Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to learn about safety in participants taking the study vaccine (mRNA-based vaccine) and the ability of the study vaccine to trigger the body's immune response, targeting the flu virus (influenza virus).
This study is seeking healthy participants 18 years of age or older. All participants in this study will receive only 1 dose in their arm, to deliver one of the experimental flu vaccines or one of the approved flu vaccines used for comparison.
Participants will take part in this study for about 6 months, and participants will need to visit the study site at least 3 times. A blood sample will be taken at each of the 3 planned study visits and a swab from inside the nose will be taken at the first study visit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | mRNA influenza vaccine candidate #1 as a single intramuscular (IM) injection on Day 1. |
|
| B | Experimental | mRNA influenza vaccine candidate #2 as a single IM injection on Day 1. |
|
| C | Experimental | mRNA influenza vaccine candidate #3 as a single IM injection on Day 1. |
|
| D | Experimental | mRNA influenza vaccine candidate #4 as a single IM injection on Day 1. |
|
| E | Experimental | mRNA influenza vaccine candidate #5 as a single IM injection on Day 1. |
|
| F | Experimental | mRNA influenza vaccine candidate #6 as a single IM injection on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine Candidate #1 | Biological | Investigational influenza Vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting prespecified local reactions following vaccination | Within 7 days after vaccination | |
| Percentage of participants reporting prespecified systemic events following vaccination. | Within 7 days after vaccination | |
| Percentage of participants reporting adverse events (AEs) following vaccination. | Within 1 month after vaccination | |
| Percentage of participants reporting serious adverse events (SAEs) following vaccination. | Within 6 months after vaccination | |
| Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) following vaccination. | Within 6 months after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine. | Before vaccination and at 4 weeks after vaccination | |
| Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to each of the influenza antigens of the vaccine |
Not provided
Inclusion Criteria
• Healthy and medically stable participants who are determined by medical history, physical examination (if clinically required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMR Clinical | Recruiting | Mobile | Alabama | 36608 | United States | |
| Diablo Clinical Research, LLC d/b/a Flourish Research |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| G | Active Comparator | Licensed influenza vaccine (TIV1 or TIV2) as a single IM injection. |
|
| Vaccine Candidate #2 |
| Biological |
Investigational influenza Vaccine |
|
| Vaccine Candidate #3 | Biological | Investigational Influenza Vaccine |
|
| Vaccine Candidate #4 | Biological | Investigational Influenza Vaccine |
|
| Vaccine Candidate #5 | Biological | Investigational Influenza Vaccine |
|
| Vaccine Candidate #6 | Biological | Investigational Influenza Vaccine |
|
| TIV1 or TIV2 | Biological | Licensed influenza vaccine |
|
| Before vaccination to 4 weeks after vaccination |
| Percentage of participants with satisfactory antibody response to the vaccine. | Before vaccination to 4 weeks after vaccination |
| Recruiting |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Clinical Research Consulting, LLC | Recruiting | Milford | Connecticut | 06460 | United States |
| George Washington Medical Faculty Associates | Recruiting | Washington D.C. | District of Columbia | 20037 | United States |
| Indago Research & Health Center, Inc | Recruiting | Hialeah | Florida | 33012 | United States |
| Palm Springs Community Health Center | Recruiting | Miami Lakes | Florida | 33014 | United States |
| Clinical Research Atlanta | Recruiting | Stockbridge | Georgia | 30281 | United States |
| East-West Medical Research Institute | Recruiting | Honolulu | Hawaii | 96814 | United States |
| AMR Clinical | Recruiting | Kansas City | Missouri | 64114 | United States |
| Rochester Clinical Research, LLC | Recruiting | Rochester | New York | 14609 | United States |
| DM Clinical Research - Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| SMS Clinical Research LLC | Recruiting | Mesquite | Texas | 75149 | United States |
| DM Clinical Research | Recruiting | Tomball | Texas | 77375 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic | Recruiting | Salt Lake City | Utah | 84109 | United States |
| Charlottesville Medical Research Center, LLC | Recruiting | Charlottesville | Virginia | 22911 | 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 |
Not provided
Not provided