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A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere

Primary Purpose

Influenza

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Inflexal V

About this trial

This is an interventional treatment trial for Influenza focused on measuring Influenza, Virus, Vaccination, Immunisation

Eligibility Criteria

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

Inclusion Criteria:

Healthy female and male adults
Aged ≥18 to ≤60 years or >60 years on Day 1
Written informed consent

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 study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
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 or spouse of the investigator
Suspected non-compliance

Sites / Locations

Covance Clinical Research Unit AG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Elderly

Adults

Arm Description

Elderly subjects aged over 60 years

Adults from 18 to 60 years old inclusive

Outcomes

Primary Outcome Measures

Seroconversion

Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40

Seroprotection

Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40

Fold Increase in Geometric Mean Titer (GMT)

GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value

Secondary Outcome Measures

Safety: Numbers of Subjects Reporting Solicited Local Adverse Events

Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination

Numbers of Subjects Reporting Solicited Systemic Adverse Events

Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination

Full Information

NCT ID

NCT01306253

First Posted

February 28, 2011

Last Updated

August 29, 2013

Sponsor

Crucell Holland BV

1. Study Identification

Unique Protocol Identification Number

NCT01306253

Brief Title

A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere

Official Title

Open, Non-randomized Trial to Assess the Immunogenicity and Safety of the 2009/2010-season Influenza Vaccine in Elderly and Young Subjects According to European Medicines Agency (EMEA) Regulations

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (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

This study is to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V fulfills the EMEA 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, Immunisation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

114 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Elderly

Arm Type

Experimental

Arm Description

Elderly subjects aged over 60 years

Arm Title

Adults

Arm Type

Experimental

Arm Description

Adults from 18 to 60 years old inclusive

Intervention Type

Biological

Intervention Name(s)

Inflexal V

Intervention Description

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1

Primary Outcome Measure Information:

Title

Seroconversion

Description

Seroconversion rate was defined as the number of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40

Time Frame

Day 22 ± 2 days

Title

Seroprotection

Description

Seroprotection rate, defined as the number of subjects with HI antibody titer ≥1:40

Time Frame

Day 22 ± 2 days

Title

Fold Increase in Geometric Mean Titer (GMT)

Description

GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value

Time Frame

Day 22/Day 1

Secondary Outcome Measure Information:

Title

Safety: Numbers of Subjects Reporting Solicited Local Adverse Events

Description

Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination

Time Frame

Days 1 to 4 inclusive, and Day 22

Title

Numbers of Subjects Reporting Solicited Systemic Adverse Events

Description

Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination

Time Frame

Days 1 to 4 inclusive, and Day 22

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 to ≤60 years or >60 years on Day 1 Written informed consent 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 study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed) Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity) 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 or spouse of the investigator Suspected non-compliance

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Seiberling, MD

Organizational Affiliation

Covance Clinical Research Unit AG

Official's Role

Principal Investigator

Facility Information:

Facility Name

Covance Clinical Research Unit AG

City

Allschwil

ZIP/Postal Code

4123

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2009/2010 Influenza Virus Strains for the Northern Hemisphere

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