NCT06987942

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 899 (actual)
• Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd. · Industry
• Sex: All
• Age: 7 Years – 12 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-09-21
• Primary completion: 2024-11-15
• Completion: 2024-11-15
• First posted: 2025-05-23
• Last updated: 2025-05-23

Locations

1 site across 1 country: China