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

Influenza Clinical Trial

Official title:

Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2013/2014-season Virosomal Subunit Influenza Vaccine in Elderly and Young Subjects According to EMA Regulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893177
• Other study ID #: INF-V-A018
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2013
• Last updated: August 29, 2013
• Start date: July 2013
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
Switzerland	CROSS Research S.A. - Phase I Unit	Arzo

Sponsors (1)

Lead Sponsor	Collaborator
Crucell Holland BV

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of solicited local adverse events		Days 1 to 4 inclusive	Yes
Secondary	Incidence of solicited systemic adverse events		Days 1 to 4 inclusive	Yes
Secondary	Incidence of unsolicited adverse events		Days 1 to 22 inclusive	Yes