NCT03231605

Comparative Immunogenicity Study of Two Hepatitis A Vaccines

Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: China National Biotec Group Company Limited · Industry
• Sex: All
• Age: 18 Months – 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Hepatitis A Vaccine	Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .

Timeline

• Start date: 2017-07-26
• Primary completion: 2017-08-31
• Completion: 2017-12-29
• First posted: 2017-07-27
• Last updated: 2017-08-01

Locations

1 site across 1 country: China