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Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Neonates

NCT02764671 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2016-05-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Guangdong Provincial Institute of Biological Products And Materia Medica

    collaborator OTHER

  • Shenzhen Kangtai Biological Products Co., LTD

    lead INDUSTRY

Principal Investigators

  • Zheng Huizhen, master · Guangdong Center for Disease Prevention and Control

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02764671 on ClinicalTrials.gov