Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin
- Conditions
- ChickenpoxZoster
- Interventions
- Biological: vaccine without gelatinBiological: vaccine with gelatin
- Registration Number
- NCT01684072
- Lead Sponsor
- Beijing Center for Disease Control and 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vaccine without gelatin vaccine without gelatin use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection vaccine without gelatin vaccine with gelatin use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection vaccine with gelatin vaccine without gelatin use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection vaccine with gelatin vaccine with gelatin use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
- Primary Outcome Measures
Name Time Method To evaluate the immunogenicity of evaluated vaccine 8 months The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.
- Secondary Outcome Measures
Name Time Method To evaluate the safety of live attenuated varicella vaccine 4 months The incidence of adverse events was analyzed statistically.
Trial Locations
- Locations (3)
Chaoyang District Center for Disease Control and Prevention
🇨🇳Beijing, Beijing, China
Jiuyuan Center for Disease Control and Prevention
🇨🇳Baotou, Inner Mongolia, China
Sanhe Center for Disease Control and Prevention
🇨🇳Langfang, Hebei, China