Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
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ClinicalTrials.gov Identifier: NCT04887948 |
Recruitment Status :
Completed
First Posted : May 14, 2021
Last Update Posted : March 25, 2022
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Condition or disease | Intervention/treatment | Phase |
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Pneumococcal Disease COVID-19 SARS-CoV-2 Infection | Biological: 20-valent pneumococcal conjugate vaccine (20vPnC) Biological: BNT162b2 Other: Saline | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 570 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Triple |
Primary Purpose: | Prevention |
Official Title: | A PHASE 3, RANDOMIZED, DOUBLE BLIND TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF 20 VALENT PNEUMOCOCCAL CONJUGATE VACCINE WHEN COADMINISTERED WITH A BOOSTER DOSE OF BNT162b2 IN ADULTS 65 YEARS OF AGE AND OLDER |
Actual Study Start Date : | May 20, 2021 |
Actual Primary Completion Date : | December 8, 2021 |
Actual Study Completion Date : | December 8, 2021 |
Arm | Intervention/treatment |
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Experimental: Coadministration Group
Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit.
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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.
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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.
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Biological: BNT162b2
RNA-based SARS-CoV-2 vaccine (BNT162b2) Other: Saline Normal saline for injection |
- Percentage of participants reporting prompted local reactions within 10 days after vaccination [ Time Frame: 10 days ]Prompted local reactions (redness, swelling, pain) after vaccination
- Percentage of participants reporting prompted systemic events within 7 days after vaccination [ Time Frame: 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 [ Time Frame: 1 month ]Adverse events occurring within 1 month after vaccination
- Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination [ Time Frame: 6 months ]SAEs occurring within 6 months after vaccination
- Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) in participants vaccinated with 20vPnC [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 month after vaccination with BNT162b2 ]GMFR in SARS-CoV-2 full-length S-binding antibody levels from before to 1 month after BNT162b2

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887948

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT04887948 |
Other Study ID Numbers: |
B7471026 |
First Posted: | May 14, 2021 Key Record Dates |
Last Update Posted: | March 25, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Pneumococcal Infections Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |