> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/safety-and-immunogenicity-of-live-attenuated-varicella-5626ae6a-d84a-4e82-81ab-f185564102ec
> Record changed: 2026-10-13

# Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old

NCT05158777

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

Participants

2,480

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

Lead sponsor

Shanghai Institute Of Biological Products

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

Start date

2022-02-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

## Title and summary

**Summary**

This is a randomized, blind, controlled clinical trial of live attenuated varicella vaccines manufactured by Shanghai Institute of Biological Products Co.,Ltd. The purpose of this study is to evaluate the immunogenicity and safety of a two doses vaccination of investigational vaccine with 0,28 day and 0,56 day immunization schedule in population aged ≥13 years old.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Short title**

Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Official title**

A Randomized, Blind, Controlled Clinical Trial to Evaluate Safety and Immunogenicity of Live Attenuated Varicella Vaccine After a Two-dose Vaccination Course in Healthy Population Aged ≥13 Years Old

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

## Dates

**Completion date**

2022-11-14

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**First posted**

2021-12-15

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Registry last updated**

2023-12-29

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Primary completion date**

2022-11-14

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Start date**

2022-02-13

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

## Size and sites

**Actual participants**

2,480

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Participants**

2,480

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Protocol amendments**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Randomisation ratio**

1:1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Lead sponsor**

Shanghai Institute Of Biological Products

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

## Identifiers

**Registry ID**

NCT05158777

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**ClinicalTrials.gov ID**

NCT05158777

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Double masking

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

## Outcomes

### Primary outcomes

1. Seroconversion rate of HI antibody  
Timeframe: Day 42 after the whole schedule  
The seroconversion rate of the antibody 42 days among all subjects after the second vaccination.
2. GMT of HI antibody  
Timeframe: Day 42 after the whole schedule  
The GMT of the antibody 42 days among all subjects after the second vaccination.

### Secondary outcomes

1. Seroprotection rate of HI antibody  
Timeframe: Day 42 after the whole schedule  
The seroprotection rate of the antibody 42 days among all subjects after the second vaccination.
2. Incidence of adverse reactions within 30 minutes after each dose  
Timeframe: Within 30 minutes after each dose  
Incidence of adverse reactions within 30 minutes after each dose vaccination with immunization course of 0,28 days and 0,56 days.
3. Incidence of adverse reactions within 0\~28 days after each dose  
Timeframe: Within 0\~28 days after each dose  
Incidence of adverse reactions within 0\\\~28 days after each dose vaccination with immunization course of 0,28 days and 0,56 days.
4. Incidence of serious adverse events  
Timeframe: From vaccination to 6 months after the second vaccination  
Incidence of serious adverse events from vaccination to 6 months after the second vaccination with immunization course of 0,28 days and 0,56 days

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

## Eligibility

**Sex**

All

**Age groups**

Children, Adults, Older adults

**Minimum age**

13 Years

**Healthy volunteers**

Yes

### Inclusion criteria

- Healthy population aged 13 years and above;
- Proven legal identity;
- The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 13-17 years, both subjects and guardians need to sign the informed consent form).

### Exclusion criteria

- Disease history or vaccine history of chickenpox or shingles;
- Have fever before vaccination, axillary temperature >37.0°C;
- Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 6 months;
- History of severe allergy and asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and abdominal pain;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Autoimmune disease or immunodeficiency / immunosuppression;
- Severe chronic diseases, severe cardiovascular diseases, hypertension (adult field measurement: SBP ≥140mmHg or diastolic blood pressure ≥90mmHg) that could not be controlled by drugs, diabetes, liver and kidney diseases, malignant tumors, etc.;
- Family history of psychosis,severe neurological disease (epilepsy, convulsions or twitching) or mental illness;
- Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia or splenectomy resulting from any condition;
- Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- History of alcohol or drug abuse;
- Receipt of blood products within in the past 6 months;
- Participating in other drug/vaccine clinical trial;
- Receipt of attenuated live vaccines in the past 28 days;
- Receipt of inactivated or subunit vaccines in the past 7 days;
- Onset of various acute or chronic diseases within 7 days prior to the study;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

## Sites

- Henan Provincial Center for Disease Prevention and ControlZhenzhou, China

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05158777)

## Related records

### Drugs (1)

- [Mumps virus vaccine live](https://trialight.com/data/asset/mumps-virus-vaccine-live-8fede166-363c-431a-9225-3794f1579a22.md)

### Lead sponsors (1)

- [Shanghai Institute Of Biological Products](https://trialight.com/data/company/shanghai-institute-of-biological-products-47ce571f-b25c-4e8a-a146-48b2b23c0b2a.md)

### Conditions (1)

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

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