A Phase II, Open Label Study to Evaluate the Immunogenicity, Tolerability and Safety of a MF59-Adjuvanted, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy...

Update Il y a 5 ans
Reference: EUCTR2009-013904-30

A Phase II, Open Label Study to Evaluate the Immunogenicity, Tolerability and Safety of a MF59-Adjuvanted, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 Years and Above

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Extract

To evaluate the immunogenicity of one and two intramuscular (IM) injections of the MF59-adjuvanted H1N1sw monovalent influenza vaccine in adult and elderly subjects previously exposed to 2009/10 NH formulation of TIV and in those not yet vaccinated against seasonal influenza 2009/10, with respect to CHMP criteria. To evaluate immunogenicity of one and two IM injections of full and half dose of a H1N1sw monovalent influenza vaccine concomitantly administered with a single IM dose of a seasonal TIV in adult subjects not yet vaccinated against seasonal influenza 2009/10, with respect to CHMP criteria. To evaluate immunogenicity of a single IM injection of a seasonal TIV when concomitantly administered with one and two IM injections of full and half dose of a H1N1sw monovalent influenza vaccine in adult subjects not yet vaccinated against seasonal influenza 2009/10, with respect to CHMP criteria.


Inclusion criteria

  • Evaluate the Immunogenicity, Tolerability and Safety of a MF59-Adjuvanted, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects Aged 18 Years and Above

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