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Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine

Primary Purpose

Influenza

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Virosomal influenza vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccination, Virosomal influenza vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy male and female adults
Aged ≥ 18 to ≤ 50 years on the day of enrollment
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
Body weight below 40 kg at any visit during the study
Acute febrile illness (≥ 38.0°C)
Known hypersensitivity to any vaccine component
Previous history of a serious adverse reaction to influenza vaccine
Previous vaccination with a seasonal influenza vaccine for season 2011-2012 or a virosomal formulation of seasonal influenza vaccine in any season
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) or cancer
Known history of psychiatric diseases, particularly dementia
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 for the entire duration of this trial
Employee at the investigational site or relative of the investigator
Subjects who in the view of investigator will not comply with study procedure and/or visit requirements as per protocol

Sites / Locations

Center for the Evaluation of Vaccination, Unit of Epidemiology and Social Medicine, University of Antwerp

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

1 x standard dose (0.5 mL) on Day 1, Day 29, and Day 57

1 x double standard dose (1.0 mL) on Day 1 and 1 x standard dose (0.5 mL) on Day 57.

1 x triple standard dose (1.5 mL) on Day 1

Outcomes

Primary Outcome Measures

Incidence of local and systemic solicited adverse events

Secondary Outcome Measures

Incidence of unsolicited AEs

Humoral and cellular immune response against homologous and heterologous vaccine strains

Incidence of SAEs

Full Information

NCT ID

NCT01617239

First Posted

May 10, 2012

Last Updated

August 19, 2014

Sponsor

Crucell Holland BV

1. Study Identification

Unique Protocol Identification Number

NCT01617239

Brief Title

Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine

Official Title

A Phase I, Open Label, Randomized Study in Healthy Adults to Compare Safety and Immunogenicity of Different Administration Schedules of Virosomal Influenza Vaccine

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

December 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 goal of the study is to assess the safety and immune response after vaccination with different doses and vaccination schedules of virosomal influenza vaccine.

Detailed Description

Virosomal influenza vaccine is usually administered intramuscularly as a single 0.5 mL dose. The aim of this study is to evaluate the safety and immunogenicity of different doses and vaccination schedules. A total of 84 healthy adults aged 18-50 years will be randomized (1:1:1) into 3 treatment groups: subjects of group 1 will receive a standard dose (0.5 mL) at Days 1, 29, and 57; subjects of group 2 will receive a double dose (1.0 mL) at Day 1 and a standard dose (0.5 mL) at Day 57; subjects of group 3 will receive a triple dose (0.5 mL) at Day 1. Local and systemic solicited adverse events up to Day 4 after each vaccination will be documented. To assess the subjects' humoral and cellular immune response against homologous and heterologous virus strains, blood will be drawn from each participant at baseline (Day 1), at the 4 subsequent monthly visits (Months 1 to 4) and at Month 12.

6. Conditions and Keywords

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

Influenza

Keywords

Influenza, Vaccination, Virosomal influenza vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

1 x standard dose (0.5 mL) on Day 1, Day 29, and Day 57

Arm Title

Group 2

Arm Type

Experimental

Arm Description

1 x double standard dose (1.0 mL) on Day 1 and 1 x standard dose (0.5 mL) on Day 57.

Arm Title

Group 3

Arm Type

Experimental

Arm Description

1 x triple standard dose (1.5 mL) on Day 1

Intervention Type

Biological

Intervention Name(s)

Virosomal influenza vaccine

Other Intervention Name(s)

Inflexal V

Intervention Description

Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus 15 μg HA antigen of B/Brisbane/60/2008-like virus Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)

Primary Outcome Measure Information:

Title

Incidence of local and systemic solicited adverse events

Time Frame

4 days after each vaccination (day of vaccination and the followoing 3 days)

Secondary Outcome Measure Information:

Title

Incidence of unsolicited AEs

Time Frame

4 weeks after each vaccination

Title

Humoral and cellular immune response against homologous and heterologous vaccine strains

Time Frame

Baseline (before vacination) and Months 1, 2, 3, 4, and 12 after vaccination

Title

Incidence of SAEs

Time Frame

up to 12 months after baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male and female adults Aged ≥ 18 to ≤ 50 years on the day of enrollment 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 Body weight below 40 kg at any visit during the study Acute febrile illness (≥ 38.0°C) Known hypersensitivity to any vaccine component Previous history of a serious adverse reaction to influenza vaccine Previous vaccination with a seasonal influenza vaccine for season 2011-2012 or a virosomal formulation of seasonal influenza vaccine in any season 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) or cancer Known history of psychiatric diseases, particularly dementia 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 for the entire duration of this trial Employee at the investigational site or relative of the investigator Subjects who in the view of investigator will not comply with study procedure and/or visit requirements as per protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enza di Modugno

Organizational Affiliation

Crucell Holland

Official's Role

Study Director

Facility Information:

Facility Name

Center for the Evaluation of Vaccination, Unit of Epidemiology and Social Medicine, University of Antwerp

City

Antwerp

ZIP/Postal Code

2610

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine

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