A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere

Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2008/2009-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations

A study to assess whether the Northern Hemisphere 2008/2009 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Allschwil, Switzerland, 4123
    • Covance Clinical Research Unit AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Healthy female and male adults
• Aged ≥18 to ≤60 years or >60 years on Day 1
• Written informed consent

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 in the past 330 days
• 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 study vaccine; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
• Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
• 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)
• Pregnancy or lactation
• Participation in another clinical trial
• Employee at the investigational site, or relative or spouse of the investigator
• Suspected non-compliance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Adults from 18 to 60 years old inclusive	Biological: Inflexal V; Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2008-2009 season, containing per 0.5 mL dose: 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus; 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus; 15 µg HA antigen of B/Florida/4/2006-like virus Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1
Experimental: Group B; Elderly subjects aged over 60 years	Biological: Inflexal V; Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2008-2009 season, containing per 0.5 mL dose: 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus; 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus; 15 µg HA antigen of B/Florida/4/2006-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
Fold Increase in Geometric Mean Titer (GMT)	GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value	Day 22/Day 1
Seroconversion	Seroconversion rate was defined as the proportion of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40	Day 22 ± 2 days
Seroprotection	Seroprotection rate, defined as the proportion of subjects with HI antibody titer ≥1:40	Day 22 ± 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Incidence of Solicited Local Adverse Events	Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination	Days 1 to 4 inclusive, and Day 22
Incidence of Solicited Systemic Adverse Events	Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination	Days 1 to 4 inclusive, and Day 22

Collaborators and Investigators

• Sponsor: Crucell Holland BV
• Investigators: Principal Investigator: Michael Seiberling, MD, Covance Clinical Research Unit AG

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): September 9, 2013
• Last Update Submitted That Met QC Criteria: August 29, 2013
• Last Verified: August 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-A002