Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains (2013-14)

Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2013/2014-season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations

The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Arzo, Switzerland, 6864
    • CROSS Research S.A. - Phase I Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy female and male adults aged ≥18 on Day 1
• Written informed consent
• Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

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 the study vaccine, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
• Known immunodeficiency (incl. leukemia, HIV seropositivity), 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)
• Pregnancy or lactation
• Participation in another clinical trial
• Employee at the investigational site, or relative of the investigator
• Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Elderly subjects aged over 60 years	Biological: Inflexal V; Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V; Other Names: Inflexal V influenza vaccine (surface antigen, inactivated, virosome) formulated for the WHO requirements of the 2013-2014 season, each 0.5 mL dose containing:; • 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus; • 15 µg HA antigen of A/Texas/50/2012 (H3N2)-like virus; • 15 µg HA antigen of B/Massachusetts/2/2012-like virus
EXPERIMENTAL: Adults from 18 to 60 years old inclusive	Biological: Inflexal V; Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V; Other Names: Inflexal V influenza vaccine (surface antigen, inactivated, virosome) formulated for the WHO requirements of the 2013-2014 season, each 0.5 mL dose containing:; • 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus; • 15 µg HA antigen of A/Texas/50/2012 (H3N2)-like virus; • 15 µg HA antigen of B/Massachusetts/2/2012-like virus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT)	Immunogenicity variables are analyzed according to the EMA re-licensing criteria; at least one of the criteria has to be fulfilled for each vaccine strain: Seroconversion rate at Day 22 has to be >40% of subjects aged ≥18 to ≤60 years and >30% of subjects aged >60 years, or; Seroprotection rate at Day 22 has to be >70% of subjects aged ≥18 to ≤60 years and >60% of subjects aged >60 years, or; GMT-fold increase at Day 22 compared to baseline: a >2.5-fold increase has to be reached in subjects aged ≥18 to ≤60 years and a >2.0-fold increase has to be reached in subjects aged >60 years	Day 22 +/- 2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of solicited local adverse events	Days 1 to 4 inclusive
Incidence of solicited systemic adverse events	Days 1 to 4 inclusive
Incidence of unsolicited adverse events	Days 1 to 22 inclusive

Collaborators and Investigators

• Sponsor: Crucell Holland BV

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (ESTIMATE): July 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 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; Virus; Inflexal V
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: INF-V-A018