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临床试验/NCT06800885
NCT06800885已完成不适用

Repeated Cross Sectional Surveillance Study To Determine the Influenza Vaccination Rates in German Participants During Current Respiratory Season

Sanofi Pasteur, a Sanofi Company1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2024年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5,000
试验地点
1
主要终点
Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years of age through and including 59 years of age

研究概览

简要总结

Real-time monitoring of vaccination rates for Germany is unavailable, and up-to-date data publication is delayed, which makes it challenging to develop effective public health strategies to increase vaccination coverage.

This study aims to address the gap by assessing current influenza vaccination rates, particularly among those aged 60 and older, to inform public health interventions and encourage healthcare providers to recommend influenza vaccination more proactively.

The primary objective of this study is to determine the influenza vaccination rates in the German population during the current respiratory season. The study will focus on:

  1. Assessing the vaccination rates among the two main age groups 18 years of age through and including 59 years of age and 60 years of age (inclusive) and older
  2. Assessing the vaccination rate among individuals with risk-based vaccination recommendation according to Standing Committee on Vaccination (Ständige Impfkommission) (STIKO) The study will target a disproportionate sample of the German population regarding age: 30% aged 18 years of age through and including 59 year of age and 70% aged 60 years of age (inclusive) and older. Within these age groups, the study targets a representative distribution regarding gender and region.

This study is conducted as an online survey that will either be self-completed by the respondents (CAWI) or completed via an interviewer for a subgroup of respondents aged 70+ (CATI). The survey is estimated to last 10 minutes and will comprise of closed-ended questions only (i.e., respondents will not have the possibility to add any free-text). The survey will be conducted in German.

The panelists will be divided into strata based on demographic variables like gender and region. Within each stratum, participants will be randomly selected to participate in the survey.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Reside in Germany at the time of survey completion
  • •Be at least 18 years old at the time of survey completion.
  • •Agree with privacy policy and AE (Adverse Event) reporting requirements before proceeding with the survey.
  • •Read and agree to the ICF (Informed Consent Form) by ticking a box before proceeding with the survey or telephone interview.

排除标准

  • •Participation in the study (= completed the survey or telephone interview) in a previous wave of the current season.
  • •Living in nursing home Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

研究组 & 干预措施

Subgroup 2: Patients with Chronic Illness

Diverse patients with chronic illness

Group 1: 18 Years of Age to 59 Years of age

Healthy diverse adults aged 18 years to 59 (inclusive) years of age

Group 2: 60 Years of Age and Older

Healthy diverse adults aged 60 years (inclusive) of age and older

Subgroup 1: Pregnant Women 18 Years of Age to 59 Years of Age

Pregnant woman aged 18 years to 59 (inclusive) years of age

结局指标

主要结局

Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years of age through and including 59 years of age

时间窗: Throughout Study (Approximately 3 months)

Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 18 years of age to and including 59 years of age

Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years through and including 34 years of age

时间窗: Throughout Study (Approximately 3 months)

Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 18 years of age through 34 years of age

Assessing the seasonal influenza vaccination rates among pregnant women (with or without co-morbidities)

时间窗: Throughout Study (Approximately 3 months)

Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in pregnant women with or without co-morbidities

Assessing the seasonal influenza vaccination rates among diverse patients with chronic illness

时间窗: Throughout Study (Approximately 3 months)

Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in diverse patients with chronic illness

Assessing the seasonal influenza vaccination rates among diverse healthy participants 35 years through and including 59 years of age

时间窗: Throughout Study (Approximately 3 months)

Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 35 years of age through and including 59 years of age

Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years through and including 59 years of age

时间窗: Throughout Study (Approximately 3 months)

Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 18 years of age through and including 59 years of age

Assessing the seasonal influenza vaccination rates among diverse healthy participants older than 60 years of age

时间窗: Throughout Study (Approximately 3 months)

Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the older than 60 years of age group

Assessing the seasonal influenza vaccination rates among diverse healthy participants aged 60 years of age through and including 69 years of age

时间窗: Throughout Study (Approximately 3 months)

Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 60 years of age through and including 69 years of age

Assessing the seasonal influenza vaccination rates among diverse healthy participants aged 70 years of age through and including 79 years of age

时间窗: Throughout Study (Approximately 3 months)

Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the age group 70 years of age through and including 79 years of age

Assessing the seasonal influenza vaccination rates among diverse healthy participants older than 80 years of age

时间窗: Throughout Study (Approximately 3 months)

Descriptive analysis of vaccination status (yes/no) will be performed using summary statistics, i.e., proportion of vaccinated individuals among all enrolled persons per wave in the older than 80 years of age group

次要结局

  • Assessing the seasonal evolution of the influenza vaccination coverage rates (VCR) among the two main age groups 18 years of age through and including 59 years of age and 60 years of age and older (inclusive)(Throughout Study (approxmatley 3 months))
  • Assessing the seasonal evolution of the influenza vaccination coverage rates (VCR) through time trends among the two main age groups 18 years of age through and including 59 years of age and 60 years of age and older (inclusive)(Throughout Study (approxmatley 3 months))
  • Assessing reasons for/against influenza vaccination in the target population of the STIKO recommendation for each season(Throughout study (approximatley 3 months))
  • Assess the reliability of a demographic study based on randomly sampled population groups using Computer-Assisted Web Interview (CAWI) for estimating VCR(Throughout the study (approximatley 3 months))
  • Compare the reliability of VCR estimates in the elderly population (70+ years) obtained through a mixed approach of CAWI and Computer assisted telephone interview (CATI) versus CAWI only (in the first season)(Throughout the study (approximatley 3 months))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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