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Completed

NCT Number: NCT00346723

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

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).

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Key information

Conditions

Healthy Volunteers Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 1

Tessenderlo, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Biological

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2006
First posted
Jun 30, 2006
Registry last updated
Jan 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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