This phase III clinical trial was conducted to evaluate the immunogenicity and safety of the Tetravalent Influenza Vaccine I.P., containing two strains each of influenza A and B, developed indigenously in the country for the first time by M/s Cadila Healthcare Limited, India, for use in the pediatric population, and compare it to that of a licensed seasonal Trivalent Influenza Vaccine of Sanofi Pasteur India Private Limited, containing two influenzas A and one influenza B strains. Three hundred six subjects of either sex, six months to 17 years, were randomized in a 1:1 ratio to receive either TetIV or TriIV. Immunogenicity evaluations were performed using the hemagglutination inhibition assay at baseline and 28 days after the last vaccination. TetIV was found to fulfill the criteria set by the United States Food and Drug Administration on the requirements of clinical data for licensure of seasonal inactivated influenza vaccines for the pediatric population. The seroconversion rates with TetIV were 94.6% for A/H1N1, 93.9% for A/H3N2, 91.2% for B/Brisbane, and 87.2% B/Phuket strains. TetIV showed non-inferiority and superiority in immune response than TriIV against the shared strains and an additional B strain. Both the vaccines were tolerated, and the fourth strain in TetIV did not compromise the safety compared to that of TriIV. The most common adverse event reported in both groups was fever.
Reference: https://www.tandfonline.com/doi/full/10.1080/21645515.2020.1794683
