1. Immunogenicity and safety of live attenuated influenza vaccine in children aged 3-17 years in China.
- Author
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Ai L, Gao Z, Lv H, Zhang J, Xu N, Zhao H, Lu Q, Zhu H, Shi N, Wei W, Liu D, and Yu Q
- Subjects
- Humans, Adolescent, Child, Child, Preschool, Double-Blind Method, Male, China, Female, Influenza Vaccines immunology, Influenza Vaccines adverse effects, Influenza Vaccines administration & dosage, Vaccines, Attenuated immunology, Vaccines, Attenuated adverse effects, Vaccines, Attenuated administration & dosage, Antibodies, Viral blood, Influenza, Human prevention & control, Influenza, Human immunology, Hemagglutination Inhibition Tests, Immunogenicity, Vaccine
- Abstract
(1) Background: The administration of a live attenuated influenza vaccine (LAIV) has emerged as a viable option for preventing pediatric infections. The LAIV vaccine is available in China based on efficacy results. However, LAIV immunogenicity in children aged 3-17 years old in China has not yet to be studied and reported broadly. (2) Methods: This is a substudy investigating the immunogenicity and safety of the LAIV under a Phase 3, multicentre, randomized, double-blind, placebo-controlled trial. A total of 3000 participants were enrolled in a randomized, double-blind, placebo-controlled trial, split in half between vaccine and placebo, was conducted to evaluate a single LAIV dose in this age group. Hemagglutination inhibition (HI) antibody titers and incidence of adverse events were used to evaluate immunogenicity and safety, respectively. (3) Results: Although there was no significant difference in frequencies of all solicited or unsolicited AEs, nasal congestion, headache, and muscle pain were statistically significantly more frequent in vaccine recipients as compared to placebo Seroconversions and geometric mean fold increases in HI antibody titers against all strains were significantly higher in the vaccine group than in the placebo group. (4) Conclusions: The LAIV is safe and immunogenic in Chinese children and adolescents., Competing Interests: Declaration of competing interest This manuscript has not been published or presented elsewhere in part or in entirety and is not under consideration by another journal. All study participants provided informed consent, and the study design was approved by the appropriate ethics review board. We have read and understood your journal's policies, and we believe that neither the manuscript nor the study violates any of these. There are no conflicts of interest to declare., (Copyright © 2024 Elsevier Ltd. All rights reserved.)
- Published
- 2025
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