Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine

A Phase I, Open Label, Randomized Study in Healthy Adults to Compare Safety and Immunogenicity of Different Administration Schedules of Virosomal Influenza Vaccine

The goal of the study is to assess the safety and immune response after vaccination with different doses and vaccination schedules of virosomal influenza vaccine.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Virosomal influenza vaccine

Detailed Description

Virosomal influenza vaccine is usually administered intramuscularly as a single 0.5 mL dose. The aim of this study is to evaluate the safety and immunogenicity of different doses and vaccination schedules. A total of 84 healthy adults aged 18-50 years will be randomized (1:1:1) into 3 treatment groups: subjects of group 1 will receive a standard dose (0.5 mL) at Days 1, 29, and 57; subjects of group 2 will receive a double dose (1.0 mL) at Day 1 and a standard dose (0.5 mL) at Day 57; subjects of group 3 will receive a triple dose (0.5 mL) at Day 1. Local and systemic solicited adverse events up to Day 4 after each vaccination will be documented. To assess the subjects' humoral and cellular immune response against homologous and heterologous virus strains, blood will be drawn from each participant at baseline (Day 1), at the 4 subsequent monthly visits (Months 1 to 4) and at Month 12.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2610
    • Center for the Evaluation of Vaccination, Unit of Epidemiology and Social Medicine, University of Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female adults
• Aged ≥ 18 to ≤ 50 years on the day of enrollment
• 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
• Body weight below 40 kg at any visit during the study
• Acute febrile illness (≥ 38.0°C)
• Known hypersensitivity to any vaccine component
• Previous history of a serious adverse reaction to influenza vaccine
• Previous vaccination with a seasonal influenza vaccine for season 2011-2012 or a virosomal formulation of seasonal influenza vaccine in any season
• 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) or cancer
• Known history of psychiatric diseases, particularly dementia
• 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 for the entire duration of this trial
• Employee at the investigational site or relative of the investigator
• Subjects who in the view of investigator will not comply with study procedure and/or visit requirements as per protocol

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 1 x standard dose (0.5 mL) on Day 1, Day 29, and Day 57	Biological: Virosomal influenza vaccine; Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012: 15 μg 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 Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis); Other Names: Inflexal V
Experimental: Group 2; 1 x double standard dose (1.0 mL) on Day 1 and 1 x standard dose (0.5 mL) on Day 57.	Biological: Virosomal influenza vaccine; Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012: 15 μg 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 Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis); Other Names: Inflexal V
Experimental: Group 3; 1 x triple standard dose (1.5 mL) on Day 1	Biological: Virosomal influenza vaccine; Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012: 15 μg 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 Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis); Other Names: Inflexal V

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of local and systemic solicited adverse events	4 days after each vaccination (day of vaccination and the followoing 3 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of unsolicited AEs	4 weeks after each vaccination
Humoral and cellular immune response against homologous and heterologous vaccine strains	Baseline (before vacination) and Months 1, 2, 3, 4, and 12 after vaccination
Incidence of SAEs	up to 12 months after baseline

Collaborators and Investigators

• Sponsor: Crucell Holland BV
• Investigators: Study Director: Enza di Modugno, Crucell Holland

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 10, 2012
• First Submitted That Met QC Criteria: June 8, 2012
• First Posted (Estimate): June 12, 2012

Study Record Updates

• Last Update Posted (Estimate): August 20, 2014
• Last Update Submitted That Met QC Criteria: August 19, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Influenza; Vaccination; Virosomal influenza vaccine
• 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-A017; 2012-001693-28 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No