Study on Booster Immunization With Varicella Vaccine at Different Intervals

Sinovac

Status and phase: Completed; Phase 4

Conditions: VZV; Varicella Immunisation

Treatments: Biological: Varicella vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06994052

PRO-VAR-MA4004-JS-1

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the immunogenicity and safety of booster immunization of varicella live attenuated vaccine (varicella vaccine hereafter) at different intervals.

Enrollment: 412 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children aged 7-12 years;
• Has previously received a single dose of varicella vaccine, with at least 3 months since the first dose;
• The subject or legal guardian can understand and sign the informed consent form (double signature is required for those over 8 years old);
• Participants and their legal guardians voluntarily participate in the study and are able to comply with all study procedures;
• Provide legal identity proof;

Exclusion criteria

• History of varicella;
• History of severe allergic reactions to vaccines (such as acute anaphylaxis, angioedema, dyspnea, etc.);
• Suffering from acute disease, severe chronic disease, acute exacerbation of chronic disease;
• With any confirmed or suspected immunodeficiency disease, immunocompromised or receiving immunosuppressive therapy (including systemic steroid therapy);
• With a history of congenital immune diseases or close contact with family members with a history of congenital immune diseases;
• With encephalopathy, uncontrolled epilepsy, other progressive neurological disorders, history of Guillain-Barre syndrome;
• Body temperature >37℃ at the time of vaccination;
• Receipt of blood products within 3 months before receiving investigational vaccine;
• Receipt of another study drug within 30 days before receipt of the investigational vaccine;
• Receipt of live attenuated vaccine within 28 days before receipt of investigational vaccine;
• Receipt of subunit or inactivated vaccine within 7 days before receipt of investigational vaccine;
• Participated in other clinical trials before enrollment and were enrolled in another clinical trial during the follow-up period or planned to participate in another clinical trial within 3 months;
• The participant had any other factors that were ineligible for vaccination by in the investigator's judgment.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

412 participants in 4 patient groups

Group A

Experimental group

Description:

Participants received a single dose of varicella vaccine as booster immunization 3 months after their primary vaccination.

Treatment:

Biological: Varicella vaccine

Group B

Experimental group

Description:

Participants received a single dose of varicella vaccine as booster immunization 18-30 months after their primary vaccination.

Treatment:

Biological: Varicella vaccine

Group C

Experimental group

Description:

Participants received a single dose of varicella vaccine as booster immunization 36-48 months after their primary vaccination.

Treatment:

Biological: Varicella vaccine

Group D

Experimental group

Description:

Participants received a single dose of varicella vaccine as booster immunization 60-72 months after their primary vaccination.

Treatment:

Biological: Varicella vaccine