COVID-19Phase 4NCT06091410
Immunogenicity of Concomitant Administration of COVID-19 Vaccines With Influenza Vaccines
A Phase 4 study testing Omicron-containing COVID-19 vaccine and influenza vaccine in people with COVID-19 and Influenza, run by Catholic Kwandong University at 2 sites in South Korea.
Trial summary
The goal is to evaluate the in-depth immunogenicity analysis (including B-cell and T-cell response) of coadministration of a omicron-containing COVID-19 vaccine and influenza vaccine among healthy adults during 2023-24 season. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Influenza, Vaccine Reaction
- What is being tested?
- Omicron-containing COVID-19 vaccine and influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 25 Sep 2023to 25 Jun 2025
- 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 booster COVID-19 vaccine and influenza vaccine
- individuals who have received the COVID-19 vaccine three or more times and have passed at least 3 months after the last vaccination
- individuals with a history of a single SARS-CoV-2 infection during the Omicron outbreak period (January 2022-February 2023)
Who cannot join
- individuals with a contraindication to any of the vaccine compounds
- individuals with a history of influenza infection within the past 6 months
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
International St. Mary's hospital
Incheon, Seo-gu, 22711
Korea University Guro Hospital
Seoul, Guro-gu, 08308
About this study
Official title: Immunogenicity of Concomitant Administration of Omicron-containing COVID-19 Vaccines With Influenza Vaccines : In-depth Immunogenicity Analysis.
The goal is to evaluate the in-depth immunogenicity analysis (including B-cell and T-cell response) of coadministration of a omicron-containing COVID-19 vaccine and influenza vaccine among healthy adults during 2023-24 season.
Read the detailed description
This was an open-label, randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of omicron containing messenger ribonucleic acid (mRNA) COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by mRNA booster ≥4 weeks later
- immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks, 3 months, 6 months, 10-12 months after immunization(For the COVID-19 vaccine, additional blood sampling will be conducted one week after vaccination).
- 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
- COVID-19, Influenza, Vaccine Reaction, Contaminant Injected
- Being tested
- Omicron-containing COVID-19 vaccine, influenza vaccine
- Keywords
- COVID-19 vaccine, influenza vaccine, immunogenicity, co-administration
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omicron-containing COVID-19 vaccineBiological
The COVID-19 vaccine approved for use in the 2023-2024 season
influenza vaccineBiological
inactivated vaccine containing 15μg hemagglutinin antigen/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season
| Study group | Role | What they receive |
|---|---|---|
| C group | Experimental | concomitant administration of COVID-19 booster and quadrivalent influenza vaccination Receives: Biological: Omicron-containing COVID-19 vaccine; Biological: influenza vaccine |
| S group (COVID-19 vaccine only) | Placebo comparator | separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later Receives: Biological: Omicron-containing COVID-19 vaccine |
| S group (influenza vaccine only) | Placebo comparator | separate administration of influenza vaccination followed by COVID-19 booster 4 weeks later Receives: Biological: influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
geometric mean titer against SARS-CoV-2 (Anti-S immunoglobulin G, Neutralizing antibody)
Measured: at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination
Secondary outcomes (4)
geometric mean titer against four influenza strain
geometric mean titer against four influenza strain
Measured: at 28 days and 7 months after influenza vaccination
vaccine-induced B-cell responses
vaccine-induced B-cell responses and their immune interactions between COVID-19 and influenza vaccines
Measured: at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination
vaccine-induced CD4+ T cell responses
vaccine-induced CD4+ T cell responses and their immune interactions between COVID-19 and influenza vaccines
Measured: at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination
The incidence rate of adverse events
The incidence rate of adverse events within 7 days, 28 days, and serious adverse events
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 posted19 Oct 2023
- Study start25 Sep 2023
- Primary completion25 Feb 2025 (estimated)
- Study completion25 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized clinical cohort study
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic Kwandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Guro Hospital
- Responsible party
- Sponsor
- Investigators
- Min Joo Choi, Principal investigator, International St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091410
- Sponsor's protocol ID
- IS23OIME0055
- Status last verified
- Mar 2024
- First submitted
- 17 Oct 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 of Concomitant Administration of Omicron-containing COVID-19 Vaccines With Influenza Vaccines : In-depth Immunogenicity Analysis.
- ClinicalTrials.gov ID
- NCT06091410
- Acronym / sponsor ID
- IS23OIME0055
- Conditions
- COVID-19, Influenza, Vaccine Reaction, Contaminant Injected
- Keywords
- COVID-19 vaccine, influenza vaccine, immunogenicity, co-administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Catholic Kwandong UniversityUniversity, hospital or other
- Collaborators
- Korea University Guro Hospital
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 25 Feb 2025 (estimated)
- Study completion
- 25 Jun 2025 (estimated)
- First posted
- 19 Oct 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 in-depth immunogenicity analysis (including B-cell and T-cell response) of coadministration of a omicron-containing COVID-19 vaccine and influenza vaccine among healthy adults during 2023-24 season.
Detailed description
This was an open-label, randomized clinical trial conducted at the International St. Mary's Hospital in Incheon, South Korea. This study included two study groups: Concomitant administration of omicron containing messenger ribonucleic acid (mRNA) COVID-19 booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza vaccination followed by mRNA booster ≥4 weeks later
- immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks, 3 months, 6 months, 10-12 months after immunization(For the COVID-19 vaccine, additional blood sampling will be conducted one week after vaccination).
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective, randomized clinical cohort study
| Arm | Type | Receives |
|---|---|---|
| C group | Experimental | Biological: Omicron-containing COVID-19 vaccine, Biological: influenza vaccineconcomitant administration of COVID-19 booster and quadrivalent influenza vaccination |
| S group (COVID-19 vaccine only) | Placebo comparator | Biological: Omicron-containing COVID-19 vaccineseparate administration of influenza vaccination followed by COVID-19 booster 4 weeks later |
| S group (influenza vaccine only) | Placebo comparator | Biological: influenza vaccineseparate administration of influenza vaccination followed by COVID-19 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 (3 listed)
- who agreed to receive both booster COVID-19 vaccine and influenza vaccine
- individuals who have received the COVID-19 vaccine three or more times and have passed at least 3 months after the last vaccination
- individuals with a history of a single SARS-CoV-2 infection during the Omicron outbreak period (January 2022-February 2023)
Key exclusion criteria (2 listed)
- individuals with a contraindication to any of the vaccine compounds
- individuals with a history of influenza infection within the past 6 months
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 |
|---|---|---|
| Omicron-containing COVID-19 vaccineThe COVID-19 vaccine approved for use in the 2023-2024 season | Biological | C group, S group (COVID-19 vaccine only) |
| influenza vaccineinactivated vaccine containing 15μg hemagglutinin antigen/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2023-2024 northern hemisphere season | Biological | C group, S group (influenza vaccine only) |
Primary outcome
geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Time frame: at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination
geometric mean titer against SARS-CoV-2 (Anti-S immunoglobulin G, Neutralizing antibody)
4 secondary outcomes
geometric mean titer against four influenza strain
Time frame: at 28 days and 7 months after influenza vaccination
vaccine-induced B-cell responses
Time frame: at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination
vaccine-induced CD4+ T cell responses
Time frame: at 7, 28 days, 6, and 10-12 months after COVID-19 vaccination
The incidence rate of adverse events
Time frame: within 28 days
Results and safety
Results are not available in the source record.
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 principal investigator
International St. Mary's Hospital
2 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 Omicron-containing COVID-19 vaccine and influenza vaccine in people with COVID-19 and Influenza, run by Catholic Kwandong University at 2 sites 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 3 inclusion and 2 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 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 2 sites 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?
Results are not available in the source record.
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?
geometric mean titer against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (time frame: at 7, 28 days, 3, 6, and 10-12 months after COVID-19 vaccination). 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.