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

NCT ID: NCT01457027

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-08-31

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.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

All subjects

Group Type: EXPERIMENTAL

Inflexal V

Intervention Type: BIOLOGICAL

Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2011-2012 season, containing per 0.5 mL dose:

• 15 µg hemagglutinin (HA) antigen of A/California/7/2009 (H1N1)-like virus
• 15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus
• 15 µg HA antigen of B/Brisbane/60/2008-like virus

Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1

Interventions

Inflexal V

Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2011-2012 season, containing per 0.5 mL dose:

• 15 µg hemagglutinin (HA) antigen of A/California/7/2009 (H1N1)-like virus
• 15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus
• 15 µg HA antigen of B/Brisbane/60/2008-like virus

Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Crucell Holland BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giancarlo Icardi, MD

Role: PRINCIPAL_INVESTIGATOR

San Martino University Hospital

Locations

Dept. of Health Sciences, University of Genoa and Hygiene Unit, "San Martino" University Hospital

Genoa, , Italy

Countries

Italy

Other Identifiers

INF-V-A007

Identifier Type: -

Identifier Source: org_study_id