Clinical trial NCT02981836: A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines
Official title: A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Keywords: live attenuated varicella vaccine
protective effect
safety
immunogenicity
child
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 5997
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 evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.

Detailed description: This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group or control group in the ratio 1:1.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer between 1 - 12 years old;
* Proven legal identity;
* Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the volunteer being included into this study;

Exclusion Criteria:

* Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection;
* Axillaty temperature \> 37.0 °C;
* History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
* History of epilepsy, seizures or convulsions, or a family history of mental illness, autoimmune disease or immunodeficiency;
* Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Receipt of any of the following products:

  1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
  2. Any live attenuated vaccine within 1 month prior to study entry;
  3. Any blood product, immunosuppressant, hormone, or other investigational medicine(s) within 30 days prior to study entry;
* Any significant abnormity of heart, lung, skin, or pharynx;
* Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

Primary outcomes:
measure: The incidences of varicella of each group
timeFrame: ≥30 cases reported 30 days after injection
measure: The protection rate of the vaccine
timeFrame: ≥30 cases reported after 30 days of the injection
Secondary outcomes:
measure: The incidences of adverse events (AEs) of each group
timeFrame: 30 days
measure: The incidences of serious adverse events (SAEs) of each group
timeFrame: 6 months
measure: The seroconversion rate of the immunogenicity group
timeFrame: 30 days after injection
measure: The geometric mean titer (GMT) of the immunogenicity group
timeFrame: 30 days
measure: The geometric mean fold increase (GMI) of the immunogenicity group
timeFrame: 30 days after injection
Other outcomes:
Locations:
city: Xuchang
country: China
facility: Xiangcheng County Center for Disease Control and Prevention
state: Henan
city: Zhumadian
country: China
facility: Biyang County Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Provincial Center for Disease Control and Prevention
name: Shengli Xia
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Y, Wang L, Wang Y, Zhang W, Jia N, Xie Z, Huang L, You W, Lu W, Li E, Gao F, Hu Y, Meng F, Xia S. Immunogenicity and Safety of a Booster Dose of Live Attenuated Varicella Vaccine, and Immune Persistence of a Primary Dose for Children Aged 2 to 6 Years. Vaccines (Basel). 2022 Apr 22;10(5):660. doi: 10.3390/vaccines10050660.
citation: Hao B, Chen Z, Zeng G, Huang L, Luan C, Xie Z, Chen J, Bao M, Tian X, Xu B, Wang Y, Wu J, Xia S, Yuan L, Huang J. Efficacy, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: double-blind, randomized, placebo-controlled clinical trial. Clin Microbiol Infect. 2019 Aug;25(8):1026-1031. doi: 10.1016/j.cmi.2018.12.033. Epub 2019 Jan 4.