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

Launched by SINOVAC (DALIAN) VACCINE TECHNOLOGY CO., LTD. · Aug 16, 2021

Keywords

ClinConnect Summary

This study tests the safety and immune response of a live attenuated varicella (chickenpox) vaccine made by Sinovac in people aged 13 years and older. It is a large, Phase 3, randomized and double-blind trial, meaning people are assigned by chance to receive the Sinovac vaccine, a comparison vaccine, or a placebo, and neither the participants nor the study staff know which one is given. The main goal is to see how well the vaccine helps the body make antibodies by about 28 days after completing the two-dose schedule, with the 0,28; 0,42; or 0,56 day timing options. Some participants will also be tested with a 0,70 day schedule to compare timing. Safety is also a key part, with monitoring for side effects after each dose and for serious health problems for several months.

Who can take part and what to expect: healthy teens and adults 13 years and older who have not had chickenpox or shingles can be eligible. There are several exclusion rules, such as pregnancy, immune system problems, or a history of serious vaccine reactions. About 2,400 people will join, with roughly equal numbers of 13–17 year-olds and adults 18 and older. Participants will be randomly assigned to receive the experimental vaccine, a control vaccine, or a placebo in some groups, with different dosing schedules. After each vaccination, you’ll be watched for side effects for about the first 28 days (and 14 days for some checks), and serious adverse events will be tracked for up to six months after the second dose. There are also planned blood tests to see how long the vaccine’s protection lasts, with follow-up testing planned for several years.

Gender

ALL

Eligibility criteria

• 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:
• • History of chickenpox or shingles;
• • 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 asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
• • 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)and diabetes that cannot be controlled by drugs, liver or kidney diseases;
• • Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) 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 3 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.