol.
✓. Negative urine test for psychotropic and narcotic substances.
✓. Negative breath alcohol test.
Exclusion criteria
✕. Participation in another clinical study within three months prior to the start of the current study; planning to participate in another study during the current study period.
✕. Contact with COVID-19 patients within 14 days prior to the start of the clinical study.
✕. Positive rapid test result for SARS-CoV-2 antigen.
✕. Immunization with any other non-study vaccine product within three weeks prior to enrollment in the current study, or refusal to postpone such until the end of the three-week period after completion of the current study.
What they're measuring
1
Number of participants with local and systemic adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Throughout the study, average of 6 months
✕. Regular use of nasal irrigation therapy during the last six months prior to enrollment in the current study or episodic use of the above method of treatment in the two weeks prior to the screening.
✕. History of frequent nosebleeds (\>5) during the year prior to the current study
✕. Anatomical features of the nose that may interfere with intranasal administration of the study drug
✕. The presence of surgical intervention in the sinus area, paranasal sinuses, or traumatic injuries of the nose within a month before screening.