Repeated Cross Sectional Surveillance Study To Determine the Influenza Vaccination Rates in German Participants

NCT06800885 | Completed

• 1 other identifier: FLU00216
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Influenza Immunization

Keywords

Seasonal Influenza; Influenza Vaccination Rates

Outcome Measures

Primary Outcomes (10)

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

  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

  Throughout Study (Approximately 3 months)

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

  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

  Throughout Study (Approximately 3 months)

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

  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

  Throughout Study (Approximately 3 months)

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

  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

  Throughout Study (Approximately 3 months)

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

  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

  Throughout Study (Approximately 3 months)

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

  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

  Throughout Study (Approximately 3 months)

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

  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

  Throughout Study (Approximately 3 months)

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

  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

  Throughout Study (Approximately 3 months)

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

  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

  Throughout Study (Approximately 3 months)

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

  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

  Throughout Study (Approximately 3 months)

Secondary Outcomes (5)

• 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)

Study Arms (4)

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

Subgroup 2: Patients with Chronic Illness

Diverse patients with chronic illness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The number of participants surveyed will be approximately 6,000 per season using CAWI. These are spread over a total of 6 waves per season, resulting in a sample size of 1,000 respondents per wave using CAWI. The study will target a disproportionate sample of the German population regarding age: 30% aged 18 years of age though and including 59 years of age and 70% aged 60 years of age 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Germany, Germany

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: October 22, 2024
• Primary Completion: February 22, 2026
• Study Completion: February 22, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)