An Immunity Persistence Study of Live Attenuated Varicella Vaccine

Официальное название

An Open Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine At 5 and 8 Years After Primary Immunization with Live Attenuated Varicella Vaccine

Обзор

This an open phase Ⅳ clinical trial of live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd .The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 5 and 8 years after primary immunization with live attenuated varicella vaccine.

Подробное описание

This study is an open phase Ⅳ clinical trial in subjects who enrolled in the clinical trial and included in the immunogenicity subgroup PPS set from August to September 2016 .The experimental vaccine and placebo (Freeze Dired Dilution) were manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.A total of 703 subjects will be enrolled including 349 subjects in experimental group and 354 subjects in control group .And 3.0-3.5ml of venous blood was collected from all subjects at 5 and 8 years after primary immunization, and the serum was separated for varicella antibody detection. The window period of blood collection was six months.

Вмешательства

• Биопрепарат Investigational Live Attenuated Varicella Vaccine
  The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. Live attenuated varicella-virus in 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride, sodium dihydrogen phosphate, potassium dihydrogen phosphate per injection.
• Биопрепарат Placebo (Freeze Dired Dilution)
  The placebo (freeze dired dilution) was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. and contained no active ingredient.It was 0·5 mL injection water with sucrose,sodium glutamate,sodium chloride,potassium chloride and phosphate.

Первичные конечные точки

• Immunogenicity index-seropositive rates of varicella antibody [Срок оценки: 5 years after primary immunization]
• Immunogenicity index-GMT of varicella antibody [Срок оценки: 5 years after primary immunization]
• Immunogenicity index-the seropositive rates of varicella antibody [Срок оценки: 8 years after primary immunization]
• Immunogenicity index-the GMT of varicella antibody [Срок оценки: 8 years after primary immunization]

Критерии участия

Критерии включения

• Subjects in PPS immunogenicity subgroup of phase Ⅲ clinical trial of protective effect of varicella vaccine;
• The subject and/or guardian can understand and voluntarily sign the informed consent form;
• Proven legal identity.

Критерии исключения

• History of chickenpox or shingles;
• History of varicella vaccination since phase Ⅲ clinical trial;
• Autoimmune disease or immunodeficiency / immunosuppression;
• History of immunosuppressive therapy since phase Ⅲ clinical trial;
• According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 2 центра

• Xiangcheng County Center for Disease Control and Prevention — Xuchang
• Biyang County Center for Disease Control and Prevention — Zhumadian

Идентификаторы

NCT: NCT05095701 · PRO-VZV-4004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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