Status:
COMPLETED
Evaluation of Immunogenicity and Safety of Combined Immunization of COVID-19 Vaccine (Produced in Beijing) and PPV23 / IIV4
Lead Sponsor:
China National Biotec Group Company Limited
Collaborating Sponsors:
Chengdu Institute of Biological Products Co.,Ltd.
Changchun Institute of Biological Products Co., Ltd.
Conditions:
Influenza, Human
Pneumonia, Pneumococcal
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Subjects will be recruited and divided into 3 groups: Experimental Group (384 subjects): 1st dose : combined vaccination of COVAX+IIV4, 2nd dose: combined vaccination of COVAX+PPV23; Control Group A ...
Detailed Description
This randomized, parallel, controlled study is designed to evaluate the immunogenicity and safety of simultaneously immunization of COVAX + PPV23 and COVAX + IIV4. 1152 subjects are divided into 3 gr...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- ≥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.
- Exclusion criteria for the first dose:
- 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.
Exclusion
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2021
Estimated Enrollment :
1133 Patients enrolled
Trial Details
Trial ID
NCT04790851
Start Date
March 10 2021
End Date
September 5 2021
Last Update
October 20 2021
Active Locations (3)
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1
Sichuan Center for Disease Control and Prevention
Chengdu, China, 610041
2
Shanghai Municipal Center for Disease Control and Prevention
Shanghai, China, 200336
3
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, China, 030012