Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23

Study Overview
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Brief Summary
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The main objective of this study was to evaluate the immunogenicity and safety of the booster dose of COVID-19 inactivated vaccine and co-immunization with quadrivalent influenza vaccine and 23-valent pneumonia polysaccharide vaccine in people aged 18 years and older. A randomized controlled, open trial design was adopted. The study was conducted with informed consent of the subjects for immunogenicity and safety in the population aged 18 years and older. A total of 3000 healthy subjects were selected, (1)600 healthy subjects were selected for the immunogenicity and safety study of co-immunization, 300 in the adult group (18-59 years old) and 300 in the elderly group (60 years old and above); (2) 2400 healthy subjects were selected for the observational study of the safety of co-immunization, 1200 in the adult group (18-59 years old) and 1200 in the elderly group (60 years old and above ) 1200 people.

Official Title
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Clinical Observation of Combined Immunization of COVID-19 Inactivated Vaccine With Quadrivalent Influenza Vaccine(QIV) and 23-valent Pneumococcal Polysaccharide Vaccine

Conditions
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Safety, Immunogenicity, Vaccine, COVID-19 Vaccines, Influenza Vaccines, Pneumococcal Vaccines

Intervention / Treatment
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* Biological: Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults 18 years old and older Over 6 months after primary immunization with COVID-19 vaccines Can understand and sign the consent Can provide effective personal identification Exclusion Criteria: Has a history of COVID-19 infection Less than 6 months after primary immunization with COVID-19 vaccines Already vaccinated with influenza vaccines of that year Vaccinated with pneumococcal vaccines within 5 years Has a history of severe hypersensitivity reaction to vaccines Has uncontrolled seizure or other severe neural system illnesses Has a fever, chronic disease, or acute disease during immunization Gestation period, lactation period, or planning to get pregnant within 3 months Administrated with other drugs under research within 30 days before vaccination Received attenuated vaccines within 14 days before vaccination Received subunit vaccines or inactivated vaccines within 7 days before vaccination Other conditions based on researcher's judgement

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID-19 and QIV<br> | Biological: Vaccine<br>* Different arms were administrated different vaccines<br>|
| Experimental: COVID-19 and PPV23<br> | Biological: Vaccine<br>* Different arms were administrated different vaccines<br>|
| Experimental: COVID-19<br> | Biological: Vaccine<br>* Different arms were administrated different vaccines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate of neutralizing antibody |  | 28 days after the third dose of COVID-19 vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety;Immunogenecity;Combined Immunization