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Q-Pan, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
申请企业
ID Biomedical Corporation of Quebec
药品名称
Q-Pan, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
承诺描述
Establish a pregnancy registry in the U.S. that is able to prospectively collect data on an actively recruited cohort to study the safety of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted during pregnancy. A concept protocol for this pregnancy registry will be prepared under the assumption that the vaccine would be distributed to the general population in the U.S. in an officially-declared H5N1 influenza virus pandemic. Once the circumstances of the vaccine use in an officially-declared H5N1 influenza virus pandemic are determined by the U.S. Government, you will work with the FDA to finalize the protocol and you will initiate the registry.