Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
Study Details
Study Description
Brief Summary
Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Coadministration Group Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit. |
Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Biological: BNT162b2
RNA-based SARS-CoV-2 vaccine (BNT162b2)
|
| Active Comparator: 20vPnC-only Group Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit. |
Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Other: Saline
Normal saline for injection
|
| Active Comparator: BNT162b2-only Group Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit. |
Biological: BNT162b2
RNA-based SARS-CoV-2 vaccine (BNT162b2)
Other: Saline
Normal saline for injection
|
Outcome Measures
Primary Outcome Measures
- Percentage of participants reporting prompted local reactions within 10 days after vaccination [10 days]
Prompted local reactions (redness, swelling, pain) after vaccination
- Percentage of participants reporting prompted systemic events within 7 days after vaccination [7 days]
Prompted systemic events (fever, headache, chills, fatigue, muscle pain, joint pain) after vaccination
- Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination [1 month]
Adverse events occurring within 1 month after vaccination
- Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination [6 months]
SAEs occurring within 6 months after vaccination
Secondary Outcome Measures
- Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) in participants vaccinated with 20vPnC [1 month after vaccination with 20vPnC]
Pneumococcal OPA GMTs 1 month after 20vPnC
- Geometric mean concentration (GMC) of SARS-CoV-2 full-length S-binding antibody levels in participants vaccinated with BNT162b2 [1 month after vaccination with BNT162b2]
SARS-CoV-2 full-length S-binding antibody levels 1 month after BNT162b2
- Geometric mean fold-rise (GMFR) in SARS-CoV-2 full-length S-binding antibody levels from before vaccination to 1 month after vaccination in participants vaccinated with BNT162b2 [1 month after vaccination with BNT162b2]
GMFR in SARS-CoV-2 full-length S-binding antibody levels from before to 1 month after BNT162b2
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female participants ≥65 years of age at the time of consent
-
Participating or participated in Study C4591001, received 2 doses of 30 µg BNT162b2 with the second dose given ≥6 months prior to the first vaccination in this study, and have not received a third dose of BNT162b2
-
Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with preexisting stable disease
-
Adults who have no history of ever receiving a pneumococcal vaccine, or received a licensed pneumococcal vaccination ≥12 months prior to the first vaccination in this study
Exclusion Criteria:
-
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
-
Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
-
Previous clinical or microbiological diagnosis of COVID-19
-
Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
-
Previous vaccination with any coronavirus vaccine, other than those received in Study C4591001
-
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anaheim Clinical Trials, LLC | Anaheim | California | United States | 92801 |
| 2 | Diablo Clinical Research, Inc. | Walnut Creek | California | United States | 94598 |
| 3 | Alliance for Multispecialty Research, LLC | Coral Gables | Florida | United States | 33134 |
| 4 | Indago Research & Health Center, Inc. | Hialeah | Florida | United States | 33012 |
| 5 | Indago Research & Health Center, Inc | Hialeah | Florida | United States | 33012 |
| 6 | Research Centers of America ( Hollywood ) | Hollywood | Florida | United States | 33024 |
| 7 | Acevedo Clinical Research Associates | Miami | Florida | United States | 33142 |
| 8 | Clinical Neuroscience Solutions | Orlando | Florida | United States | 32801 |
| 9 | Clinical Research Atlanta | Stockbridge | Georgia | United States | 30281 |
| 10 | East-West Medical Research Institute | Honolulu | Hawaii | United States | 96814 |
| 11 | Solaris Clinical Research | Meridian | Idaho | United States | 83646 |
| 12 | Alliance for Multispecialty Research, LLC | Newton | Kansas | United States | 67114 |
| 13 | Clinical Research Professionals | Chesterfield | Missouri | United States | 63005 |
| 14 | Sundance Clinical Research | Saint Louis | Missouri | United States | 63141 |
| 15 | Meridian Clinical Research, LLC | Omaha | Nebraska | United States | 68134 |
| 16 | Meridian Clinical Research, LLC | Endwell | New York | United States | 13760 |
| 17 | Accellacare - Wilmington | Wilmington | North Carolina | United States | 28401 |
| 18 | Aventiv Research Inc | Columbus | Ohio | United States | 43213 |
| 19 | Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | United States | 37909 |
| 20 | Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Memphis | Tennessee | United States | 38119 |
| 21 | Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | United States | 38119 |
| 22 | Benchmark Research | Austin | Texas | United States | 78705 |
| 23 | Diagnostics Research Group | San Antonio | Texas | United States | 78229 |
| 24 | DM Clinical Research | Tomball | Texas | United States | 77375 |
| 25 | Martin Diagnostic Clinic | Tomball | Texas | United States | 77375 |
| 26 | Martins Diagnostic Clinic | Tomball | Texas | United States | 77375 |
| 27 | J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | United States | 84109 |
| 28 | J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | United States | 84121 |
| 29 | Wenatchee Valley Hospital | Wenatchee | Washington | United States | 98801 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- B7471026