Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains

NCT01631110 | Completed Phase 3 Results

• 1 other identifier: INF-V-A010
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.

Conditions

Influenza

Keywords

Influenza; Virus; Vaccination; Inflexal V

Outcome Measures

Primary Outcomes (3)

• Seroprotection

  Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

  Day 22 +/- 2 days

• Seroconversion

  Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

  Day 22 +/- 2 days

• Geometric Mean Titer

  GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)

  Day 22 +/- 2 days

Secondary Outcomes (1)

• Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability

  Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)

Study Arms (2)

Elderly subjects aged over 60 years

EXPERIMENTAL

Biological: Inflexal V

Adults from 18 to 60 years old inclusive

EXPERIMENTAL

Biological: Inflexal V

Interventions

Inflexal V BIOLOGICAL

Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V

Also known as: Inflexal V influenza vaccine (surface antigen, inactivated, virosome) formulated for the WHO requirements of the 2012-2013 season, each 0.5 mL dose containing:, • 15 µg HA antigen of A/California/7/2009 (H1N1)-like virus, • 15 µg HA antigen of A/Victoria/361/2011 (H3N2)-like virus, • 15 µg HA antigen of B/Wisconsin/1/2010-like virus

Adults from 18 to 60 years old inclusive; Elderly subjects aged over 60 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female and male adults aged ≥18 on Day 1
• 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

You may not qualify if:

• 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 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), cancer
• 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 of the investigator
• Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol

Sponsors & Collaborators

• Crucell Holland BV: lead

Study Sites (1)

Covance Clinical Research Unit AG

Allschwil, 4123, Switzerland

Location

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Interventions

Inflexal V; Antigens, Surface; Virosomes

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors; Membranes, Artificial; Biomedical and Dental Materials; Drug Carriers; Dosage Forms; Pharmaceutical Preparations; Manufactured Materials; Technology, Industry, and Agriculture; Biomimetic Materials

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Crucell Switzerland AG

info@crucell.com

+41(0)319806111

Study Officials

• Michael Seiberling, MD

  Covance Clinical Research Unit AG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: June 28, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 20, 2013
• Results First Posted: December 20, 2013

Record last verified: 2013-08

Locations

CH (1)