Clinical trial NCT02965404: A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children
Official title: A Blind, Randomized and Controlled Clinical Trial to Evaluate the Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Varicella
Keywords: live attenuated varicella vaccine
safety
adult
adolescent
child
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-16
Enrollment: 270
Sex: ALL
Minimum age (years): 1
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.

Detailed description: This study is a randomized, blind, single-center, controlled phase I clinical trial. The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP), and the negative 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, positive control group, or negative control group in the ratio 1:1:1.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer between 1 - 49 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 infant 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;
* Breast feeding, pregnant, or expected to conceive during the period of this trial;
* 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 of the pre-immune test results of the following indexes of laboratory tests showed clinically significant abnormity:

  1. Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count;
  2. Blood biochemistry detections: alanine transferase (ALT), total bilirubin, blood urea nitrogen (BUN), creatinine;
  3. Urine routine tests: urine protein, urine glucose, urine erythrocyte
* Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

Primary outcomes:
measure: The incidences of adverse events (AEs) of each group
timeFrame: 30 days
Secondary outcomes:
measure: The incidences of abnormal results of lab tests
timeFrame: 30 days
measure: The incidences of serious adverse events (SAEs) of each group
timeFrame: 30 days
Other outcomes:
Locations:
city: Xuchang
country: China
facility: Xiangcheng 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: