Influenza Vaccination Among the Elderly Individuals

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02362919

Enrollment

200

Registered

2015-02-13

Start date

2015-02-28

Completion date

2016-05-31

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza vaccination, Elderly individuals, Prospective cohort study, response

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Serological evidence of vaccine response to influenza vaccination	4 months

Outcome results