Influenza Vaccination Among the Elderly Individuals

Helmholtz Centre for Infection Research

Status: Completed

Conditions: Influenza

Study type: Observational

Funder types: Other

Identifiers

NCT02362919

1100359

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 1 patient group

A cohort of elderly individuals

Description:

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.