Trials / Enrolling By Invitation
Enrolling By InvitationNCT05095701
An Immunity Persistence Study of Live Attenuated Varicella Vaccine
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
- Status
- Enrolling By Invitation
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 703 (estimated)
- Sponsor
- Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 1 Year – 17 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BIOLOGICAL | 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. |
Timeline
- Start date
- 2021-12-18
- Primary completion
- 2021-12-19
- Completion
- 2025-10-01
- First posted
- 2021-10-27
- Last updated
- 2025-01-27
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05095701. Inclusion in this directory is not an endorsement.