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Vaccine Volume 41, Issue 42, 6 October 2023, Pages 6215-6220 Keywords Havisure™ vaccine Havrix® vaccine Safety Immunogenicity Non-inferiority Abbreviations CTCAE Common Terminology Criteria for Adverse Events HBI Human Biologicals Institute LAR Legally Acceptable Representative MedDRA Medical Dictionary for Regulatory Activities 1. Introduction Hepatitis A is an inflammatory liver disease caused by the Hepatitis A virus (HAV).
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