Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4
NCT ID: NCT04790851
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1133 participants
INTERVENTIONAL
2021-03-10
2021-09-05
Brief Summary
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Experimental Group (384 subjects): 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects): 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects): 1st dose: IIV4 only, 2nd dose: PPV23 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.
Detailed Description
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1152 subjects are divided into 3 groups, including 1 experimental group and 2 control groups (control group A and B). Each group includes 384 subjects respectively.
Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A (384 subjects) will receive: 1st dose: COVAX only, 2nd dose: COVAX only; Control Group B (384 subjects) will receive: 1st dose: IIV4 only, 2nd dose: PPV23 only.
Specifically, each group will be divided again. Each 384-subject group is divided again into 2 age-based subgroups: (1) 18-59 years old; (2) ≥60 years old.
Each subgroup includes 192 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.
To evaluate the immunogenicity, the investigators will detect and compare the neutralizing antibody levels, the seroconversion rates and antibody geometric mean concentrations.
The safety of all groups will be monitored as well.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Experimental group
Experimental Group (384 subjects) will receive: 1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23
COVAX+IIV4; COVAX+PPV23
1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23
Control group A
Control Group A (384 subjects) will receive: 1st dose: COVAX only; 2nd dose: COVAX only
COVAX only (1st and 2nd dose)
1st dose: COVAX only; 2nd dose: COVAX only
Control group B
Control Group B (384 subjects) will receive: 1st dose: IIV4 only; 2nd dose: PPV23 only
IIV4 for the 1st dose and PPV23 for the 2nd dose
1st dose: IIV4 only; 2nd dose: PPV23 only
Interventions
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COVAX+IIV4; COVAX+PPV23
1st dose : combined vaccination of COVAX+IIV4; 2nd dose: combined vaccination of COVAX+PPV23
COVAX only (1st and 2nd dose)
1st dose: COVAX only; 2nd dose: COVAX only
IIV4 for the 1st dose and PPV23 for the 2nd dose
1st dose: IIV4 only; 2nd dose: PPV23 only
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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 any condition that may affect trial assessment as determined by researchers.
18 Years
ALL
Yes
Sponsors
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Chengdu Institute of Biological Products Co.,Ltd.
INDUSTRY
Changchun Institute of Biological Products Co., Ltd.
INDUSTRY
Beijing Institute of Biological Products Co Ltd.
INDUSTRY
Sichuan Center for Disease Control and Prevention
OTHER_GOV
Shanghai Municipal Center for Disease Control and Prevention
OTHER
Centers for Disease Control and Prevention, China
OTHER_GOV
China National Biotec Group Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaodong Sun
Role: PRINCIPAL_INVESTIGATOR
Shanghai Municipal Center for Disease Control and Prevention
Locations
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Sichuan Center for Disease Control and Prevention
Chengdu, , China
Shanghai Municipal Center for Disease Control and Prevention
Shanghai, , China
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, , China
Countries
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References
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Chen H, Huang Z, Chang S, Hu M, Lu Q, Zhang Y, Wang H, Xiao Y, Wang H, Ge Y, Zou Y, Cui F, Han S, Zhang M, Wang S, Zhu X, Zhang B, Li Z, Ren J, Chen X, Ma R, Zhang L, Guo X, Luo L, Sun X, Yang X. Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (Sinopharm BBIBP-CorV) coadministered with quadrivalent split-virion inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in China: A multicentre, non-inferiority, open-label, randomised, controlled, phase 4 trial. Vaccine. 2022 Aug 26;40(36):5322-5332. doi: 10.1016/j.vaccine.2022.07.033. Epub 2022 Jul 29.
Other Identifiers
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COVAX+PPV23+IIV4-Beijing
Identifier Type: -
Identifier Source: org_study_id