Clinical trial NCT02362919: Influenza Vaccination Among the Elderly Individuals
Official title: Determinants of Vaccine Response to Influenza Vaccination Among Individuals Over 65 Years of Age - a Population-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Influenza vaccination
Elderly individuals
Prospective cohort study
response
Lead sponsor: Helmholtz Centre for Infection Research
Sponsor class: OTHER
Collaborators: name: Clinical Research Center, Hannover, Germany
name: Hannover Unified Biobank, Hannover, Germany
name: Hannover Medical School
First posted: 2015-02-13
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females aged 65 and 80 years from the general population

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serological evidence of vaccine response to influenza vaccination
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Twincore Centre for Experimental and Clinical Infection Research, Hannover, Germany
name: Frank Pessler, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akmatov MK, Riese P, Trittel S, May M, Prokein J, Illig T, Schindler C, Guzman CA, Pessler F. Self-reported diabetes and herpes zoster are associated with a weak humoral response to the seasonal influenza A H1N1 vaccine antigen among the elderly. BMC Infect Dis. 2019 Jul 23;19(1):656. doi: 10.1186/s12879-019-4214-x.
citation: Akmatov MK, Jentsch L, Riese P, May M, Ahmed MW, Werner D, Rosel A, Prokein J, Bernemann I, Klopp N, Prochnow B, Illig T, Schindler C, Guzman CA, Pessler F. Motivations for (non)participation in population-based health studies among the elderly - comparison of participants and nonparticipants of a prospective study on influenza vaccination. BMC Med Res Methodol. 2017 Feb 2;17(1):18. doi: 10.1186/s12874-017-0302-z.