Jiangsu Provincial Center for Disease control and Prevention
Nanjing, Jiangsu, 210009, China
NCT Number: NCT06987942
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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Notify Me7 year–12 year
All sexes
Interventional
Phase 4
Nanjing, Jiangsu, 210009, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
lyophilized powder, subcutaneous
Inactived, split virion, containing H1N1, H3N2 and BV strains.
Time frame: Day 30 after the vaccination
GMT of VZV antibody on Day 30 after the vaccination.
Time frame: Day 30 after vaccination
GMT of HI antibody on Day 30 after vaccination.
Time frame: Day 30 after the vaccination
GMI of VZV antibody on Day 30 after the vaccination.
Time frame: Day 30 after the vaccination
Seroconversion rate of VZV antibody on Day 30 after the vaccination.
Time frame: Day 30 after the vaccination
Seropositive rate of VZV antibody on Day 30 after the vaccination.
Time frame: Day 30 after the vaccination
GMI of HI antibody on Day 30 after the vaccination.
Time frame: Day 30 after the vaccination
Seroconversion rate of HI antibody on Day 30 after the vaccination.
Time frame: Day 30 after the vaccination
Seroprotection rate of HI antibody on Day 30 after the vaccination.
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Industry
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
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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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