A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Immunogenicity and Safety of Combined Immunization of Inactivated SARS-CoV-2 Vaccines (Vero Cell) (COVAX) (Produced in Wuhan) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4)

China National Biotec Group Company Limited3 个研究点分布在 1 个国家目标入组 1,404 人开始时间: 2021年5月6日最近更新: 2021年10月15日

适应症

试验速览

阶段: 4 期
发起方: China National Biotec Group Company Limited
入组人数: 1,404
试验地点: 3
主要终点: Seroconversion rate (IIV4)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Subjects will be recruited and divided into 3 groups:

Experimental Group (468 subjects): 1st dose : combined vaccination of COVAX+PPV23, 2nd dose: combined vaccination of COVAX+IIV4; Control Group A (468 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (468 subjects): 1st dose: PPV23 only, 2nd dose: IIV4 only.

Blood samples will be collected 3 times:

before the 1st dose of vaccinatioin; before the 2nd dose of vaccination; 28 days after the 2nd dose of vaccination.

The immunogenicity and safety of both experimental and control groups will be analyzed.

详细描述

This randomized, parallel, controlled study is designed to evaluate the immunogenicity and safety of simultaneously immunization of COVAX + PPV23 and COVAX + IIV4.

1404 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B). Each group includes 468 subjects respectively.

Experimental Group (468 subjects) will receive: 1st dose : combined vaccination of COVAX+PPV23, 2nd dose: combined vaccination of COVAX+IIV4; Control Group A (468 subjects) will receive: 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (468 subjects) will receive: 1st dose: PPV23 only, 2nd dose: IIV4 only.

Specifically, each group will be divided again. Each 468-subject group is divided again into 2 age-based subgroups: (1) 18-59 years old; (2) ≥60 years old.

Each subgroup includes 234 subjects respectively. Blood samples will be collected 3 times: (1) before the 1st dose of vaccinatioin; (2) before the 2nd dose of vaccination; (3) 28 days after the 2nd dose of vaccination.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Single (Outcomes Assessor)

盲法说明

Serum testing technicians were masked.

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•≥18 years old when enrolled;
•Participants signing the informed consent;
•Being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview;
•Having not been administered any pneumonia vaccine or COVID-19 vaccine, and having not been administered an influenza vaccine in the current season before enrollment;
•≥14 days from the most recent vaccination;
•Before enrollment, the body temperature is ≤37.0C as confirmed by medical history and clinical examination.

排除标准

•Having a history of COVID-19 or a positive nucleic acid test for COVID-19;
•Having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness;
•Being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine;
•Having immunodeficiency disorder, during treatment of malignant tumor, having immunodeficiency induced by immunosuppressants (oral steroid hormones) or HIV, or having a family member with close contact who suffers from congenital immune disorder;
•Having injection of non-specific immunoglobulin within 1 month prior to enrollment;
•Having acute febrile illness or communicable disease;
•Having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection;
•Having severe chronic disease or acute exacerbation of chronic disease, or having uncontrolled hypertension or diabetes;
•Having various infectious, pyogenic, or allergic skin diseases;
•Women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination;
•Having any condition that may affect trial assessment as determined by researchers.
•Exclusion criteria for the second dose:
•Having any serious adverse event related to the first dose vaccination;
•After vaccination, having systemic adverse reaction or allergic reaction with a severity of grade 3 or higher as determined by researchers;
•Having a newly emerging condition that meets the exclusion criteria for the first dose;
•Having any condition that may affect trial assessment as determined by researchers.