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Influenza Vaccination Among the Elderly Individuals

Completed
Conditions
Influenza
Registration Number
NCT02362919
Lead Sponsor
Helmholtz Centre for Infection Research
Brief Summary

The aims of the study are to a) identify individuals with a poor response to influenza vaccination and b) identify factors associated with a poor response to influenza vaccination.

Detailed Description

This is a population-based prospective cohort study. Potential participants, males and females between 65 and 80 years of age, were selected randomly through the resident registration office in Hannover city, Germany and invited with a personalized letter to participate in the study.

Initially, a blood sample (40 ml) will be drawn from each participant (day 0). Furthermore, participants will be vaccinated against influenza with FLUAD 2014/2015. FLUAD is a trivalent, surface antigen, inactivated influenza virus vaccine adjuvanted with MF59C.1. Additional five blood samples will be collected during the study period of four months (at days 3, 7, 21, 70 and 130). Information about current and past infections, chronic diseases and basic sociodemographic data will be collected through a self-administered questionnaire.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
Inclusion Criteria
  • Individuals between 65 and 80 years of age
Exclusion Criteria
  • Individuals with a known hypersensitivity to any of the excipients and to eggs, chicken Protein, kanamycin and neomycin sulphate, formaldehyde, and cetyltrimethylammonium bromide
  • Individuals, who have an acute infection during the visit at the study Center
  • Individuals with cognitive impairment
  • Individuals already vaccinated with influenza vaccination in the influenza season 2014/15

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Serological evidence of vaccine response to influenza vaccination4 months
Secondary Outcome Measures
NameTimeMethod
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