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

NCT06987942 | Completed Phase 4

• 1 other identifier: PRO-VAR-MA4004-JS-2
• Study Type: interventional
• Target: 899
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• GMT of VZV antibody

  GMT of VZV antibody on Day 30 after the vaccination.

  Day 30 after the vaccination

• GMT of HI antibody

  GMT of HI antibody on Day 30 after vaccination.

  Day 30 after vaccination

Secondary Outcomes (6)

• Geometric mean increase (GMI) of VZV antibody

  Day 30 after the vaccination

• Seroconversion rate of VZV antibody

  Day 30 after the vaccination

• Seropositive rate of VZV antibody

  Day 30 after the vaccination

• GMI of HI antibody

  Day 30 after the vaccination

• Seroconversion rate of HI antibody

  Day 30 after the vaccination

Study Arms (3)

Simultaneous vaccination group

EXPERIMENTAL

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

Biological: Varicella vaccine+TIV

Varicella vaccine separate group

ACTIVE COMPARATOR

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

Biological: Varicella vaccine

TIV separate group

ACTIVE COMPARATOR

Participants received a single dose of TIV on Day 0.

Biological: TIV

Interventions

Varicella vaccine+TIV BIOLOGICAL

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

Simultaneous vaccination group

Varicella vaccine BIOLOGICAL

lyophilized powder, subcutaneous

Varicella vaccine separate group

TIV BIOLOGICAL

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

TIV separate group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinovac (Dalian) Vaccine Technology Co., Ltd.: lead

Study Sites (1)

Jiangsu Provincial Center for Disease control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Chickenpox; Influenza, Human

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: September 21, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)