SafetyPhase 4QIV;PPV23NCT05298800
Combined Immunization of COVID-19 Inactivated Vaccine With QIV and PPV23
A Phase 4 study testing Vaccine in people with Safety and Immunogenicity, Vaccine, run by Centers for Disease Control and Prevention, China at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety, Immunogenicity, Vaccine, COVID-19 Vaccines
- What is being tested?
- Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 3 sitesChina
- Study dates
- 8 Oct 2021to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Daxing District Center of Disease Control and Prevention
Beijing
Xin Song, 13810711075
- Recruiting
Huairou District Center of Disease Control and Prevention
Beijing
Zhiquan Wei, 15201231087
- Recruiting
Miyun District Center of Disease Control and Prevention
Beijing
Siyao Li, 1851596 9266
About this study
Official title: Clinical Observation of Combined Immunization of COVID-19 Inactivated Vaccine With Quadrivalent Influenza Vaccine(QIV) and 23-valent Pneumococcal Polysaccharide Vaccine
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.
- Conditions
- Safety, Immunogenicity, Vaccine, COVID-19 Vaccines, Influenza Vaccines, Pneumococcal Vaccines
- Being tested
- Vaccine
- Keywords
- Safety;Immunogenecity;Combined Immunization
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaccineBiological
Different arms were administrated different vaccines
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 and QIV | Experimental | Not described Receives: Biological: Vaccine |
| COVID-19 and PPV23 | Experimental | Not described Receives: Biological: Vaccine |
| COVID-19 | Experimental | Not described Receives: Biological: Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate of neutralizing antibody
Measured: 28 days after the third dose of COVID-19 vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start8 Oct 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention, China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wu Jiang, Centers for Disease Control and Prevention, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298800
- Sponsor's protocol ID
- BJCDCWJ202202
- Acronym
- QIV;PPV23
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39229259Zhou 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.
PubMed 38140184
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Combined Immunization of COVID-19 Inactivated Vaccine With Quadrivalent Influenza Vaccine(QIV) and 23-valent Pneumococcal Polysaccharide Vaccine
- ClinicalTrials.gov ID
- NCT05298800
- Acronym / sponsor ID
- QIV;PPV23 / BJCDCWJ202202
- Conditions
- Safety, Immunogenicity, Vaccine, COVID-19 Vaccines, Influenza Vaccines, Pneumococcal Vaccines
- Keywords
- Safety;Immunogenecity;Combined Immunization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 and QIV | Experimental | Biological: Vaccine |
| COVID-19 and PPV23 | Experimental | Biological: Vaccine |
| COVID-19 | Experimental | Biological: Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VaccineDifferent arms were administrated different vaccines | Biological | COVID-19, COVID-19 and PPV23, COVID-19 and QIV |
Primary outcome
Seroconversion rate of neutralizing antibody
Time frame: 28 days after the third dose of COVID-19 vaccine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Derived from this study: PubMed 39229259Bai 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.
- Derived from this study: PubMed 38140184Zhou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaccine in people with Safety and Immunogenicity, Vaccine, run by Centers for Disease Control and Prevention, China at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Wu, Bachelor (13381081732, wj81732@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate of neutralizing antibody (time frame: 28 days after the third dose of COVID-19 vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05298800, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.