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

NCT06987942 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 899

Last updated 2025-05-23

No results posted yet for this study

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

Interventions

BIOLOGICAL

Varicella vaccine+TIV

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

BIOLOGICAL

Varicella vaccine

lyophilized powder, subcutaneous

BIOLOGICAL

TIV

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

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-21
Primary Completion
2024-11-15
Completion
2024-11-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06987942 on ClinicalTrials.gov