Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine

Phase 4

Completed

• Conditions: Varicella
• Interventions: Biological: varicella-1; Biological: varicella-3; Biological: varicella-5

• Registration Number: NCT02173899
• Lead Sponsor: Changchun Keygen Biological Products Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 716

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
varicella-1	varicella-1	The second varicella vaccine and 1 year of the interval time between 2 doses
varicella-3	varicella-3	The second varicella vaccine and 3 years of the interval time between 2 doses
varicella-5	varicella-5	The second varicella vaccine and 5 years of the interval time between 2 doses

Primary Outcome Measures

Name	Time	Method
Seroconversion rate and GMTs for live attenuated varicella vaccine	35-42 days after the second dose

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse events	within 30 days after the second dose

Trial Locations

Locations (1)

Shenzhen Luohu District Center for Disease Control and Prevention; 🇨🇳 Shenzhen, Guangdong, China