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

Phase 4

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

• Registration Number: NCT05298800
• Lead Sponsor: Centers for Disease Control and Prevention, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-08
• Status Verified: 2022-03
• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-24
• Last Update Submitted: 2022-03-24
• Study First Posted: 2022-03-28
• Last Update Posted: 2022-03-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
COVID-19 and QIV	Vaccine	-
COVID-19 and PPV23	Vaccine	-
COVID-19	Vaccine	-

Primary Outcome Measures

Name	Time	Method
Seroconversion rate of neutralizing antibody	28 days after the third dose of COVID-19 vaccine

Trial Locations

Locations (3)

Daxing District Center of Disease Control and Prevention; 🇨🇳 Beijing, China

Huairou District Center of Disease Control and Prevention; 🇨🇳 Beijing, China

Miyun District Center of Disease Control and Prevention; 🇨🇳 Beijing, China