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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Inflexal V

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Genoa, Italy, 16100
    • Dept. of Health Sciences, University of Genoa and Hygiene Unit, "San Martino" University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All subjects

Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprotection	Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)	3 weeks after vaccination (Day 22 ± 2 days)
Seroconversion	Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)	3 weeks after vaccination (Day 22 ± 2 days)
Geometric Mean Titer	GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)	3 weeks after vaccination (Day 22 ± 2 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titer	GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)	6 months post-vaccination
Seroprotection	Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)	6 months post-vaccination
Seroconversion	Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters will be analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)	6 months post-vaccination

Collaborators and Investigators

• Sponsor: Crucell Holland BV
• Investigators: Principal Investigator: Giancarlo Icardi, MD, San Martino University Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 20, 2011
• First Submitted That Met QC Criteria: October 20, 2011
• First Posted (Estimate): October 21, 2011

Study Record Updates

• Last Update Posted (Estimate): February 20, 2013
• Last Update Submitted That Met QC Criteria: February 19, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Influenza; Vaccination; Immunisation; Virus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: INF-V-A007