NCT01252680

Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines

A Randomized, Double-blind Clinical Trial of Two Inactivated Hepatitis A Vaccines in Healthy Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Months – 5 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A vaccines were evaluated.

Detailed description

This was a monocenter, comparative trial in which healthy children were randomized to receive two doses of hepatitis A vaccine 6 months apart. The trial was conducted in accordance with the Edinburgh version of the Declaration of Helsinki. The study was approved by the Ethics Committee. Parents or legal guardians of all participants gave written informed consent prior to study entry. Eligible subjects were between 18m and 6 years of age, When enrolled, children were randomized to four equal groups with different intervention. Immunogenicity and interchangeability of two inactivated hepatitis A vaccines were evaluated.

Conditions

• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Healive+Healive	Hepatitis A vaccine (Healive), 250 u per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart
BIOLOGICAL	Healive+Havrix	Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Healive, followed by another dose of Havrix after 6 months
BIOLOGICAL	Havrix+Havrix	Hepatitis A vaccine (Havrix), 720 ELU per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart
BIOLOGICAL	Havrix+Healive	Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Havrix, followed by another dose of Healive after 6 months

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-02-01
• Completion: 2011-05-01
• First posted: 2010-12-03
• Last updated: 2013-03-15

Locations

1 site across 1 country: China