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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

Inflexal V

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Virus, Vaccination, Inflexal V

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CROSS Research S.A. - Phase I Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Elderly subjects aged over 60 years

Adults from 18 to 60 years old inclusive

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of solicited local adverse events

Incidence of solicited systemic adverse events

Incidence of unsolicited adverse events

Full Information

NCT ID

NCT01893177

First Posted

July 2, 2013

Last Updated

August 29, 2013

Sponsor

Crucell Holland BV

1. Study Identification

Unique Protocol Identification Number

NCT01893177

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Crucell Holland BV

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Virus, Vaccination, Inflexal V

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Elderly subjects aged over 60 years

Arm Type

Experimental

Arm Title

Adults from 18 to 60 years old inclusive

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Inflexal V

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Day 22 +/- 2 days

Secondary Outcome Measure Information:

Title

Incidence of solicited local adverse events

Time Frame

Days 1 to 4 inclusive

Title

Incidence of solicited systemic adverse events

Time Frame

Days 1 to 4 inclusive

Title

Incidence of unsolicited adverse events

Time Frame

Days 1 to 22 inclusive

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Milko Radicioni, MD

Organizational Affiliation

Cross Research S.A.

Official's Role

Principal Investigator

Facility Information:

Facility Name

CROSS Research S.A. - Phase I Unit

City

Arzo

ZIP/Postal Code

6864

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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