Immunogenicity and Safety of 2 Doses of Live Attenuated Varicella Vaccine

Changchun Keygen Biological Products

Status and phase: Completed; Phase 4

Conditions: Varicella

Treatments: Biological: varicella-5; Biological: varicella-3; Biological: varicella-1

Study type: Interventional

Funder types: Other

Identifiers

NCT02173899

NCT02079605

Details and patient eligibility

About

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.

Enrollment: 716 patients

Sex: All

Ages: 1 to 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

716 participants in 3 patient groups

varicella-1

Experimental group

Description:

The second varicella vaccine and 1 year of the interval time between 2 doses

Treatment:

Biological: varicella-1

varicella-3

Experimental group

Description:

The second varicella vaccine and 3 years of the interval time between 2 doses

Treatment:

Biological: varicella-3

varicella-5

Experimental group

Description:

The second varicella vaccine and 5 years of the interval time between 2 doses

Treatment:

Biological: varicella-5