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Trial record 1 of 1 for:    1100359
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Influenza Vaccination Among the Elderly Individuals

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ClinicalTrials.gov Identifier: NCT02362919
Recruitment Status : Completed
First Posted : February 13, 2015
Last Update Posted : September 11, 2017
Sponsor:
Collaborators:
Clinical Research Center, Hannover, Germany
Hannover Unified Biobank, Hannover, Germany
Hannover Medical School
Information provided by (Responsible Party):
Helmholtz Centre for Infection Research

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.

Condition or disease
Influenza

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Vaccine Response to Influenza Vaccination Among Individuals Over 65 Years of Age - a Population-based Study
Actual Study Start Date : February 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort
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.



Primary Outcome Measures :
  1. Serological evidence of vaccine response to influenza vaccination [ Time Frame: 4 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Males and females aged 65 and 80 years from the general population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362919


Sponsors and Collaborators
Helmholtz Centre for Infection Research
Clinical Research Center, Hannover, Germany
Hannover Unified Biobank, Hannover, Germany
Hannover Medical School
Investigators
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Principal Investigator: Frank Pessler, PD Dr. Twincore Centre for Experimental and Clinical Infection Research, Hannover, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helmholtz Centre for Infection Research
ClinicalTrials.gov Identifier: NCT02362919    
Other Study ID Numbers: 1100359
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Keywords provided by Helmholtz Centre for Infection Research:
Influenza vaccination
Elderly individuals
Prospective cohort study
response
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases