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This study, a pilot randomized controlled trial, single-blind (outcome assessor), evaluating the immune response (both humoral and cell-mediated) against SARS-CoV-2 and the safety of three different vaccine administration approaches: the SARS-CoV-2 mRNA vaccine alone, the influenza vaccine alone, and the co-administration of both vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bivalent mRNA BNT162b2 | Active Comparator | Administering a booster dose of the bivalent mRNA vaccine BNT162b2. |
|
| Quardrivalent influenza vaccine | Experimental | Administering a VaxigripTetra™ |
|
| Co-administration | Experimental | Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bivalent mRNA SARS-CoV-2 vaccine | Biological | Administering a booster dose of the bivalent mRNA vaccine BNT162b2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline | IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay | Before vaccination |
| Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at 4 Weeks | IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay | 4 weeks post vaccination |
| Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at Baseline | IgG response against the SARS-CoV-2 virus, measured by ELISA. | before vaccination |
| Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at 4 Weeks | IgG response against the SARS-CoV-2 virus, measured by ELISA. | 4 weeks post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarunyou Chusri, M.D., Ph.D. | Prince of Songkla University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Prince of Songkla University | Songkhla | 90110 | Thailand |
The data will be kept anonymized.
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A total of 42 adults were screened for eligibility. Six were excluded because of uncontrolled chronic diseases, leaving 36 participants who were randomized.
Volunteers were recruited between March and April 2024 at Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand.
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| ID | Title | Description |
|---|---|---|
| FG000 | COVID-19 vaccine | Administering a booster dose of the bivalent mRNA vaccine BNT162b2 and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination |
| FG001 | Influenza vaccine | Administering a VaxigripTetra™ and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination |
| FG002 | Co-administration | Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | COVID-19 Vaccine | Administering a booster dose of the bivalent mRNA vaccine BNT162b2 and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination |
| BG001 | Influenza Vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at Baseline | IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay | Posted | Geometric Mean | 95% Confidence Interval | SFCs/10⁶ PBMCs | Before vaccination |
|
From vaccination until 28 days post vaccination
Pre-specified adverse events included solicited local and systemic reactions, assessed at Day 7 and Day 28 post-vaccination. Unsolicited adverse events were monitored daily from Day 1 through Day 28. Serious adverse events were monitored throughout Days 1-28.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COVID-19 vaccine | Administering a booster dose of the bivalent mRNA vaccine BNT162b2 and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness at injection site | Musculoskeletal and connective tissue disorders | Systematic Assessment |
As a single-center pilot study with a limited number of participants, the findings may not be generalizable. The short follow-up duration also restricts conclusions about long-term safety and immune responses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarunyou Chusri | prince of songkla university | +66897340446 | sarunyouchusri@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 2, 2024 | Sep 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Quardrivalent influenza vaccine | Biological | Administering a VaxigripTetra™ |
|
Administering a VaxigripTetra™ and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination
| BG002 | Co-administration | Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination |
| BG003 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Duration from last COVID-19 vaccination | Duration from last COIVD-19 vaccine dose, any type of vaccines | Median | Inter-Quartile Range | week |
|
| OG002 |
| Co-administration |
Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination |
|
|
| Primary | Geometric Mean (GM) of Interferon-gamma (IFN-γ) Response Against the SARS-CoV-2 Virus at 4 Weeks | IFN-γ response against the SARS-CoV-2 virus, measured by the ELISpot assay | Posted | Geometric Mean | 95% Confidence Interval | SFCs/10⁶ PBMCs | 4 weeks post vaccination |
|
|
|
| Primary | Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at Baseline | IgG response against the SARS-CoV-2 virus, measured by ELISA. | Posted | Geometric Mean | 95% Confidence Interval | BAU/mL | before vaccination |
|
|
|
| Primary | Geometric Mean (GM) of IgG Response Against the SARS-CoV-2 Virus at 4 Weeks | IgG response against the SARS-CoV-2 virus, measured by ELISA. | Posted | Geometric Mean | 95% Confidence Interval | BAU/mL | 4 weeks post vaccination |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | Influenza vaccine | Administering a VaxigripTetra™ and evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination | 0 | 12 | 0 | 12 | 10 | 12 |
| EG002 | Co-administration | Co-administering bivalent mRNA vaccine BNT162b2 and VaxigripTetra™, then evaluate immune response against SARS-CoV-2 at baseline and 4 week post-vaccination | 0 | 12 | 0 | 12 | 12 | 12 |
| pain at injection site | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| swelling at injection site | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| mass at injection site | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Malaise | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| fever | Immune system disorders | Systematic Assessment |
|
| dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
| Male |
|