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Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine

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ClinicalTrials.gov Identifier: NCT01617239
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Virosomal influenza vaccine Phase 1

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  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2012
Primary Completion Date : June 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. Incidence of local and systemic solicited adverse events [ Time Frame: 4 days after each vaccination (day of vaccination and the followoing 3 days) ]

Secondary Outcome Measures :
  1. Incidence of unsolicited AEs [ Time Frame: 4 weeks after each vaccination ]
  2. 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 ]
  3. Incidence of SAEs [ Time Frame: up to 12 months after baseline ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01617239     History of Changes
Other Study ID Numbers: INF-V-A017
2012-001693-28 ( EudraCT Number )
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs