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

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: Inflexal V

• Registration Number: NCT01893177
• Lead Sponsor: Crucell Holland BV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-08
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-29
• Last Update Posted: 2013-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elderly subjects aged over 60 years	Inflexal V	-
Adults from 18 to 60 years old inclusive	Inflexal V	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT)	Day 22 +/- 2 days	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CROSS Research S.A. - Phase I Unit; 🇨🇭 Arzo, Switzerland