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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02965404
Other study ID # PRO-VZV-1001
Secondary ID
Status Completed
Phase Phase 1
First received November 14, 2016
Last updated October 24, 2017
Start date April 2016
Est. completion date August 2016

Study information

Verified date November 2016
Source Sinovac (Dalian) Vaccine Technology Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date August 2016
Est. primary completion date May 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 49 Years
Eligibility 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;

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Investigational live attenuated varicella vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
control live attenuated varicella vaccine
The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)
diluent of lyophilized vaccine
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology

Locations

Country Name City State
China Xiangcheng County Center for Disease Control and Prevention Xuchang Henan

Sponsors (1)

Lead Sponsor Collaborator
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidences of adverse events (AEs) of each group AEs occurred within 30 days after injection will be collected. 30 days
Secondary The incidences of abnormal results of lab tests Cases of abnormal results of laboratory tests will be collected. 30 days
Secondary The incidences of serious adverse events (SAEs) of each group SAEs occurred within 30 days after injection will be collected. 30 days
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