Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains (2013-14)

NCT01893177 | Completed Phase 3

• 1 other identifier: INF-V-A018
• 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 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.

Conditions

Influenza

Keywords

Influenza; Virus; Vaccination; Inflexal V

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT)

  Immunogenicity variables are analyzed according to the EMA re-licensing criteria; at least one of the criteria has to be fulfilled for each vaccine strain: * Seroconversion rate at Day 22 has to be \>40% of subjects aged ≥18 to ≤60 years and \>30% of subjects aged \>60 years, or * Seroprotection rate at Day 22 has to be \>70% of subjects aged ≥18 to ≤60 years and \>60% of subjects aged \>60 years, or * GMT-fold increase at Day 22 compared to baseline: a \>2.5-fold increase has to be reached in subjects aged ≥18 to ≤60 years and a \>2.0-fold increase has to be reached in subjects aged \>60 years

  Day 22 +/- 2 days

Secondary Outcomes (3)

• Incidence of solicited local adverse events

  Days 1 to 4 inclusive

• Incidence of solicited systemic adverse events

  Days 1 to 4 inclusive

• Incidence of unsolicited adverse events

  Days 1 to 22 inclusive

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 2013-2014 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/Texas/50/2012 (H3N2)-like virus, • 15 µg HA antigen of B/Massachusetts/2/2012-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)

CROSS Research S.A. - Phase I Unit

Arzo, 6864, 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

Study Officials

• Milko Radicioni, MD

  Cross Research S.A.

  PRINCIPAL INVESTIGATOR

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: July 2, 2013
• First Posted: July 8, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

CH (1)