A Study of the Immunogenicity and Safety of the 2006-2007 Influenza Vaccine

This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency.

The objectives of the trial are:

* To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2006-2007 formulation with the requirements of the European Medicines Agency * To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2006-2007 formulation.

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Key information

Conditions

Influenza 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 2

Primary location

Allschwil, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Aged at least 18 years on the day of inclusion
Informed consent form signed
Able to attend all scheduled visits and to comply with all trial procedures
For a woman, inability to bear a child or negative urine pregnancy test at Visit 1
For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least three weeks after vaccination.

Exclusion criteria

Febrile illness (oral temperature >=37.5°C) on the day of vaccination
Breast-feeding
Participation in another clinical trial in the four weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy
Systemic hypersensitivity to egg proteins, chick proteins, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
Chronic illness at a stage that could interfere with trial conduct or completion
Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures
Blood or blood-derived products received in the past three months
Any vaccination in the four weeks preceding the trial vaccination
Vaccination planned in the three weeks following the trial vaccination
Vaccination against influenza in the previous six months
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent

Treatment and study plan

Inactivated influenza vaccine (split virion)

Biological

0.5 mL, Intramuscular

Primary outcomes

To provide information concerning the immunogenicity of inactivated influenza vaccine (split virion)

Time frame: 21 Days post-vaccination

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2006-2007 Formulation (Intramuscular Route)

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Jun 23, 2006
Registry last updated: Jan 17, 2014

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.

Published trials that share one or more normalized conditions with this study.

Completed