Immunogenicity and Safety Study of 2 Doses of Live Attenuated Varicella Vaccine

NCT01817270 | Completed Phase 4 DMC

• 1 other identifier: NCT02038506
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

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.

Conditions

Chickenpox

Outcome Measures

Primary Outcomes (1)

• Seroconversion rate and GMTs for live attenuated varicella vaccine

  35-42 days after the first and second doses

Secondary Outcomes (1)

• Occurrence of adverse events

  within 30 days after each vaccination

Study Arms (1)

Live Attenuated Varicella Vaccine

EXPERIMENTAL

use the left arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Biological: Live Attenuated Varicella Vaccine

Interventions

Live Attenuated Varicella Vaccine BIOLOGICAL

Live Attenuated Varicella Vaccine

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
• Participant is aged ≥ 1 year to ≤ 3 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℃

You may not qualify if:

• 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 anti-viral 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

Sponsors & Collaborators

• Changchun Keygen Biological Products Co., Ltd.: lead
• Guangdong Provincial Institute of Biological Products And Materia Medica: collaborator

Study Sites (1)

Xinxing Center for Disease Control and Prevention

Yunfu, Guangdong, China

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Huizhen Zheng, Master

  Guangdong Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 25, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

CN (1)