Immune ResponsePhase 4NCT05970887
Immunogenicity and Safety of Concomitant Administration of Bivalent COVID-19 Vaccines With Influenza Vaccines
A Phase 4 study testing bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine and quadrivalent influenza vaccine in people with Immune Response and Safety, run by Catholic Kwandong University at 1 site in South Korea.
Trial summary
The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthy adults during 2022-23 season. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Response, Safety
- What is being tested?
- bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine and quadrivalent influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Oct 2022to 15 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- who agreed to receive both bivalent booster COVID-19 vaccine and influenza vaccine
- Only individuals who had passed at least 3 months after the last confirmation of SARS-CoV-2 infection and/or the third dose of COVID-19 vaccination
Who cannot join
- Individuals with a contraindication to any of the vaccine compounds were excluded from the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
International St. Mary's hospital
Incheon, Seo-gu, 22711
About this study
Official title: Immunogenicity and Safety of Concomitant Administration of Omicron-containing Bivalent COVID-19 Vaccines With Seasonal Influenza Vaccines
The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthy adults during 2022-23 season.
Read the detailed description
This was an open-label, non-randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of bivalent BA.4/BA.5 mRNA COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later
- immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks (day 28±7) after immunization.
- safety analysis : At 7 days after each vaccine dose, the participants were requested to record the occurrence, severity of solicited adverse events (AEs) through a standardized electronic questionnaire. Participants were also asked to record any unsolicited AEs during the 28 days after vaccination.
- Conditions
- Immune Response, Safety
- Being tested
- bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine, quadrivalent influenza vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccineBiological
The bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine is a combination of 15-µg of mRNA encoding the wild-type (WT) spike protein and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariant.
quadrivalent influenza vaccineBiological
The quadrivalent influenza vaccine is an inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2022-2023 northern hemisphere season
| Study group | Role | What they receive |
|---|---|---|
| C group | Experimental | Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination Receives: Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine; Biological: quadrivalent influenza vaccine |
| S group (COVID-19 vaccine only) | Placebo comparator | separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later Receives: Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine |
| S group (influenza vaccine only) | Placebo comparator | separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later Receives: Biological: quadrivalent influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups
seroconversion rate of anti-SARS-CoV-2 S IgG
Measured: at 28 days after booster dose
Secondary outcomes (6)
seroconversion rate of neutralizing antibody against SARS-CoV-2
seroconversion rate of neutralizing antibody against wild type, Omicron BA.5
Measured: at 28 days after booster dose
geometric mean titer against SARS-CoV-2
geometric mean titer against SARS-CoV-2 (Anti-S IgG, neutralizing antibody)
Measured: at 28 days after booster dose
seroconversion rate of four influenza strains
seroconversion rate of four influenza strains
Measured: at 28 days after immunization
seropositive rate of four influenza strains
seropositive rate of four influenza strains
Measured: at 28 days after immunization
geometric mean titer against four influenza strain
geometric mean titer against four influenza strain
Measured: at 28 days after immunization
The incidence rate of adverse events (AEs)
The incidence rate of AEs within 7 days, AEs within 28 days, and serious AEs
Measured: within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start12 Oct 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponseStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective, non-randomized clinical cohort study
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic Kwandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Guro Hospital
- Responsible party
- Principal investigator, Min Joo Choi, Catholic Kwandong University
- Investigators
- Min Joo Choi, Doctor, Principal investigator, International St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970887
- Sponsor's protocol ID
- IS22OISE0060
- Status last verified
- Mar 2024
- First submitted
- 28 Jul 2023
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Concomitant Administration of Omicron-containing Bivalent COVID-19 Vaccines With Seasonal Influenza Vaccines
- ClinicalTrials.gov ID
- NCT05970887
- Acronym / sponsor ID
- IS22OISE0060
- Conditions
- Immune Response, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Catholic Kwandong UniversityUniversity, hospital or other
- Collaborators
- Korea University Guro Hospital
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 1 Aug 2023 (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 goal is to evaluate the immunogenicity and safety of coadministration of a bivalent BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthy adults during 2022-23 season.
Detailed description
This was an open-label, non-randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of bivalent BA.4/BA.5 mRNA COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later
- immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks (day 28±7) after immunization.
- safety analysis : At 7 days after each vaccine dose, the participants were requested to record the occurrence, severity of solicited adverse events (AEs) through a standardized electronic questionnaire. Participants were also asked to record any unsolicited AEs during the 28 days after vaccination.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective, non-randomized clinical cohort study
| Arm | Type | Receives |
|---|---|---|
| C group | Experimental | Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine, Biological: quadrivalent influenza vaccineConcomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination |
| S group (COVID-19 vaccine only) | Placebo comparator | Biological: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccineseparate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later |
| S group (influenza vaccine only) | Placebo comparator | Biological: quadrivalent influenza vaccineseparate administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- who agreed to receive both bivalent booster COVID-19 vaccine and influenza vaccine
- Only individuals who had passed at least 3 months after the last confirmation of SARS-CoV-2 infection and/or the third dose of COVID-19 vaccination
Key exclusion criteria (1 listed)
- Individuals with a contraindication to any of the vaccine compounds were excluded from the study
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 |
|---|---|---|
| bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccineThe bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine is a combination of 15-µg of mRNA encoding the wild-type (WT) spike protein and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariant. | Biological | C group, S group (COVID-19 vaccine only) |
| quadrivalent influenza vaccineThe quadrivalent influenza vaccine is an inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2022-2023 northern hemisphere season | Biological | C group, S group (influenza vaccine only) |
Primary outcome
seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups
Time frame: at 28 days after booster dose
seroconversion rate of anti-SARS-CoV-2 S IgG
6 secondary outcomes
seroconversion rate of neutralizing antibody against SARS-CoV-2
Time frame: at 28 days after booster dose
geometric mean titer against SARS-CoV-2
Time frame: at 28 days after booster dose
seroconversion rate of four influenza strains
Time frame: at 28 days after immunization
seropositive rate of four influenza strains
Time frame: at 28 days after immunization
geometric mean titer against four influenza strain
Time frame: at 28 days after immunization
The incidence rate of adverse events (AEs)
Time frame: within 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Min Joo Choi, Doctor principal investigator
International St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine and quadrivalent influenza vaccine in people with Immune Response and Safety, run by Catholic Kwandong University at 1 site in South Korea.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups (time frame: at 28 days after booster dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2024.