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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 and QIV | Experimental |
| |
| COVID-19 and PPV23 | Experimental |
| |
| COVID-19 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine | Biological | Different arms were administrated different vaccines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate of neutralizing antibody | 28 days after the third dose of COVID-19 vaccine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Wu, Bachelor | Contact | 13381081732 | wj81732@hotmail.com | |
| Shuang Bai, Postgraduate | Contact | 15210178395 | summer012388@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daxing District Center of Disease Control and Prevention | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39229259 | Derived | 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. | |
| 38140184 |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Huairou District Center of Disease Control and Prevention | Recruiting | Beijing | China |
|
| Miyun District Center of Disease Control and Prevention | Recruiting | Beijing | China |
|
| Derived |
| Zhou 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. |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |