Influenza Vaccination Among the Elderly Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A cohort of elderly individuals

A cohort of elderly individuals between 65 and 80 years of age were vaccinated with Fluad, a seasonal inactivated trivalent adjuvanted influenza vaccine. Blood samples before (day 0) and at days 1/3, 7,21 and 70 after vaccination were collected.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes