Simultaneous Administration Study of Varicella Attenuated Live Vaccine and Trivalent Inactivated Influenza Vaccine (Split Virion)

NCT ID: NCT06987942

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 899 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-21
• Study Completion Date: 2024-11-15

Brief Summary

The goal of this clinical trial is to evaluate the immunogenicity of simultaneous administration of varicella live attenuated vaccine (varicella vaccine hereafter) and trivalent inactivated influenza vaccine (TIV hereafter). It will also evaluate the safety of simultaneous administration of the two vaccines. The main questions it aims to answer are:

• If geometric mean titer (GMT) of varicella zoster vrius (VZV) antibody in the simultaneous administration group is non-inferior to that in the varicella vaccine separate group.
• If GMT of hemagglutination inhibition (HI hereafter) antibody in the simultaneous administration group is non-inferior to that in the TIV separate group.

Participants in the simultaneous administration group received a single dose of varicella vaccine and TIV simultaneously on day 0. Participants in the separate groups received a single dose of varicella vaccine or TIV on day 0, respectively.

Conditions

Varicella; Influenza Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Simultaneous vaccination group

Participants received a single dose of varicella vaccine and TIV on Day 0.

Group Type: EXPERIMENTAL

Varicella vaccine+TIV

Intervention Type: BIOLOGICAL

• Varicella vaccine: lyophilized powder, subcutaneous injection
• TIV: Inactived, split virion, containing H1N1, H3N2 and BV strains.

Varicella vaccine separate group

Participants received a single dose of varicella vaccine on Day 0.

Group Type: ACTIVE_COMPARATOR

Varicella vaccine

Intervention Type: BIOLOGICAL

lyophilized powder, subcutaneous

TIV separate group

Participants received a single dose of TIV on Day 0.

Group Type: ACTIVE_COMPARATOR

TIV

Intervention Type: BIOLOGICAL

Inactived, split virion, containing H1N1, H3N2 and BV strains.

Interventions

Varicella vaccine+TIV

• Varicella vaccine: lyophilized powder, subcutaneous injection
• TIV: Inactived, split virion, containing H1N1, H3N2 and BV strains.

Intervention Type: BIOLOGICAL

Varicella vaccine

lyophilized powder, subcutaneous

Intervention Type: BIOLOGICAL

TIV

Inactived, split virion, containing H1N1, H3N2 and BV strains.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy children aged 7-12 years;
• 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

• Vaccination history of varicella vaccine;
• Had received a single dose of influenza vaccine for 2024-2025 season;
• 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac (Dalian) Vaccine Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Provincial Center for Disease control and Prevention

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

PRO-VAR-MA4004-JS-2

Identifier Type: -

Identifier Source: org_study_id