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Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01617239
First received: May 10, 2012
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza
 Biological: Virosomal influenza vaccine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I, Open Label, Randomized Study in Healthy Adults to Compare Safety and Immunogenicity of Different Administration Schedules of Virosomal Influenza Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • Incidence of local and systemic solicited adverse events [ Time Frame: 4 days after each vaccination (day of vaccination and the followoing 3 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of unsolicited AEs [ Time Frame: 4 weeks after each vaccination ] [ Designated as safety issue: Yes ]
  • Humoral and cellular immune response against homologous and heterologous vaccine strains [ Time Frame: Baseline (before vacination) and Months 1, 2, 3, 4, and 12 after vaccination ] [ Designated as safety issue: No ]
  • Incidence of SAEs [ Time Frame: up to 12 months after baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 84
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Inflexal V

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617239

Locations
Belgium
Center for the Evaluation of Vaccination, Unit of Epidemiology and Social Medicine, University of Antwerp
Antwerp, Belgium, 2610
Sponsors and Collaborators
Crucell Holland BV
Investigators
Study Director: Enza di Modugno Crucell Holland
  More Information

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01617239     History of Changes
Other Study ID Numbers: INF-V-A017, 2012-001693-28
Study First Received: May 10, 2012
Last Updated: February 19, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Crucell Holland BV:
Influenza
Vaccination
Virosomal influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013