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High-dose influenza vaccines deliver equal safety and robust protection for children under three with age-appropriate dosing.
A recent Phase III study conducted across numerous centres in India has revealed that a renowned tetravalent inactivated influenza vaccine was as safe and effective as the widely used vaccine in 6 to 35-month-old children. Influenza is a leading cause of acute respiratory infections in young children, particularly in those under two, with an estimated 5-10% of cases in India. Kairav Kothari et al. aimed to compare the immunogenicity and safety of tetravalent inactivated influenza vaccines.
Conducted between May and October 2022, the trial involved 346 healthy children who received two doses of either vaccine. As per the guidance from the Advisory Committee on Immunization Practices, the suggested dose for children aged 6 to 35 months was raised from 0.25 mL to 0.5 mL to boost the immune response.
The results showed that both vaccines induced a robust immune response, with seroprotection rates exceeding 95%, seroconversion rates above 90%, and substantial increases in geometric mean titers for all four vaccine strains. Safety profiles were comparable for both vaccines, with common adverse events (mild pain at the site of the injection, skin redness, swelling and fever).
Human Vaccines & Immunotherapeutics
A prospective, randomized, parallel, active controlled, phase III Indian study of immunogenicity and safety of two inactivated influenza vaccines - Vaxiflu-4 and Fluarix tetra in children aged 6 months to 35 months
Kairav Kothari et al.
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