A Study to Assess Immunogenicity Parameters After Vaccination Against Influenza and to Evaluate How These Parameters Change During the Influenza Season

Crucell

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: Inflexal V

Study type

Interventional

Funder types

Industry

Identifiers

NCT01457027

INF-V-A007

Details and patient eligibility

About

A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evaluate immunogenicity parameters 6 months after vaccination for the 3 vaccine strains and to assess the cross-protection against 4 selected circulating heterogeneous A/H1N1 influenza strains 3 weeks after influenza vaccination versus baseline.

Enrollment

52 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy female and male adults aged >60 years on the day of enrollment
Written informed consent
Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause)

Exclusion criteria

Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
Acute febrile illness (≥38.0 °C)
Prior vaccination with an influenza vaccine for season 2011/2012
Known hypersensitivity to any vaccine component
Previous history of a serious adverse reaction to influenza vaccine
History of egg protein allergy or severe atopy
Known blood coagulation disorder
Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/day prednisolone or equivalent (inhaled or topical steroids are allowed)
Known immunodeficiency (including leukemia, HIV seropositivity) or cancer
Investigational medicinal product received in the past 3 months (90 days)
Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
Participation in another clinical trial
Employee at the investigational site or relative of the investigator
Anticipated non-compliance with study procedures