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A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and non Adjuvanted Cell-derived, Inactivated Novel Swine Orig...

Update Il y a 5 ans
Reference: EUCTR2009-013640-37

A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and non Adjuvanted Cell-derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects from 6 Months to 17 Years of Age

Woman and Man

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Extract

To identify the preferred vaccine formulation (with or without MF59), dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy children and adolescents based on CHMP criteria and pairwise statistical comparisons for immunogenicity, safety and tolerability.

Inclusion criteria

  • Pandemic influenza

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