Influenza Vaccination Among the Elderly Individuals

NCT02362919 | Completed

• 1 other identifier: 1100359
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza

Keywords

Influenza vaccination; Elderly individuals; Prospective cohort study; response

Outcome Measures

Primary Outcomes (1)

• Serological evidence of vaccine response to influenza vaccination

  4 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Males and females aged 65 and 80 years from the general population

You may qualify if:

• Individuals between 65 and 80 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Helmholtz Centre for Infection Research: lead
• Clinical Research Center, Hannover, Germany: collaborator
• Hannover Unified Biobank, Hannover, Germany: collaborator
• Hannover Medical School: collaborator

Related Publications (2)

• 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.

  PMID: 31337344 DERIVED

• 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.

  PMID: 28148221 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Frank Pessler, PD Dr.

  Twincore Centre for Experimental and Clinical Infection Research, Hannover, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 13, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 11, 2017

Record last verified: 2017-09