Clinical trial NCT01684072: Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin
Official title: Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chickenpox
Zoster
Keywords: varicella vaccine
gelatin
Lead sponsor: Beijing Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
First posted: 2012-09-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the immunogenicity of evaluated vaccine
timeFrame: 8 months
Secondary outcomes:
measure: To evaluate the safety of live attenuated varicella vaccine
timeFrame: 4 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chaoyang District Center for Disease Control and Prevention
state: Beijing
city: Langfang
country: China
facility: Sanhe Center for Disease Control and Prevention
state: Hebei
city: Baotou
country: China
facility: Jiuyuan Center for Disease Control and Prevention
state: Inner Mongolia
Study officials:
affiliation: Beijing Chaoyang District Center for Disease Control and Prevention
name: Nianmin Shi
role: STUDY_CHAIR
References: