Virus Diseases Clinical Trial
Official title:
A Phase IV, Open Label, Single-center Extension Study, to Evaluate the Long-term Persistence of Immune Responses After Post-exposure Prophylaxis With Purified Chicken-embryo Cell Rabies Vaccine in Chinese Children
The purpose of this study is to evaluate the long-term persistence of immune responses
approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in
2012 according to Essen (1-1-1-1-1) or Zagreb (2-1-1) intramuscular (IM) regimens in the
subset of subjects who participated in the parent study (V49_24 [NCT01680016]) who were aged
≥6 and ≤17 years at the time of enrollment.
This study is aimed to respond to a post-marketing commitment by the China Food and Drug
Administration (CFDA) requested at the time of the renewal of the purified chicken-embryo
cell rabies vaccine license in China, granted in August 2015.
n/a
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