Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine

A Study to Evaluate the Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine

The purpose of this study is to observe the occurrence of adverse events, seroconversion rate and geometric mean titres(GMTs) of 2 doses of live attenuated varicella vaccine.

Study Overview

• Status: Completed
• Conditions: Varicella
• Intervention / Treatment: Biological: varicella-1; Biological: varicella-3; Biological: varicella-5

• Study Type: Interventional
• Enrollment (Actual): 716
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China
      • Shenzhen Luohu District Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
• Participant is aged ≥ 1 year to ≤ 7 years
• Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
• Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
• Body temperature ≤ 37.5℃

Exclusion Criteria:

• Known allergy to any constituent of the vaccine
• Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
• Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
• Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
• Failed to the Expanded Programme on Immunization(EPI)
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination
• Plan to receive any vaccine in the 4 weeks following the trial vaccination
• Known bleeding disorder
• Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination
• Reported the history of acute illness had need systemic antibiotics or antiviral treatment of infections in the 7 days preceding the trial vaccination
• An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
• Participation in any other interventional clinical trial
• Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: varicella-1; The second varicella vaccine and 1 year of the interval time between 2 doses	Biological: varicella-1; Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
Experimental: varicella-3; The second varicella vaccine and 3 years of the interval time between 2 doses	Biological: varicella-3; Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
Experimental: varicella-5; The second varicella vaccine and 5 years of the interval time between 2 doses	Biological: varicella-5; Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Seroconversion rate and GMTs for live attenuated varicella vaccine	35-42 days after the second dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events	within 30 days after the second dose

Collaborators and Investigators

• Sponsor: Changchun Keygen Biological Products Co., Ltd.
• Collaborators: Guangdong Provincial Institute of Biological Products And Materia Medica
• Investigators: Principal Investigator: Huizhen Zheng, Master, Guangdong Center for Disease Prevention and Control

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 25, 2014

Study Record Updates

• Last Update Posted (Estimate): September 1, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Chickenpox
• Other Study ID Numbers: NCT02079605