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Flucelvax Quadrivalent, Influenza Vaccine
药品名称
Flucelvax Quadrivalent, Influenza Vaccine
承诺描述
To establish a pregnancy registry to prospectively collect data on spontaneously-reported exposures to Flucelvax® Quadrivalent or Flucelvax® during pregnancy and collect data on pregnancy outcomes. When the registry has enrolled a minimum of 600 evaluable subjects and collected data on the outcomes specified in the protocol, Seqirus will submit a full study report and continue enrolling in the registry pending CBER review and discussion of registry results with Seqirus.