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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

Sponsor
Sinovac (Dalian) Vaccine Technology Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05150392
Collaborator
(none)
1,193
Enrollment
1
Location
3
Arms
25.1
Actual Duration (Months)
47.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Biological: Investigational live attenuated varicella vaccine
 Phase 3

Detailed 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 .

Study Design

Study Type:
Interventional
Actual Enrollment :
1193 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jul 11, 2018
Actual Primary Completion Date :
Aug 11, 2018
Actual Study Completion Date :
Aug 14, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Booster immunization 1 year after primary immunization

Subjects C0001-C0400 except C0243 received 1 dose of booster immunization 1 year after primary immunization.

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
Experimental: Booster immunization 2 year after primary immunization

Subjects C0401-C0800 except C0556 received 1 dose of booster immunization 2 years after primary immunization.

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
Experimental: Booster immunization 3 year after primary immunization

Subjects C0801-C1197 received 1 dose of booster immunization 3 years after primary immunization.

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

Outcome Measures

Primary Outcome Measures

  1. Immunogenicity index-seroconversion rate of antibody [1 year after primary immunization]

    seroconversion rates of antibody 1 year after primary immunization

  2. Immunogenicity index-seroconversion rate of antibody [2 years after primary immunization]

    seroconversion rates of antibody 2 years after primary immunization

  3. Immunogenicity index-seroconversion rate of antibody [3 years after primary immunization]

    seroconversion rates of antibody 3 years after primary immunization

  4. Immunogenicity index-Seroconversion rate of antibody [30 days after booster immunization]

    Seroconversion rate of the neutralizing antibody 30 days after booster immunization

  5. Immunogenicity index-seropositivity rate of antibody [30 days after booster immunization]

    Seropositivity rate of antibody 30 days after booster immunization

Secondary Outcome Measures

  1. Immunogenicity index-Seropositivity rate of antibody [Before the booster dose immunization]

    Seropositivity rate of antibody before booster immunization

  2. Immunogenicity index-GMT of the antibody [Before the booster dose immunization]

    GMT of the antibody before booster immunization

  3. Immunogenicity index- GMT of the antibody [30 days after booster immunization]

    GMT of the antibody 30 days after booster immunization

  4. Immunogenicity index- GMI of the antibody [30 days after booster immunization]

    GMI of the antibody 30 days after booster immunization

  5. Safety index-Incidence of solicited local or systemic AE [within 14 days after vaccination]

    Incidence of solicited local or systemic AE within 14 days after vaccination

  6. Safety index-Incidence of local or systemic AE [within 30 days after vaccination]

    Incidence of local or systemic AE within 30 days after vaccination

  7. Safety index-Incidence of SAE [within 30 days after vaccination]

    Incidence of SAE within 30 days after vaccination

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Received one dose live attenuated varicella vaccine in the phase Ⅲ 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 Ⅲ 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xiangfu County Center for Disease Control and Prevention Kaifeng Henan China 461700

Sponsors and Collaborators

  • Sinovac (Dalian) Vaccine Technology Co., Ltd.

Investigators

  • Principal Investigator: Shengli Xia, Master, Henan Provincial Center for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sinovac (Dalian) Vaccine Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05150392
Other Study ID Numbers:
  • PRO-VZV-3002-1
First Posted:
Dec 9, 2021
Last Update Posted:
Dec 9, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Chickenpox
Herpes Zoster

Study Results

No Results Posted as of Dec 9, 2021