A phase II randomized study to determine the safety and immunogenicity of the novel PIKA rabies vaccine containing the PIKA adjuvant using an accelerated regimen

Article ID	Journal	Published Year	Pages	File Type
8486432	Vaccine	2017	6 Pages	PDF

Abstract

Clinical trial registry: The study was registered with clinicaltrials.gov (NCT02956421).

Keywords

RFFIT rabies immunoglobulin RIG HSA FAS CSIRO SAE GMP GMT eCRF PEP MedDRA CTCAE TLR3 Safety Immunogenicity ACIP Good Manufacturing Practice IMU Medical Dictionary for Regulatory Activities World Health Organization Commonwealth Scientific and Industrial Research Organization Pika adverse event Serious adverse event confidence interval Phase II Common Terminology Criteria for Adverse Events Geometric mean titer Rabies vaccine Post-exposure prophylaxis Advisory Committee on Immunization Practices WHO Toll-like receptor 3

Related Topics

Life Sciences Immunology and Microbiology Immunology

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A phase II randomized study to determine the safety and immunogenicity of the novel PIKA rabies vaccine containing the PIKA adjuvant using an accelerated regimen

Authors

Shirin Kalimuddin, Limin Wijaya, Yvonne F.Z. Chan, Abigail W.L. Wong, Helen M.L. Oh, Lin-Fa Wang, Julaihabee A. Kassim, Jing Zhao, Zhongkai Shi, Jenny G. Low,