Phase 3
Completed N=570
Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
Pneumococcal Disease · COVID-19 · SARS-CoV-2 Infection
Source: ClinicalTrials.gov NCT04887948 ↗
Enrolled (actual)
570
Serious AEs
1.4%
Results posted
Dec 2022
Primary outcomePrimary: Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination — 8.6; 9.7; 8.1; 0.0 Percentage of participants
◆ Published Evidence
Established
26citations · ~9 / year
Randomized trial to evaluate the safety, tolerability, and immunogenicity of a booster (third dose) of BNT162b2 COVID-19 vaccine coadministered with 20-valent pneumococcal conjugate vaccine in adults ≥65 years old.
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
Linked Publications
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Randomized trial to evaluate the safety, tolerability, and immunogenicity of a booster (third dose) of BNT162b2 COVID-19 vaccine coadministered with 20-valent pneumococcal conjugate vaccine in adults ≥65 years old.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination |
8.6; 9.7; 8.1; 0.0; 9.7; 2.7 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Vaccination |
13.0; 1.1; 8.6; 7.0; 0.5; 2.7 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination |
5.3; 4.3; 6.5 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination |
0.5; 1.1; 2.7 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC |
142; 131; 49; 52; 609; 573 | — |
| SECONDARY Geometric Mean Concentration (GMC) of Full-Length S-Binding Immunoglobulin G (IgG) Levels at 1 Month After Vaccination With BNT162b2 |
29114; 26655 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of Full-Length S-Binding IgG Levels From Before Vaccination to 1 Month After Vaccination With BNT162b2 |
35.5; 39.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04887948) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.