Clinical trial NCT00415129: Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Orthomyxoviridae Infections
Keywords: Influenza
Orthomyxoviridae Infections
Influenza Pandemics
A/H5N1 strain
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-12-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (\> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.


Eligibility criteria: Inclusion Criteria :

* Aged over 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
* For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination.

Exclusion Criteria :

* Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances
* Febrile illness (oral temperature ≥ 37.5°C) on the day of inclusion
* Breast-feeding
* Previous vaccination with an avian flu vaccine
* Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
* Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders)
* Current alcohol or drug abuse that may interfere with the subject's ability to comply with trial procedures
* Receipt of blood or blood-derived products within the past 3 months
* Any vaccination within 4 weeks prior to the first trial vaccination
* Vaccination planned within 4 weeks after any trial vaccination
* 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.

Primary outcomes:
measure: To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine
timeFrame: 21 Days post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
city: Leuven
country: Belgium
city: Wilrijk
country: Belgium
city: Oxford
country: United Kingdom
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lazarus R, Kelly S, Snape MD, Vandermeulen C, Voysey M, Hoppenbrouwers K, Hens A, Van Damme P, Pepin S, Leroux-Roels I, Leroux-Roels G, Pollard AJ. Antibody Persistence and Booster Responses to Split-Virion H5N1 Avian Influenza Vaccine in Young and Elderly Adults. PLoS One. 2016 Nov 4;11(11):e0165384. doi: 10.1371/journal.pone.0165384. eCollection 2016.
citation: Leroux-Roels I, Van der Wielen M, Kafeja F, Vandermeulen C, Lazarus R, Snape MD, John T, Carre C, Nougarede N, Pepin S, Leroux-Roels G, Hoppenbrouwers K, Pollard AJ, Van Damme P. Humoral and cellular immune responses to split-virion H5N1 influenza vaccine in young and elderly adults. Vaccine. 2009 Nov 16;27(49):6918-25. doi: 10.1016/j.vaccine.2009.08.110. Epub 2009 Sep 15.