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A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine with or...

Mise à jour : Il y a 5 ans
Référence : EUCTR2008-002602-20

A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine with or without a Second Influenza B Strain in Combination with or without One of Three Different Doses of Adjuvant in Healthy Children, Ages 6 to <36 Months

Femme et Homme

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Extrait

Evaluate safety and tolerability of the study vaccines described below as compared to one and two 0.25 mL IM doses of trivalent inactivated influenza vaccine (TIV) and as compared to a marketed trivalent inactivated influenza vaccine: A. One and/or two 0.25 or 0.50 mL IM doses of quadrivalent influenza vaccine (TIV formulated with a second B strain; hereafter referred to as QIV). B. One and/or two 0.25 or 0.50 mL IM doses of TIV formulated with no dose, eighth dose, quarter dose, half dose, or full dose of adjuvant (MF59). C. One and/or two 0.25 or 0.50 mL IM doses of QIV formulated with either 0, quarter dose, half dose, or full dose of adjuvant (MF59). in unprimed healthy children aged 6 months to <36 months. Safety will be evaluated by collection of spontaneously reported adverse events (AEs) and tolerability will be evaluated by collection of solicited injection site reactions and solicited systemic reactions

Critère d'inclusion

  • Seasonal Influenza

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