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

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-08

Study Completion Date

2023-12-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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COVID-19 and QIV

Group Type EXPERIMENTAL

Vaccine

Intervention Type BIOLOGICAL

Different arms were administrated different vaccines

COVID-19 and PPV23

Group Type EXPERIMENTAL

Vaccine

Intervention Type BIOLOGICAL

Different arms were administrated different vaccines

COVID-19

Group Type EXPERIMENTAL

Vaccine

Intervention Type BIOLOGICAL

Different arms were administrated different vaccines

Interventions

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Vaccine

Different arms were administrated different vaccines

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes