Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine

NCT ID: NCT01617239

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-12-31

Brief Summary

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.

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

1 x standard dose (0.5 mL) on Day 1, Day 29, and Day 57

Group Type: EXPERIMENTAL

Virosomal influenza vaccine

Intervention Type: BIOLOGICAL

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)

Group 2

1 x double standard dose (1.0 mL) on Day 1 and 1 x standard dose (0.5 mL) on Day 57.

Group Type: EXPERIMENTAL

Virosomal influenza vaccine

Intervention Type: BIOLOGICAL

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)

Group 3

1 x triple standard dose (1.5 mL) on Day 1

Group Type: EXPERIMENTAL

Virosomal influenza vaccine

Intervention Type: BIOLOGICAL

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)

Interventions

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)

Intervention Type: BIOLOGICAL

Other Intervention Names

Inflexal V

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Crucell Holland BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enza di Modugno

Role: STUDY_DIRECTOR

Crucell Holland

Locations

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

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

2012-001693-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INF-V-A017

Identifier Type: -

Identifier Source: org_study_id