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> Record changed: 2026-10-13

# A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine

NCT05669625

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

Recruitment status

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

Participants

12,440

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

Lead sponsor

China National Biotec Group Company Limited

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

Start date

2022-12-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

Number of sites

13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

## Title and summary

**Summary**

The goal of this clinical trial is to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Short title**

A Phase III Clinical Trial to Evaluate the Efficacy and Safety of the Live Attenuated Varicella Vaccine

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Official title**

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Live Attenuated Varicella Vaccine in Healthy People

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Recruitment status**

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

## Dates

**Completion date**

2026-09-14

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**First posted**

2023-01-03

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Registry last updated**

2023-06-18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Primary completion date**

2024-04-14

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Start date**

2022-12-26

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

## Size and sites

**Actual participants**

12,440

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Participants**

12,440

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Randomisation ratio**

1:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Number of sites**

13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Lead sponsor**

China National Biotec Group Company Limited

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

## Identifiers

**Registry ID**

NCT05669625

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**ClinicalTrials.gov ID**

NCT05669625

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Triple masking

**Masked roles**

Participants, Investigators, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

## Outcomes

### Primary outcomes

1. The incidences of varicella in each group  
Timeframe: number of cases reported 30 days after vaccination  
The first 24 cases of varicella occurred 30 days after injection will be collected
2. The efficacy of the live attenuated varicella vaccine  
Timeframe: number of cases reported 30 days after vaccination  
The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination

### Secondary outcomes

1. The vaccine efficacy against laboratory-confirmed cases of moderate and severe varicella  
Timeframe: number of cases reported 30 days after vaccination  
The vaccine efficacy will be calculated based on the reported cases occurred 30 days after vaccination
2. The vaccine efficacy against clinical-confirmed cases  
Timeframe: number of cases reported 30 days after vaccination  
calculated based on the reported cases occurred 30 days after vaccination
3. The incidences of adverse events (AEs)  
Timeframe: within 30 days after vaccination  
AEs occurred within 30 days after injection will be collected
4. The incidences of serious adverse events (SAEs)  
Timeframe: at least 6 months after vaccination  
SAEs occurred within 6 months after vaccination will be collected
5. The geometric mean titer (GMT) in the immunogenicity subgroup  
Timeframe: 30 days after vaccination  
Geometric mean titer (GMT) will be measured before and 30 days after vaccination
6. The seroconversion rate of the immunogenicity subgroup  
Timeframe: 30 days after vaccination  
The seroconversion rate will be calculated before and 30 days after vaccination
7. The geometric mean fold increase (GMI) of the immunogenicity subgroup  
Timeframe: 30 days after vaccination  
Geometric mean fold increase (GMI) of the immunogenicity group will be calculated based on the geometric mean titer
8. The immune persistence of the immunogenicity subgroup  
Timeframe: 1 year, 2 years, and 3 years after vaccination  
Geometric mean titer (GMT) will be measured

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

## Eligibility

**Sex**

All

**Age groups**

Children, Adults

**Minimum age**

1 Year

**Maximum age**

59 Years

**Healthy volunteers**

Yes

### Inclusion criteria

- Healthy volunteer between 13 - 59 years old for Stage 1, 1-12 years old for Stage 2, and be able to provide legal identification ;
- Subject and/or guardian has the ability to understand study requirements and processes, consent to participate in clinical trials, and sign informed consent forms;
- Consent to use effective contraception during study participation, no pregnancy and no family planning (for women of childbearing potential or their spouses);
- Axillary temperature ≤ 37.0 °C on the day of enrollment;

### Exclusion criteria

- Has received any varicella vaccine before ( Not applicable to Stage 1）;
- Has history of varicella or herpes zoster infection, or contact with varicella/shingles patients or suspected varicella/shingles patients within 30 days before enrollment ( Not applicable to Stage 1）;
- Currently using salicylates (including salicylic acid, aspirin, diflunisalin, p-aminosalicylate (sodium), dicalicylate, benoxate, etc.), or plan to use it for a long time during the study；
- Have had febrile illness (axillary temperature ≥ 38.5 °C) or used antipyretic, analgesic, anti-allergic drugs (such as acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) 3 days before vaccination；
- Have a history of allergy to vaccine components and excipients or severe drug allergy, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, local allergic necrosis (Arthus) reaction, severe urticaria, etc；
- Have a history of epilepsy, convulsions or convulsions, and have a family history of severe neurological disease or psychosis
- Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases；
- With severe congenital malformations, hereditary diseases, serious cardiovascular diseases, serious liver/kidney diseases, complicated diabetes, malignant tumors, and severe malnutrition
- Immunosuppressant therapy, such as long-term oral or injectable glucocorticoid therapy (≥ 14 days, dose ≥2 mg/kg/day or ≥20 mg/day or equivalent to prednisone), within 3 months prior to enrollment or planned within 30 days of vaccination, but topical medications (e.g., ointments, eye drops, inhalers, or nasal sprays) are not restricted
- Have received blood/blood-related products or immunoglobulins 3 months prior to vaccination, or plan to use such products 30 days after vaccination；
- Have received a live attenuated vaccine within 30 days prior to the trial vaccine, or any vaccine within 14 days prior to vaccination;
- Asplenectomy or splenectomy due to any condition (e.g. splenectomy);
- Those with a history of thrombocytopenia or other coagulation disorders, which may cause contraindications to subcutaneous injection;
- Suffering from various infectious, purulent or allergic skin diseases;
- Are participating in other investigational or unregistered clinical trials of products (drugs, vaccines or devices, etc.), or have plans to participate in other clinical trials before the end of this clinical trial;
- Has any other factors that are not suitable for participation in the clinical trial in the judgment of the investigator

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

## Sites

- Sinan County Center for Disease Control and PreventionTongren, China
- Songtao Miao Autonomous County Center for Disease Control and PreventionTongren, China
- Yuping Dong Autonomous County Center for Disease Control and PreventionTongren, China
- Qi County Center for Disease Control and PreventionHebi, China
- Wuzhi County Center for Disease Control and PreventionJiaozuo, China
- Wuyang County Center for Disease Control and PreventionLuohe, China
- Pei County Center for Disease Control and PreventionXuzhou, China
- Huaiyin District Center for Disease Control and PreventionXuzhou, China
- Mianyang Anzhou District Center for Disease Control and PreventionMianyang, China
- Southern County Center for Disease Control and PreventionNanchong, China
- Neijiang City Center for Disease Control and PreventionNeijiang, China
- Lancang Lahu Autonomous County Center for Disease Control and PreventionPu'er, China
- Yanshan County Center for Disease Control and PreventionWenshan, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05669625)

## Related records

### Drugs (1)

- [Canakinumab](https://trialight.com/data/asset/canakinumab-7cd74b21-082d-4a09-8847-aa6d401bc853.md)

### Collaborators (2)

- Beijing Institute of Biological Products Co Ltd.
- Jiangsu Province Centers for Disease Control and Prevention

### Lead sponsors (1)

- [China National Biotec Group Company Limited](https://trialight.com/data/company/china-national-biotec-group-company-limited-e14db185-d2b3-4b40-8f44-7e119dd3c717.md)

### Conditions (1)

- [Chickenpox](https://trialight.com/data/condition/chickenpox-4213f806-c779-5b01-9e52-7179e9edebeb.md) Primary condition

### Targets (1)

- [IL1B](https://trialight.com/data/target/il1b-a893351e-84c8-5959-8b42-db764a8a634f.md)

---

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