Safety, Immunogenicity, and Immune Persistence Study of an Inactivated Hepatitis A Vaccine

Summary

A double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A vaccine (Healive®). Participants who completed their primary vaccination were invited to participate in the follow-up phase. Written informed consents were obtained from them. The follow-up study was open-label. These subjects were visited in the next 11 years for blood sampling and assessment of immune persistence induced by vaccination.

Timeline

Start

2006-03

Primary completion

2017-10

Completion

2017-10

Drugs

Indications