NCT02764671

Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

The Safety and Immunogenicity of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5,000 (estimated)
• Sponsor: Shenzhen Kangtai Biological Products Co., LTD · Industry
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Accepted

Summary

The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.

Conditions

• Hepatitis
• Hepatitis B
• Liver Diseases
• Digestive System Diseases

Interventions

Type	Name	Description
BIOLOGICAL	10μg/0.5ml recombinant hepatitis B vaccine	5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.

Timeline

• Start date: 2015-05-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2016-05-06
• Last updated: 2016-05-06

Locations

2 sites across 1 country: China