Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173899
• Other study ID #: NCT02079605
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2014
• Last updated: August 28, 2014
• Start date: June 2014
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Changchun Keygen Biological Products Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• varicella-1
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
• varicella-3
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
• varicella-5
Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day

Locations

Country	Name	City	State
China	Shenzhen Luohu District Center for Disease Control and Prevention	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Changchun Keygen Biological Products Co., Ltd.	Guangdong Provincial Institute of Biological Products And Materia Medica

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate and GMTs for live attenuated varicella vaccine		35-42 days after the second dose
Secondary	Occurrence of adverse events		within 30 days after the second dose