Clinical trial NCT01457027: A Study to Assess Immunogenicity Parameters After Vaccination Against Influenza and to Evaluate How These Parameters Change During the Influenza Season
Official title: A Phase IV, Open Label Study to Evaluate the Short and Long Term Immune Response and CROSS-protection After Vaccination With viroSOME Adjuvanted Inflexal V in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Virus
Vaccination
Immunisation
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2011-10-21
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Seroprotection
timeFrame: 3 weeks after vaccination (Day 22 ± 2 days)
measure: Seroconversion
timeFrame: 3 weeks after vaccination (Day 22 ± 2 days)
measure: Geometric Mean Titer
timeFrame: 3 weeks after vaccination (Day 22 ± 2 days)
Secondary outcomes:
measure: Geometric Mean Titer
timeFrame: 6 months post-vaccination
measure: Seroprotection
timeFrame: 6 months post-vaccination
measure: Seroconversion
timeFrame: 6 months post-vaccination
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: Dept. of Health Sciences, University of Genoa and Hygiene Unit, "San Martino" University Hospital
Study officials:
affiliation: San Martino University Hospital
name: Giancarlo Icardi, MD
role: PRINCIPAL_INVESTIGATOR
References: