An Immunity Persistence Study of Live Attenuated Varicella Vaccine

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05095701
• Other study ID #: PRO-VZV-4004
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: December 18, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: March 2024
• Source: Sinovac (Dalian) Vaccine Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 703
• Est. completion date: July 1, 2024
• Est. primary completion date: December 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

Inclusion Criteria:

• Subjects in PPS immunogenicity subgroup of phase ? 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• 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.
• 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.

Locations

Country	Name	City	State
China	Xiangcheng County Center for Disease Control and Prevention	Xuchang	Henan
China	Biyang County Center for Disease Control and Prevention	Zhumadian	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	Immunogenicity index-seropositive rates of varicella antibody	The seropositive rates of varicella antibody in 5 years after primary immunization with varicella vaccine	5 years after primary immunization
Primary	Immunogenicity index-GMT of varicella antibody	GMT of varicella antibody in 5 years after primary immunization with varicella vaccine	5 years after primary immunization
Primary	Immunogenicity index-the seropositive rates of varicella antibody	The seropositive rates of varicella antibody in 8 years after primary immunization with varicella vaccine	8 years after primary immunization
Primary	Immunogenicity index-the GMT of varicella antibody	GMT of varicella antibody in 8 years after primary immunization with varicella	8 years after primary immunization