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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06179446 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine.
This study is seeking for participants who are:
Participants will receive either:
Participants will not know which vaccine they receive. Participants will receive the study vaccines as a single shot in the arm. The study will compare participant experiences to help understand if the pdmFlu vaccine is safe and effective. Participants will take part in this study for up to 13 months. During this time, the participants will receive the study vaccine and take part in follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pdmFlu vaccine 1 | Experimental |
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| pdmFlu vaccine 2 | Experimental |
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| pdmFlu vaccine 3 | Experimental |
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| pdmFlu vaccine 4 | Experimental |
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| pdmFlu vaccine 5 | Experimental |
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| pdmFlu vaccine 6 | Experimental |
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| pdmFlu vaccine 7 | Experimental |
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| pdmFlu vaccine 8 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pdmFlu vaccine | Biological | Intramuscular injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants by age group reporting local reactions | For 7 days after vaccination | |
| Percentage of participants by age group reporting systemic events | For 7 days after vaccination | |
| Percentage of participants by age group reporting adverse events | From vaccination to 4 weeks after each vaccination | |
| Percentage of participants by age group reporting serious adverse events | From vaccination to 6 months after last vaccination or through the last visit, whichever is longer | |
| Percentage of participants by age group reporting medically attended adverse events | From vaccination to 6 months after last vaccination or through the last visit, whichever is longer | |
| Percentage of participants by age group with abnormal hematology and chemistry laboratory values | 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination | |
| Percentage of participants by age group with grading shifts in hematology and chemistry laboratory assessments | Between baseline and 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination | |
| Percentage of participants by age group with new clinically significant ECG abnormalities | 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers | At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination | |
| Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint |
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Key Inclusion Criteria:
- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Key Exclusion Criteria:
- Does not meet seasonal influenza vaccine requirements per cohort.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | New Haven | Connecticut | 06511 | United States | ||
| Research Centers of America |
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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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| Placebo | Placebo Comparator |
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| Licensed influenza vaccine | Active Comparator |
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| Placebo | Biological | Intramuscular injection |
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| Licensed influenza vaccine | Biological | Intramuscular injection |
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| Percentage of participants by age group with new troponin I abnormalities | 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks after vaccination 1, 1 week and 4 weeks after vaccination 2, 1 week and 4 weeks after booster vaccination |
| At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination |
| Proportion of participants by age group achieving HAI seroconversion | At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination |
| Proportion of participants by age group with HAI titer >=1:40 | At baseline, 1 week, 3 weeks, 6 weeks, 8 weeks and 12 weeks, 16 weeks and 6 months after vaccination 1, 1 week, 4 weeks, 3 months and 6 months after vaccination 2, 1 week, 4 weeks, 12 weeks and 6 months after booster vaccination |
| Hollywood |
| Florida |
| 33024 |
| United States |
| NYU Langone Health | New York | New York | 10016 | 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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