Annual Study to Investigate Inactivated Subunit Influenza Vaccine for the 2006/2007 Influenza Season in Europe.

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

Influvac® subunit influenza vaccine for i.m./deep s.c.injection

About this trial

This is an interventional prevention trial for Healthy Volunteers focused on measuring Influenza, Vaccine, CHMP criteria

Eligibility Criteria

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

Inclusion Criteria: Signed and dated informed consent. Healthy and aged >= 18 and <= 60 years or >= 61 years of age. Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire. Exclusion Criteria: Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways. Having experienced a documented serious systemic reaction after previous influenza vaccination. Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage. Having received vaccination against influenza within the previous six months before Visit 1. Exclusion criteria only for female subjects aged >=18 and <=60 years and of childbearing potential: Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding. Absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).

Sites / Locations

Site 1

Outcomes

Primary Outcome Measures

Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2006/2007

Secondary Outcome Measures

HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)

Full Information

NCT ID

NCT00346723

First Posted

June 29, 2006

Last Updated

January 29, 2009

Sponsor

Solvay Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00346723

Brief Title

Annual Study to Investigate Inactivated Subunit Influenza Vaccine for the 2006/2007 Influenza Season in Europe.

Official Title

Immunogenicity and Reactogenicity of Trivalent Influenza Subunit Vaccine Influvac® for the Season 2006/2007. An Open, Baseline-Controlled Study in Two Groups of Healthy Subjects: Adults and Elderly.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Solvay Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).

6. Conditions and Keywords

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

Healthy Volunteers

Keywords

Influenza, Vaccine, CHMP criteria

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Influvac® subunit influenza vaccine for i.m./deep s.c.injection

Primary Outcome Measure Information:

Title

Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2006/2007

Secondary Outcome Measure Information:

Title

HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed and dated informed consent. Healthy and aged >= 18 and <= 60 years or >= 61 years of age. Mental health good enough to understand the study and the informed consent form and to fill in the questionnaire. Exclusion Criteria: Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. Having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways. Having experienced a documented serious systemic reaction after previous influenza vaccination. Having an auto-immune disorder (e.g. RA, SLE, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage. Having received vaccination against influenza within the previous six months before Visit 1. Exclusion criteria only for female subjects aged >=18 and <=60 years and of childbearing potential: Pregnancy (positive urine pregnancy test on Day 1) or breastfeeding. Absence of use of a medically accepted method of birth control (i.e. oral contraceptive, Intra Uterine Device, double barrier method).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Director Solvay

Organizational Affiliation

Solvay Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Site 1

City

Tessenderlo

Country

Belgium

Healthy Volunteers

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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