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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19.
This study is seeking participants 12 through 64 years of age who are considered to be at higher risk for severe COVID-19 disease per study protocol and those 65 years of age and older. All participants in this study will receive 1 shot to their arm of a BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg RNA-based vaccine which targets a circulating variant of SARS-CoV-2 and is selected for the 2025-2026 COVID-19 respiratory virus season. This study is about 6 months for each participant. Participants will either be enrolled in Cohort 1 (Groups 1 and 2) or Cohort 2 (Groups 3 and 4). Participants enrolled in Cohort 1 will have at least 4 visits and participants enrolled in Cohort 2 will have at least 3 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 18 through 64 years of age (higher-risk individuals) | Experimental | Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 |
|
| Group 2: 65 years of age and older | Experimental | Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 |
|
| Group 3: 12 through 64 years of age (higher-risk individuals) | Experimental | Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 |
|
| Group 4: 65 years of age and older | Experimental | Participants will receive BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) 30 µg at Visit 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b2 (2025/2026 recommended SARS-CoV-2 strain) | Biological | BNT162b2 monovalent (2025/2026 recommended SARS-CoV-2 strain) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting local reactions | For up to 7 days after vaccination | |
| Percentage of participants reporting systemic events | For up to 7 days after vaccination | |
| Percentage of participants reporting adverse events | Through 1 month after vaccination | |
| Percentage of participants reporting serious adverse events | Through 6 months after vaccination | |
| Cohort 1: Geometric Mean Titers (GMTs) | At 2 weeks after vaccination | |
| Cohort 1: Geometric Mean Fold Rises (GMFRs) | From before vaccination to 2 weeks after vaccination | |
| Cohort 1: Percentages of participants with seroresponse | 2 weeks after vaccination | |
| Cohort 2: Geometric Mean Fold Rises (GMFRs) | From before vaccination to 1 month after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Geometric Mean Titers (GMTs) | At 1 month after vaccination | |
| Cohort 1: Geometric Mean Fold Rises (GMFRs) | From before vaccination to 1 month after vaccination | |
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Inclusion criteria:
Exclusion Criteria:
Refer to the study contact for further eligibility details.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States | ||
| Clinical Research Consulting |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42042826 | Derived | Dadhe R, Gayed J, Iqbal M, Solan R, Wu H, Ma H, Xu X, Mensa FJ, Belanger T, Cooper D, Mogg R, Anderson AS, Tureci O, Sahin U, Allen PS, Modjarrad K, Gurtman A, Lindert K. A Study to Investigate the Safety and Immunogenicity of Monovalent Omicron LP.8.1-Adapted BNT162b2 COVID-19 Vaccine in Adults >/= 65 Years of Age and High-Risk Adults 18-64 Years of Age (Preliminary Results). Vaccines (Basel). 2026 Apr 15;14(4):350. doi: 10.3390/vaccines14040350. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Cohort 1: Percentages of participants with seroresponse |
| 1 month after vaccination |
| Cohort 2: Geometric Mean Titers (GMTs) | From before vaccination to 1 month after vaccination |
| Cohort 2: Percentages of participants with seroresponse | 1 month after vaccination |
| Milford |
| Connecticut |
| 06460 |
| United States |
| GW Vaccine Research Unit | Washington D.C. | District of Columbia | 20037 | United States |
| The GW Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| Indago Research & Health Center, Inc | Hialeah | Florida | 33012 | United States |
| Palm Springs Community Health Center | Miami Lakes | Florida | 33014 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | United States |
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO | Springfield | Missouri | 65802 | United States |
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center | Springfield | Missouri | 65807 | United States |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | United States |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Senders Pediatrics | South Euclid | Ohio | 44121 | United States |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| DM Clinical Research- Cyfair | Houston | Texas | 77065 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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