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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05227001 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07852352 Influenza saRNA, low dose | Experimental |
| |
| PF-07852352 Influenza saRNA, mid dose | Experimental |
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| PF-07852352 Influenza saRNA, high dose | Experimental |
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| PF-07836391 Influenza saRNA, low dose | Experimental |
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| PF-07836391 Influenza saRNA, mid dose | Experimental |
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| PF-07836391 Influenza saRNA, high dose | Experimental |
| |
| PF-07836394 Influenza saRNA, low dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07852352 Influenza saRNA 1 | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting local reactions | Pain at the injection site, redness, and swelling, as self-reported in electronic diaries. | For 10 days after vaccination |
| Percentage of participants reporting systemic events | Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self reported in electronic diaries. | For 10 days after vaccination |
| Percentage of participants reporting adverse events | As elicited by investigational site staff. | From vaccination to 4 weeks after vaccination |
| Percentage of participants reporting serious adverse events | As elicited by investigational site staff. | From vaccination to 6 months after vaccination |
| Percentage of participants with abnormal hematology and chemistry laboratory values | As measured at the central laboratory | 2 days after vaccination |
| Percentage of participants with abnormal hematology and chemistry laboratory values | As measured at the central laboratory | 1 week after vaccination |
| Percentage of participants with grading shifts in hematology and chemistry laboratory assessments | As measured at the central laboratory. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers | As measured at the central laboratory | At Baseline, and 1-, 2- and 4-weeks after vaccination |
| Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Rhythm Center | Phoenix | Arizona | 85016 | United States | ||
| Hope Research Institute |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| PF-07836394 Influenza saRNA, mid dose | Experimental |
|
| PF-07836394 Influenza saRNA, high dose | Experimental |
|
| PF-07836395 Influenza saRNA, low dose | Experimental |
|
| PF-07836395 Influenza saRNA, mid dose | Experimental |
|
| PF-07836395 Influenza saRNA, high dose | Experimental |
|
| PF-07836396 Influenza saRNA, low dose | Experimental |
|
| PF-07836396 Influenza saRNA, mid dose | Experimental |
|
| PF-07836396 Influenza saRNA, high dose | Experimental |
|
| PF-07867246 Influenza saRNA, mid dose | Experimental |
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| PF-07867246 Influenza saRNA, low dose | Experimental |
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| PF-07867246 Influenza saRNA, high dose | Experimental |
|
| Placebo | Placebo Comparator |
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| Quadrivalent influenza vaccine (QIV) | Active Comparator |
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| PF-07871987 Influenza saRNA, low dose | Experimental |
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| PF-07871987 Influenza saRNA, mid dose | Experimental |
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| PF-07871987 Influenza saRNA, high dose | Experimental |
|
| PF-07914705 Influenza saRNA mid dose | Experimental |
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| PF-07914705 Influenza saRNA, high dose | Experimental |
|
| PF-07915048 Influenza saRNA, high dose | Experimental |
|
| PF-07836391 Influenza saRNA | Biological | Intramuscular injection |
|
| PF-07836394 Influenza saRNA | Biological | Intramuscular injection |
|
| PF-07836395 Influenza saRNA | Biological | Intramuscular injection |
|
| PF-07836396 Influenza saRNA | Biological | Intramuscular injection |
|
| PF-07867246 Influenza saRNA | Biological | Intramuscular injection |
|
| Placebo | Biological | Intramuscular injection |
|
| Quadrivalent influenza vaccine (QIV) | Biological | Intramuscular injection |
|
| PF-07871987 Influenza saRNA | Biological | Intramuscular injection |
|
| PF-07914705 Influenza saRNA | Biological | Intramuscular injection |
|
| PF-07915048 Influenza saRNA | Biological | Intramuscular injection |
|
| Between baseline and 2 days after vaccination |
| Percentage of participants with grading shifts in hematology and chemistry laboratory assessments | As measured at the central laboratory | Between baseline and 1 week after vaccination |
| Percentage of participants with new electrocardiogram (ECG) abnormalities | ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist | 2 days after vaccination |
| Percentage of participants with new ECG abnormalities | ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist | 1 week after vaccination |
As measured at the central laboratory |
| At Baseline, and 1-, 2- and 4-weeks after vaccination |
| Proportion of participants achieving HAI seroconversion for each strain | As measured at the central laboratory | At 1-, 2-, and 4-weeks after vaccination |
| Proportion of participants with HAI titer >=1:40 for each strain | As measured at the central laboratory | At Baseline, and 1-, 2-, and 4-weeks after vaccination |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| The Pain Center of Arizona | Phoenix | Arizona | 85018 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Finlay Medical Research | Greenacres City | Florida | 33467 | United States |
| Advanced Pharma CR, LLC | Miami | Florida | 33147 | United States |
| Miami Clinical Research | Miami | Florida | 33155 | United States |
| Mount Sinai Hospital | Miami Beach | Florida | 33140 | United States |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | United States |
| Pines Care Research Center, LLC | Pembroke Pines | Florida | 33024 | United States |
| Pinnacle Health Care Center | Pembroke Pines | Florida | 33024 | United States |
| Comprehensive Cardiology Consultants | Pembroke Pines | Florida | 33028 | United States |
| Great Lakes Clinical Trials - Andersonville | Chicago | Illinois | 60640 | United States |
| Pioneer Heart Institute | Lincoln | Nebraska | 68506 | United States |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | 68134 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| SUNY Upstate Medical University Global Health Laboratory | Syracuse | New York | 13210 | United States |
| SUNY Upstate Medical University Institute for Global Health | Syracuse | New York | 13215 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13215 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Eric S. Tiblier, MD | Austin | Texas | 78705 | United States |
| DM Clinical Research, Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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