Influenza vaccination in old age: Factors contributing to a good immune response

Conditions: This study will analyze cellular and humoral immune responses after seasonal vaccination against influenza. Healthy adults are vaccinated with a licensed trivalent inactivated vaccine without adjuvant. The vaccine is licensed for all age groups studied in this study.
MedDRA version: 14.0Level: LLTClassification code 10016794Term: Flu vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 14.0Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2011-002147-10-AT

Lead Sponsor: Institute for Biomedical Aging Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

signed informed consent form
participant of the former MARK-AGE study
no previous influenza vaccination in the 2011/2012 season

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

acute illness
chronic inflammatory disease (e.g. inflammatory bowl disease, Multiple Sclerosis)
chronic infection with HBV, HCV or HIV
transplant recipients
persons who have recieved chemotherapy in the past
persons under immunosuppressive therapy
pregnant women
participation in another clinical trial during the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To analyze the humoral and cellular immune response after influenza vaccination in different age groups (>35 years). Determination of influence of age on vaccine-induced immune response and analysis of interaction between cellular and humoral responses.;Secondary Objective: Identification of biological parameters for prediction of vaccination success. Immunological and biogerontological characterisation of responders and non-responders.;Primary end point(s): Quantification of vaccine-induced immune responses 4 weeks after vaccination

Secondary Outcome Measures