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Completed

NCT Number: NCT06987942

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

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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jiangsu Provincial Center for Disease control and Prevention

Nanjing, Jiangsu, 210009, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Varicella vaccine+TIV

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

Varicella vaccine

Biological

lyophilized powder, subcutaneous

TIV

Biological

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

Primary outcomes

  1. GMT of VZV antibody

    Time frame: Day 30 after the vaccination

    GMT of VZV antibody on Day 30 after the vaccination.

  2. GMT of HI antibody

    Time frame: Day 30 after vaccination

    GMT of HI antibody on Day 30 after vaccination.

Secondary outcomes

  1. Geometric mean increase (GMI) of VZV antibody

    Time frame: Day 30 after the vaccination

    GMI of VZV antibody on Day 30 after the vaccination.

  2. Seroconversion rate of VZV antibody

    Time frame: Day 30 after the vaccination

    Seroconversion rate of VZV antibody on Day 30 after the vaccination.

  3. Seropositive rate of VZV antibody

    Time frame: Day 30 after the vaccination

    Seropositive rate of VZV antibody on Day 30 after the vaccination.

  4. GMI of HI antibody

    Time frame: Day 30 after the vaccination

    GMI of HI antibody on Day 30 after the vaccination.

  5. Seroconversion rate of HI antibody

    Time frame: Day 30 after the vaccination

    Seroconversion rate of HI antibody on Day 30 after the vaccination.

  6. Seroprotection rate of HI antibody

    Time frame: Day 30 after the vaccination

    Seroprotection rate of HI antibody on Day 30 after the vaccination.

Sponsors and collaborators

Lead sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Controlled, Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Administered Concomitantly With Trivalent Inactivated Influenza Vaccine (Split Virion) in Children Aged 7-12 Years

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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