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Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Subjects Aged 6 to ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-013858-32

Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Subjects Aged 6 to 35 Months

Femme et Homme

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Extrait

• To describe the immune response of each candidate vaccine 21 days after each vaccination by hemagglutination inhibition (HAI) and seroneutralization (SN) testing in all subjects. • To describe the antibody persistence eight months (M8) after the first vaccine administration using HAI method in a subset of subjects who received two half doses of either the 15 μg HA or 3.8 μg HA + AF03 vaccine (amendment 2). • To describe the safety profiles (injection site reactions, and systemic events) of each candidate vaccine during the 21 days following each vaccination, and serious adverse events throughout the study in all subjects •To describe the immune response against the A/H1N1 strain using the HAI method 21 days after last vaccination with the 2010-2011 NH seasonal TIV administered 13 months after the first vaccination in a subset of subjects who received two half-doses of either the 15 µg HA or 3.8 µg HA + AF03 A/H1N1 influenza vaccines as primary series (amendment 3).

Critère d'inclusion

  • Preventive vaccination in healthy subjects aged 6 to 35 months against infection with S-OIV (Swine Origin Influenza Virus) A/California/7/2009 (H1N1)

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