A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere

• ClinicalTrials.gov Identifier: NCT01306253
• Recruitment Status: Completed
• First Posted: March 1, 2011
• Results First Posted: January 20, 2012
• Last Update Posted: September 9, 2013
• Sponsor: Crucell Holland BV
• Information provided by (Responsible Party): Crucell Holland BV

Study Description

Brief Summary:

This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Inflexal V	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 114 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2009/2010-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations
• Study Start Date: June 2009
• Actual Primary Completion Date: June 2009
• Actual Study Completion Date: June 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Elderly; Elderly subjects aged over 60 years	Biological: Inflexal V; Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus; 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus; 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1
Experimental: Adults; Adults from 18 to 60 years old inclusive	Biological: Inflexal V; Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus; 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus; 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1

Outcome Measures

Primary Outcome Measures :

1. Seroconversion [ Time Frame: Day 22 ± 2 days ]
   Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40
2. Seroprotection [ Time Frame: Day 22 ± 2 days ]
   Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40
3. Fold Increase in Geometric Mean Titer (GMT) [ Time Frame: Day 22/Day 1 ]
   GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value

Secondary Outcome Measures :

1. Safety: Numbers of Subjects Reporting Solicited Local Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Day 22 ]
   Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
2. Numbers of Subjects Reporting Solicited Systemic Adverse Events [ Time Frame: Days 1 to 4 inclusive, and Day 22 ]
   Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Healthy female and male adults
• Aged ≥18 to ≤60 years or >60 years on Day 1
• Written informed consent

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 study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
• Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
• 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 or spouse of the investigator
• Suspected non-compliance

Contacts and Locations

Locations

Switzerland

Covance Clinical Research Unit AG

Allschwil, Switzerland, 4123

Sponsors and Collaborators

Crucell Holland BV

Investigators

• Principal Investigator: Michael Seiberling, MD; Covance Clinical Research Unit AG

More Information

• Responsible Party: Crucell Holland BV
• ClinicalTrials.gov Identifier: NCT01306253
• Other Study ID Numbers: INF-V-A003
• First Posted: March 1, 2011
• Results First Posted: January 20, 2012
• Last Update Posted: September 9, 2013
• Last Verified: August 2013

Keywords provided by Crucell Holland BV:

Influenza; Virus; Vaccination; Immunisation

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases