Status and phase
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Treatments
About
Comparative trial of tolerability, reactogenicity, safety and immunogenicity of the Flu-M vaccine as compared to the Vaxigrip® vaccine in terms of prevention of influenza in children aged 6 months to 9 years (at the time of the first vaccination).
Full description
The trial includes 2 stages (stage I, II). At stage I children aged 3-9 years will be included. Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Vaxigrip® vaccine for the first 7 days after vaccination of volunteers during Stage I, an intermediate report will be prepared. The report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage II of the trial - the continuation of trial on children aged 3-9 years and the commencement of trial on children aged between 6 months and 35 months. During Stage II, the trial for Stage I volunteers will continue in full and also children aged between 6 and 35 months will be included in the trial.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
For volunteers aged 3 to 9 years:
For volunteers aged 6 to 35 months:
For all volunteers:
Ability of a volunteer's parents to fulfill the requirements of the Protocol (i.e. to fill out the Patient Diary, come to visit with the volunteer).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,066 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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