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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06182124 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn about the safety and immune effects of a pneumococcal vaccine in adults. This vaccine can possibly provide protection against further pneumococcal disease.
This study will happen in 4 stages: Stage 1 is seeking participants who are between 18 years to 49 years of age. The participants will receive 1 of 2 pneumococcal vaccine candidates (different formulations) or 20vPnC (Prevnar 20) as a single shot given into the upper arm muscle.
Stage 2 will begin after participants have completed Stage 1, and a pneumococcal vaccine candidate has been decided.
Stage 2 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or 20vPnC (Prevnar 20). The vaccines will be given as a single shot into the upper arm muscle.
Stage 3 is seeking participants who are adults 50 years of age and older. The participants will receive the chosen pneumococcal vaccine candidate from Stage 1 or a licensed pneumococcal comparator vaccine. The vaccines will be given as a single shot into the upper arm muscle.
Stage 4 is seeking participants who are adults 50 years of age and older. The participants will receive either one of three pneumococcal vaccine candidates or one of two licensed pneumococcal comparator vaccines. The vaccines will be given as a single shot into the upper arm muscle.
Participants will take part in this study for about 6 months for Stage 1, Stage 3, and Stage 4 and 12 months for Stage 2. During this time participants will have from 2 to 4 clinic visits and 1 phone visit. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during these clinic visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1 | Experimental | Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
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| Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2 | Experimental | Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
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| Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC) | Active Comparator | Participants to receive a single injection of 20vPnC. |
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| Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine | Active Comparator | Participants to receive a single injection of a licensed pneumococcal comparator vaccine. |
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| Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivalent Pneumococcal Vaccine - Formulation 1 | Biological | Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting prespecified local reactions within 7 days after vaccination | Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination | 7 days |
| Percentage of participants reporting prespecified systemic events within 7 days after vaccination | Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination | 7 days |
| Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination | Adverse events occurring within 1 month after vaccination | 1 month |
| Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination | SAEs occurring within 6 months after vaccination | 6 months |
| Phase 2 (Stage 2) Only: Percentage of participants reporting related Serious Adverse Events (SAEs) through 12 months after vaccination | Related SAEs occurring through 12 months after vaccination | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 (Stage 1) and Phase 2 (Stage 2) Only: Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) | Pneumococcal OPA GMTs 1 month after vaccination | 1 month after vaccination |
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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 |
|---|---|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC | Doral | Florida | 33172 | United States | ||
| Indago Research & Health Center, Inc |
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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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Parallel Assignment
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Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3. |
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| Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4 | Experimental | Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4. |
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| Multivalent Pneumococcal Vaccine - Formulation 2 | Biological | Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
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| 20-valent pneumococcal conjugate vaccine (20vPnC) | Biological | 20-valent pneumococcal conjugate vaccine (20vPnC) |
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| Licensed pneumococcal comparator vaccine | Biological | A licensed pneumococcal comparator vaccine |
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| Multivalent Pneumococcal Vaccine - Formulation 3 | Biological | Multivalent pneumococcal conjugate vaccine |
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| Multivalent Pneumococcal Vaccine - Formulation 4 | Biological | Multivalent pneumococcal conjugate vaccine |
|
| Hialeah |
| Florida |
| 33012 |
| United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Optimal Research | Peoria | Illinois | 61614 | United States |
| Alliance for Multispecialty Research, LLC | New Orleans | Louisiana | 70119 | United States |
| Headlands Research - Detroit | Southfield | Michigan | 48034 | United States |
| Rochester Clinical Research, LLC | Rochester | New York | 14609 | United States |
| IMA Evaluations, LLC dba IMA Clinical Research | Tarrytown | New York | 10591 | United States |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | United States |
| AMR Clinical | Knoxville | Tennessee | 37909 | United States |
| AMR Clinical | Knoxville | Tennessee | 37920 | United States |
| Headlands Horizons LLC | Brownsville | Texas | 78526 | United States |
| DM Clinical Research- Cyfair | Houston | Texas | 77065 | United States |
| Clinical Trials of Texas, LLC dba Flourish Research | San Antonio | Texas | 78229 | United States |
| IMA Clinical Research San Antonio | San Antonio | Texas | 78229 | United States |
| Dynamed Clinical Research, LP d/b/a DM Clinical Research | Sugar Land | Texas | 77478 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Dynamed Clinical Research, LP d/b/a DM Clinical Research | Tomball | Texas | 77375 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Inc. | Salt Lake City | Utah | 84109 | United States |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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