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

Study Description

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Crucell Holland BV
ClinicalTrials.gov Identifier:	NCT01306253 History of Changes
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