Safety and Immunogenicity of an Intramuscular H5N1 Inactivated, Split Virion Influenza Vaccine Adjuvanted with AF03 in Adults and Elderly subjects

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-019835-37

Femme et Homme

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Extrait

• To describe the safety profile of the vaccines (injection site reactions and systemic events) either 21 days after each injection in subjects vaccinated following the D0-D21 or D0-D42 schedules or, 14 days and 21 days after the first and second injection respectively, in subjects vaccinated following the D0-D14 schedule • To describe the immunogenicity 21 days after each vaccine injection in a randomized subset of subjects vaccinated following the D0-D21 schedule and participating to immunogenicity evaluation • To describe the persistence of antibodies (Ab) 6 and 12 months after the second vaccine injection in the randomized subset of subjects vaccinated following the D0-D21 schedule and participating to immunogenicity evaluation.


Critère d'inclusion

  • Preventive vaccination study in healthy subjects aged 18-60 years and over 60 years against infection with H5N1 Influenza Virus A/Indonesia/5/05-RG2 (H5N1)