Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2010/2011 Season

NCT ID: NCT01146015

Last Updated: 2011-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2010-07-31

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 subjects in good health: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly)

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Trivalent influenza subunit vaccine Influvac

Intervention Type: BIOLOGICAL

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

Interventions

Trivalent influenza subunit vaccine Influvac

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.

2. Men and women aged >= 18 and <= 60 years or >= 61 years of age at the day of study vaccination.

3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator

Exclusion Criteria

1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.

2. A serious adverse reaction after a previous (influenza) vaccination.

3. Presence of any significant condition that may prohibit inclusion as determined by the investigator.

4. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period.

5. A history of Guillain-Barré syndrome or active neurological disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Abbott Biologicals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanka de Voogd, MD

Role: STUDY_DIRECTOR

Abbott Healthcare Products B.V.

Locations

Site Reference ID/Investigator# 44974

Tessenderlo, , Belgium

Site Reference ID/Investigator# 44975

Hamburg, , Germany

Countries

Belgium; Germany

Other Identifiers

2010-018350-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S201.3.130

Identifier Type: -

Identifier Source: org_study_id