Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
- 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.
- Short title
- Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2022-11-14
- First posted
- 2021-12-15
- Registry last updated
- 2023-12-29
- Primary completion date
- 2022-11-14
- Start date
- 2022-02-13
- Actual participants
- 2,480
- Participants
- 2,480
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Institute Of Biological Products
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05158777
- ClinicalTrials.gov ID
- NCT05158777
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Double masking
- Masked roles
- Participants, Investigators
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.
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.
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.
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.
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.
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
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 13 Years
- Healthy volunteers
- Yes
- 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).
- 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.
- Henan Provincial Center for Disease Prevention and ControlZhenzhou, China
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Chickenpox Primary condition