Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin

Beijing Center for Disease Prevention and Control

Status and phase: Completed; Phase 4

Conditions: Chickenpox; Zoster

Treatments: Biological: vaccine with gelatin; Biological: vaccine without gelatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01684072

BJCDPC-2

Details and patient eligibility

About

The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.

Full description

Observational Objectives:

To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.

To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.

Enrollment: 1,200 patients

Sex: All

Ages: 1 to 12 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 considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
• Participant is aged ≥ 1 year to ≤ 12 years
• Body temperature ≤ 37.0℃
• Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster

Exclusion criteria

• Known allergy to any constituent of the vaccine
• Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
• Known bleeding disorder
• Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
• Participation in any other interventional clinical trial
• An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial
• Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
• Reported clearly the infection of the upper respiratory tract with 6 months
• Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
• 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: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,200 participants in 2 patient groups

vaccine without gelatin

Experimental group

Description:

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

Treatment:

Biological: vaccine with gelatin

Biological: vaccine without gelatin

vaccine with gelatin

Active Comparator group

Description:

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

Treatment:

Biological: vaccine with gelatin

Biological: vaccine without gelatin