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NCT02362919 Clinical Trial

Influenza Vaccination Among the Elderly Individuals

Influenza Clinical Trial

Official title:
Determinants of Vaccine Response to Influenza Vaccination Among Individuals Over 65 Years of Age - a Population-based Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02362919
Other study ID # 1100359
Secondary ID
Status Completed
Phase N/A
First received February 9, 2015
Last updated September 8, 2017
Start date February 2015
Est. completion date May 2016

Study information
Verified date September 2017
Source Helmholtz Centre for Infection Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 200
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Helmholtz Centre for Infection Research Clinical Research Center, Hannover, Germany, Hannover Medical School, Hannover Unified Biobank, Hannover, Germany

Outcome
Type Measure Description Time frame Safety issue
Primary Serological evidence of vaccine response to influenza vaccination 4 months
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