An Open-labelled Clinical Trial of Live Attenuated Varicella Vaccines to Evaluate the Immunity Persistence After Primary Immunization and Safety and Immunogenicity After the Booster Immunization

Varicella Clinical Trial

Official title:

An Open-labelled Clinical Trial,to Evaluate the Immunity Persistence of the Single-dose Primary Immunization of Live Attenuated Varicella Vaccine on Different Time Points,and the Safety and Immunogenicity After the Booster Immunization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05150392
• Other study ID #: PRO-VZV-3002-1
• Status: Completed
• Phase: Phase 3
• Start date: July 11, 2018
• Est. completion date: August 14, 2020

Study information

• Verified date: November 2021
• Source: Sinovac (Dalian) Vaccine Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-labelled 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 the single-dose primary immunization of live attenuated varicella vaccine on different time points ,and the safety and immunogenicity after the booster immunization

Description:

This study is an open-labelled phase Ⅲ clinical trial.The experimental vaccine manufactured by Sinovac(Dalian) Vaccine Technology Co., Ltd.A total of 1195 subjects who received vaccine in the phase Ⅲ lot-consistency clinical trial were be enrolled .All subjects except C0243 and C0556 were divided into 3 groups according to the order of study number.Subjects in 3 groups received a booster immunization of live attenuated varicella vaccines 1 year,2 years and 3 years after primary immunization,respectively.About 3.0ml of venous blood was collected from each enrolled subject at pre-booster immunization,30 days after booster immunization and the serum was separated for neutralizing antibody detection.The antibody levels were used to evaluate the immunity persistence and immunogenicity after booster immunization of live attenuated varicella vaccines .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1193
• Est. completion date: August 14, 2020
• Est. primary completion date: August 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

• Received one dose live attenuated varicella vaccine in the phase ? lot-consistency clinical trial;

• Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.

Exclusion Criteria:

• Received one dose live attenuated varicella vaccine at the end of the phase ? lot-consistency 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 investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.And the live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection

Locations

Country	Name	City	State
China	Xiangfu County Center for Disease Control and Prevention	Kaifeng	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-seroconversion rate of antibody	seroconversion rates of antibody 1 year after primary immunization	1 year after primary immunization
Primary	Immunogenicity index-seroconversion rate of antibody	seroconversion rates of antibody 2 years after primary immunization	2 years after primary immunization
Primary	Immunogenicity index-seroconversion rate of antibody	seroconversion rates of antibody 3 years after primary immunization	3 years after primary immunization
Primary	Immunogenicity index-Seroconversion rate of antibody	Seroconversion rate of the neutralizing antibody 30 days after booster immunization	30 days after booster immunization
Primary	Immunogenicity index-seropositivity rate of antibody	Seropositivity rate of antibody 30 days after booster immunization	30 days after booster immunization
Secondary	Immunogenicity index-Seropositivity rate of antibody	Seropositivity rate of antibody before booster immunization	Before the booster dose immunization
Secondary	Immunogenicity index-GMT of the antibody	GMT of the antibody before booster immunization	Before the booster dose immunization
Secondary	Immunogenicity index- GMT of the antibody	GMT of the antibody 30 days after booster immunization	30 days after booster immunization
Secondary	Immunogenicity index- GMI of the antibody	GMI of the antibody 30 days after booster immunization	30 days after booster immunization
Secondary	Safety index-Incidence of solicited local or systemic AE	Incidence of solicited local or systemic AE within 14 days after vaccination	within 14 days after vaccination
Secondary	Safety index-Incidence of local or systemic AE	Incidence of local or systemic AE within 30 days after vaccination	within 30 days after vaccination
Secondary	Safety index-Incidence of SAE	Incidence of SAE within 30 days after vaccination	within 30 days after vaccination