Clinical trial NCT06800885: Repeated Cross Sectional Surveillance Study To Determine the Influenza Vaccination Rates in German Participants
Official title: Repeated Cross Sectional Surveillance Study To Determine the Influenza Vaccination Rates in German Participants During Current Respiratory Season
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Influenza Immunization
Keywords: Seasonal Influenza
Influenza Vaccination Rates
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-01-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years of age through and including 59 years of age
timeFrame: Throughout Study (Approximately 3 months)
measure: Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years through and including 34 years of age
timeFrame: Throughout Study (Approximately 3 months)
measure: Assessing the seasonal influenza vaccination rates among pregnant women (with or without co-morbidities)
timeFrame: Throughout Study (Approximately 3 months)
measure: Assessing the seasonal influenza vaccination rates among diverse patients with chronic illness
timeFrame: Throughout Study (Approximately 3 months)
measure: Assessing the seasonal influenza vaccination rates among diverse healthy participants 35 years through and including 59 years of age
timeFrame: Throughout Study (Approximately 3 months)
measure: Assessing the seasonal influenza vaccination rates among diverse healthy participants 18 years through and including 59 years of age
timeFrame: Throughout Study (Approximately 3 months)
measure: Assessing the seasonal influenza vaccination rates among diverse healthy participants older than 60 years of age
timeFrame: Throughout Study (Approximately 3 months)
measure: Assessing the seasonal influenza vaccination rates among diverse healthy participants aged 60 years of age through and including 69 years of age
timeFrame: Throughout Study (Approximately 3 months)
measure: Assessing the seasonal influenza vaccination rates among diverse healthy participants aged 70 years of age through and including 79 years of age
timeFrame: Throughout Study (Approximately 3 months)
measure: Assessing the seasonal influenza vaccination rates among diverse healthy participants older than 80 years of age
timeFrame: Throughout Study (Approximately 3 months)
Secondary outcomes:
measure: 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)
timeFrame: Throughout Study (approxmatley 3 months)
measure: 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)
timeFrame: Throughout Study (approxmatley 3 months)
measure: Assessing reasons for/against influenza vaccination in the target population of the STIKO recommendation for each season
timeFrame: Throughout study (approximatley 3 months)
measure: Assess the reliability of a demographic study based on randomly sampled population groups using Computer-Assisted Web Interview (CAWI) for estimating VCR
timeFrame: Throughout the study (approximatley 3 months)
measure: 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)
timeFrame: Throughout the study (approximatley 3 months)
Other outcomes:
Locations:
city: Germany
country: Germany
Study officials:
References: