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The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults.
Participants will receive either:
Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up visits.
At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during clinic visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PG4 vaccine with low dose adjuvant PA-001; dose schedule 1 | Experimental |
| |
| PG4 vaccine with low dose adjuvant PA-001; dose schedule 2 | Experimental |
| |
| PG4 vaccine with low dose adjuvant PA-002; dose schedule 1 | Experimental |
| |
| PG4 vaccine with low dose adjuvant PA-002; dose schedule 2 | Experimental |
| |
| PG4 vaccine with high dose adjuvant PA-001; dose schedule 1 | Experimental |
| |
| PG4 vaccine with high dose adjuvant PA-001; dose schedule 2 | Experimental |
| |
| PG4 vaccine with high dose adjuvant PA-002; dose schedule 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG4 vaccine in Buffer 1 with low dose PA-001 | Biological | Multivalent pneumococcal conjugate vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting prespecified local reactions after each dose. | Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study. | Within 7 days after each study intervention. |
| Percentage of participants reporting prespecified systemic reactions after each dose. | Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study. | Within 7 days after each study intervention. |
| Percentage of participants reporting adverse events. | Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination | From signing of the ICD to 1 month after last study intervention. |
| Percentage of participants reporting serious adverse events. | Serious Adverse Events (SAEs) occurring from Dose 1 through 6 months after the last vaccination. | From signing of the ICD to 6 months after the last study intervention. |
| Percentage of participants reporting serious adverse events. | Serious Adverse Events (SAEs) occurring from Dose 1 through 12 months after the last vaccination. | From signing of the ICD to 12 months after the last study intervention. |
| Percentage of participants with abnormal hematology and chemistry laboratory values. | Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
• Participants with a history of microbiologically proven invasive disease caused by S pneumoniae.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Lake Forest | California | 92630 | United States | ||
| Peninsula Research Associates |
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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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| Experimental |
|
| PG4 vaccine with high dose adjuvant PA-002; dose schedule 2 | Experimental |
|
| PG4 vaccine; dose schedule 1 | Active Comparator |
|
| PG4 vaccine; dose schedule 2 | Active Comparator |
|
| 20vPnC; dose schedule 1 | Active Comparator |
|
| 20vPnC; dose schedule 2 | Active Comparator |
|
| PG4 in Buffer 1 with low dose PA-002 | Biological | Multivalent pneumococcal conjugate vaccine |
|
| PG4 in Buffer 1 with high dose PA-001 | Biological | Multivalent pneumococcal conjugate vaccine |
|
| PG4 vaccine in Buffer 1 with high dose PA-002 | Biological | Multivalent pneumococcal conjugate vaccine |
|
| PG4 vaccine in Buffer 2 | Biological | Multivalent pneumococcal conjugate vaccine |
|
| 20-valent pneumococcal conjugate vaccine | Biological | (20vPnC) |
|
| Saline injection | Biological | Placebo |
|
| Within 2 weeks after each study intervention. |
| Rolling Hills Estates |
| California |
| 90274 |
| United States |
| Finlay Medical Research | Greenacres City | Florida | 33467 | United States |
| Indago Research & Health Center, Inc. | Miami Lakes | Florida | 33016 | United States |
| Johnson County Clinical Trials | Lenexa | Kansas | 66219 | 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 |
| Bio-Kinetic Clinical Applications, LLC dba QPS-MO | Springfield | Missouri | 65807 | United States |
| Velocity Clinical Research, Omaha | Omaha | Nebraska | 68134 | United States |
| Upstate Global Health Institute | East Syracuse | New York | 13057 | United States |
| NYU Langone Health Vaccine Center | New York | New York | 10016 | United States |
| Duke Vaccine and Trials Unit | Durham | North Carolina | 27703 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| Headlands Horizons, LLC dba Headlands Research-Brownsville | Brownsville | Texas | 78526 | United States |
| Valley Regional Medical Center | Brownsville | Texas | 78526 | United States |
| LabCorp | Houston | Texas | 77064 | United States |
| IMA Clinical Research San Antonio | San Antonio | Texas | 78229 | 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. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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