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

Centers for Disease Control and Prevention, China

Status and phase: Unknown; Phase 4

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

Treatments: Biological: Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05298800

BJCDCWJ202202

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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3,000 participants in 3 patient groups

COVID-19 and QIV

Experimental group

Treatment:

Biological: Vaccine

COVID-19 and PPV23

Experimental group

Treatment:

Biological: Vaccine

COVID-19

Experimental group

Treatment:

Biological: Vaccine