drugset

drugset / Trial / NCT02601040

Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

NCT02601040 ↗

Phase 4 Completed 13500 enrolled Jiangsu Province Centers for Disease Control and Prevention Institute of Medical Biology, Chinese Academy of Medical Sciences · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people.

Timeline

Start: 2011-11
Primary completion: 2014-06
Completion: 2015-10

Publications

Wang X, Luo J, Ma F, Kang G, Ding Z, Pan Y, Zhao Y, Chen J, Feng K, Yan L, Zhang J, Li L, Lan Q, Li D, Yang X, Li G, Yang J, Sun Q. The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study. Front Cell Infect Microbiol. 2021 Jun 17;11:672221. doi: 10.3389/fcimb.2021.672221. eCollection 2021.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Attenuated Hepatitis A Vaccine, H2 Strain	Vaccine	6.5 unknown	Intramuscular
Subject	Inactivated Hepatitis A Vaccine, Lu8 Strain	Vaccine	320 unknown	Intramuscular
Subject	Inactivated Hepatitis A Vaccine, Lu8 Strain	Vaccine	640 unknown	Intramuscular
Comparator	Group A meningococcal polysaccharide vaccine	Vaccine	30 ug	Intramuscular

Indications