NCT01866566

The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination

Phase 4 Study of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: Beijing Center for Disease Control and Prevention · Other Government
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Accepted

Summary

Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management.

Detailed description

Healthy participants aged 1 to 12 years old who had never received Varicella Vaccine are divided into three age groups, 1 to 3 years old group, 4 to 6 years old group and 7-12 years old group. In each age group, participants are randomly divided into experiment group and control groups.

Conditions

• Varicella

Interventions

Type	Name	Description
BIOLOGICAL	HBV-3	Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month
BIOLOGICAL	HBV-6	Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month
BIOLOGICAL	varicella-3	Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month
BIOLOGICAL	varicella-6	Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-01-01
• Completion: 2016-01-01
• First posted: 2013-05-31
• Last updated: 2013-06-26

Locations

1 site across 1 country: China