Immunogenicity and safety of the first indigenously developed Indian tetravalent influenza vaccine (split virion) in healthy children (6 months to 17 years of age): a randomized, multicenter, phase III clinical trial
| Autor: | Ravindra Mittal, CM Bokade, Sumantra Sarkar, Ravi Kumar, Jayesh Sanmukhani, Kapil Garg |
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| Rok vydání: | 2020 |
| Předmět: |
Trivalent influenza vaccine
vaxigrip vaxi-flu 4 Influenza vaccine 030231 tropical medicine Immunology India immunogenicity Antibodies Viral 03 medical and health sciences Immunogenicity Vaccine Influenza A Virus H1N1 Subtype 0302 clinical medicine children Influenza Human Humans Immunology and Allergy Medicine Vaccines Combined 030212 general & internal medicine Child sanofi Pasteur Pharmacology business.industry Influenza A Virus H3N2 Subtype Immunogenicity Virion cadila Healthcare Limited virus diseases Influenza a Hemagglutination Inhibition Tests Virology Tetravalent influenza vaccine Clinical trial Vaccines Inactivated Influenza Vaccines trivalent influenza vaccine business Research Article Research Paper |
| Zdroj: | Human Vaccines & Immunotherapeutics article-version (VoR) Version of Record |
| ISSN: | 2164-554X 2164-5515 |
| Popis: | This phase III clinical trial was conducted to evaluate the immunogenicity and safety of the Tetravalent Influenza Vaccine (Split virion) I.P. (TetIV), 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 (6 months −17 years of age), and compare it to that of a licensed seasonal Trivalent Influenza Vaccine (TriIV) of Sanofi Pasteur India Private Limited, containing two influenza A and one influenza B strains. Three hundred six subjects of either sex, 6 months to 17 years of age, were randomized in a 1:1 ratio to receive either TetIV or TriIV. Immunogenicity assessments (antibodies against A/H1N1, A/H3N2, B/Phuket, and B/Brisbane) 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% for B/Phuket strains. TetIV showed non-inferiority and superiority in immune response, as compared to TriIV, against the shared strains and an additional B strain, respectively. Both the vaccines were tolerated well by all the study participants, and an addition of the fourth strain in TetIV did not compromise the safety as compared to that of TriIV. The most common adverse event reported in both groups was fever. |
| Databáze: | OpenAIRE |
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