A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus (NCT06385821) | Clinical Trial Compass
CompletedPhase 3
A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus
Russia824 participantsStarted 2022-09-21
Plain-language summary
The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination".
Who can participate
Age range6 Months – 5 Years
SexALL
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Inclusion criteria
✓. Male and female children aged 6 months to 5 years inclusive at the time of vaccination.
✓. Availability of Informed consent to participate in the study, signed by one of the parents.
✓. The diagnosis is "healthy", established according to standard clinical, laboratory and instrumental methods of examination carried out at screening, according to the assessment of the researcher, as well as anamnesis data (absence of acute and chronic diseases of the respiratory, cardiovascular, nervous systems, dysfunction liver or kidneys).
✓. Negative result of a rapid test for SARS-CoV-2 antigen at screening.
✓. For children aged 6 to 11 months inclusive: children born at gestational age ≥37 weeks weighing ≥2.5 kg.
✓. Parental consent to cooperate in good faith with the investigator and center staff, attend scheduled visits, complete the self-monitoring diary, and follow the protocol.
Exclusion criteria
✕. Vaccination with any influenza vaccine within the previous 6 months. Vaccination with other vaccines, according to the national vaccination schedule, is allowed no later than 30 days before the introduction of the study vaccine, and no earlier than 30 days after the administration of the study vaccines.
✕. Participation in a clinical trial of a vaccine, medicinal product, or medical device less than 30 days prior to screening.
✕. Hypersensitivity to any of the components of the studied vaccines or severe post-vaccination complications to any vaccine in history.
What they're measuring
1
To prove non-inferior immunogenicity of the Grippol Quadrivalent vaccine when compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three matching strains of the compared vaccines
. The presence at the time of screening of acute infectious diseases of any localization, or the presence of a history of acute infectious and non-infectious diseases less than 14 days before screening.
✕. Body temperature in the armpit ≥37.0°C at screening or before the introduction of the vaccine.
✕. History of significant chronic diseases, such as malignant neoplasms or blood diseases, autoimmune diseases, insulin-dependent diabetes mellitus, chronic diseases of the lungs, liver or kidneys, cardiovascular, nervous systems, secondary, primary and induced immunodeficiency, HIV- infections, as well as other significant, according to the researcher, diseases.
✕. A history of seizures or a progressive neurological disease.