drugset / Trial / NCT06987942

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

NCT06987942

Phase 4 Completed 899 enrolled Sinovac (Dalian) Vaccine Technology Co., Ltd.
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Varicella vaccine Vaccine Subcutaneous
Comparator trivalent inactivated influenza vaccine Vaccine

Indications