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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00665509

Enrollment

120

Registered

2008-04-24

Start date

2008-06-30

Completion date

2008-07-31

Last updated

2008-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, Vaccine, CHMP criteria

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).

Interventions

BIOLOGICALTrivalent influenza subunit vaccine Influvac

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
HI derived parameters: seroprotection, seroconversion and mean fold increase (CHMP)	2 and 3 weeks

Countries

Belgium, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026