Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23
QIV;PPV23
Clinical Observation of Combined Immunization of COVID-19 Inactivated Vaccine With Quadrivalent Influenza Vaccine(QIV) and 23-valent Pneumococcal Polysaccharide Vaccine
1 other identifier
interventional
3,000
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2021
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2021
CompletedFirst Submitted
Initial submission to the registry
March 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 28, 2022
March 1, 2022
1.2 years
March 18, 2022
March 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroconversion rate of neutralizing antibody
28 days after the third dose of COVID-19 vaccine
Study Arms (3)
COVID-19 and QIV
EXPERIMENTALCOVID-19 and PPV23
EXPERIMENTALCOVID-19
EXPERIMENTALInterventions
Different arms were administrated different vaccines
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Related Publications (2)
Bai S, Zhou S, Zhang J, Chen W, Lv M, Wang J, Zhang A, Wu J, Zhao W. Immunogenicity and safety of different combinations involving a third booster dose of SARS-CoV-2 inactivated vaccine, inactivated quadrivalent influenza vaccine, and 23-valent pneumococcal polysaccharide vaccine in adults aged >/=60 years: a phase 4, randomized, open-label study. Front Immunol. 2024 Aug 20;15:1437267. doi: 10.3389/fimmu.2024.1437267. eCollection 2024.
PMID: 39229259DERIVEDZhou S, Lv M, Bai S, Chen W, Zhao W, Wang J, Zhang A, Li J, Xie H, Gao Y, Li D, Wu J. Baseline Pneumococcal IgG Levels and Response to 23-Valent Pneumococcal Polysaccharide Vaccine among Adults from Beijing, China. Vaccines (Basel). 2023 Nov 29;11(12):1780. doi: 10.3390/vaccines11121780.
PMID: 38140184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director，Head of the Institute for Vaccines and Immunization
Study Record Dates
First Submitted
March 18, 2022
First Posted
March 28, 2022
Study Start
October 8, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2023
Last Updated
March 28, 2022
Record last verified: 2022-03