Viewing Study NCT03231605


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Study NCT ID: NCT03231605
Status: UNKNOWN
Last Update Posted: 2017-08-01
First Post: 2017-07-20
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Comparative Immunogenicity Study of Two Hepatitis A Vaccines
Sponsor: China National Biotec Group Company Limited
Organization:

Study Overview

Official Title: Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines
Status: UNKNOWN
Status Verified Date: 2017-07
Last Known Status: ENROLLING_BY_INVITATION
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important role in National Immunisation Program(China). The aim of this experiment is to verify the effects of experimental group non-inferior than control group. The experiment methods is compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two Hepatitis A Vaccines in 18-24 months Chinese Children.
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: