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Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 08/09 Season.

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Trivalent influenza subunit vaccine Influvac

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Willing and able to give informed consent and able to adhere to all protocol required study procedures.
Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
Having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period.
A history of Guillain-Barré syndrome or active neurological disease.

Sites / Locations

Site 1
Site 2

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2008/2009

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00665509

First Posted

April 10, 2008

Last Updated

August 12, 2008

Sponsor

Solvay Biologicals

1. Study Identification

Unique Protocol Identification Number

NCT00665509

Brief Title

Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 08/09 Season.

Official Title

Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2008/2009. An Open-Label, Baseline-Controlled Multi-Center Study in Two Groups: Adult Subjects and Elderly Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Solvay Biologicals

4. Oversight

Data Monitoring Committee

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

Influenza

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 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Trivalent influenza subunit vaccine Influvac

Intervention Description

3x 15mcg HA per 0.5 ml, trivalent one injection at Day 1

Primary Outcome Measure Information:

Title

Immunogenicity (HI-titers after 2 and 3 weeks), reactogenicity and inconvenience of Influvac® 2008/2009

Time Frame

2 and 3 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

2 and 3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Willing and able to give informed consent and able to adhere to all protocol required study procedures. Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator. Exclusion Criteria: Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator. Having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period. A history of Guillain-Barré syndrome or active neurological disease.

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

Facility Name

Site 2

City

Hamburg

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 08/09 Season.

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