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流感疫苗四价:安全性、有效性和免疫原性的临床经验。

Influvac Tetra: clinical experience on safety, efficacy, and immunogenicity.

机构信息

Global Medical Affairs, Viatris, Monza, Italy.

Global Medical Affairs, Viatris, Bengaluru, India.

出版信息

Expert Rev Vaccines. 2024 Jan-Dec;23(1):88-101. doi: 10.1080/14760584.2023.2293241. Epub 2023 Dec 15.

Abstract

INTRODUCTION

This paper summarizes the safety and immunogenicity data of Influvac Tetra across all age groups starting from 6 months of age, obtained during its clinical development program.

AREAS COVERED

The article covers the clinical development program of Influvac Tetra based on five registration studies that included different age groups, different comparators, and participants from Europe and Asia. Safety and immunogenicity were assessed in all studies and in one study, the efficacy of Influvac Tetra was assessed.

EXPERT OPINION

Seasonal influenza is a vaccine-preventable disease that can cause serious complications. Several types of influenza vaccines are available, including egg-based (standard dose, high dose, and adjuvanted), cell-based, and recombinant. The COVID-19 pandemic has stimulated innovation in the development such as mRNA vaccines. However, these vaccines are still in development and the true value still has to be proven. Regardless of the type of vaccine, it is also important to increase overall vaccination coverage. ECDC recommends that EU Member States implement action plans and policies aimed at reaching 75% coverage in at-risk groups and healthcare workers. Even so, vaccine coverage is still far from recommended.

摘要

简介

本文总结了从 6 个月龄开始的各个年龄段人群接种 Influvac Tetra 的安全性和免疫原性数据,这些数据来自其临床开发项目。

涵盖领域

本文基于涵盖不同年龄组、不同对照和来自欧洲和亚洲的参与者的五项注册研究,介绍了 Influvac Tetra 的临床开发项目。所有研究均评估了安全性和免疫原性,其中一项研究评估了 Influvac Tetra 的疗效。

专家意见

季节性流感是一种可通过疫苗预防的疾病,可导致严重并发症。有多种类型的流感疫苗可供选择,包括基于鸡蛋的(标准剂量、高剂量和佐剂)、基于细胞的和重组疫苗。COVID-19 大流行刺激了疫苗开发方面的创新,例如 mRNA 疫苗。然而,这些疫苗仍在开发中,其真正价值仍有待证明。无论疫苗类型如何,提高总体疫苗接种率也很重要。欧洲疾病预防控制中心建议欧盟成员国实施旨在使高危人群和医护人员的疫苗接种率达到 75%的行动计划和政策。即便如此,疫苗接种率仍远未达到建议水平。

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