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| ID | Type | Description | Link |
|---|---|---|---|
| PISSARRO | Other Identifier | Alias Study Number |
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This purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coadministration Group | Other |
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| Sequential Administration Group | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) for RSV A and B in RSVpreF + herpes zoster subunit vaccine (HZ/su) Compared to RSVpreF Alone | 1 month after vaccination with RSVpreF in the RSVpreF + HZ/su coadministration group to RSVpreF alone in the sequential administration group | |
| Anti-gE antibody concentrations expressed as Geometric Mean Concentration (GMC) ratios in RSVpreF + HZ/su Compared to HZ/su Alone | 1 month after the second dose of HZ/su in the RSVpreF + HZ/su coadministration group to HZ/su alone in the sequential administration group | |
| Percentage of Participants reporting Local Reactions Within 7 Days after Vaccination | Describe local reactions (redness, swelling, and pain at the injection site) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary). | Within 7 Days after each vaccination (Vaccination on Day 1) |
| Percentage of Participants with Systemic Events Within 7 Days after Vaccination | Describe systemic events (fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary). | Within 7 Days after each vaccination (Vaccination on Day 1) |
| Percentage of Participants with Adverse Events (AEs)from Vaccination through 1 Month after Vaccination | Describe AEs occurring through 1 month after each study intervention administration | Within 1 Month after last vaccination |
| Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study | Describe SAEs occurring through 4 months after the first study intervention administration. |
| Measure | Description | Time Frame |
|---|---|---|
| NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT) | Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF | |
| NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR) | Before vaccination and 1 month after vaccination with RSVpreF |
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Inclusion Criteria
• Male and female participants 50 years of age and older who are healthy or with stable chronic medical conditions
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates | Birmingham | Alabama | 35205 | United States | ||
| Medical Affiliated Research Center |
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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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|
| HZ/su VACCINE | Biological | intramuscular injection |
|
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| Within 4 Months after first study vaccination (Vaccination on Day 1) |
| NTs for RSV A and RSV B expressed as seroresponse rate | 1 month after vaccination with RSVpreF |
| Anti-gE antibody concentrations expressed as GMCs | Before vaccination and 1 month after the second dose of HZ/su |
| Anti-gE antibody concentrations expressed as GMFRs | Before vaccination and 1 month after the second dose of HZ/su |
| Anti-gE antibody concentrations expressed as seroresponse rate | 1 month after the second dose of HZ/su |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| AMR Clinical | Mobile | Alabama | 36608 | United States |
| Kaiser Permanente | Los Angeles | California | 90027 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Alliance for Multispecialty Research, LLC | Doral | Florida | 33172 | United States |
| Proactive Clinical Research,LLC | Fort Lauderdale | Florida | 33308 | United States |
| De La Cruz Research Center, LLC | Miami | Florida | 33184 | United States |
| Centricity Research Columbus Georgia Multispecialty | Columbus | Georgia | 31904 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Synexus Clinical Research US, Inc. | Chicago | Illinois | 60602 | United States |
| Optimal Research | Peoria | Illinois | 61614 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| Jadestone Clinical Research | Silver Spring | Maryland | 20904 | United States |
| Oakland Medical Research | Troy | Michigan | 48085 | United States |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | United States |
| IMA Clinical Research Warren | Warren Township | New Jersey | 07059 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Centricity Research Columbus Ohio Multispecialty | Columbus | Ohio | 43213 | United States |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Clinical Neuroscience Solutions Inc. | Memphis | Tennessee | 38119 | United States |
| DM Clinical Research - Bellaire | Houston | Texas | 77081 | United States |
| SMS Clinical Research | Mesquite | Texas | 75149 | United States |
| IMA Clinical Research San Antonio | San Antonio | Texas | 78229 | United States |
| DM Clinical Research - Sugar Land | Sugar Land | Texas | 77478 | United States |
| Clinical Research Puerto Rico | San Juan | 00909 | Puerto Rico |
| ID | Term |
|---|---|
| C000729228 | abrysvo |
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