Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2

Pfizer

Status and phase: Completed; Phase 3

Conditions: COVID-19; SARS-CoV-2 Infection; Pneumococcal Disease

Treatments: Biological: 20-valent pneumococcal conjugate vaccine (20vPnC); Biological: BNT162b2; Other: Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT04887948

B7471026

Details and patient eligibility

About

Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone

Enrollment: 570 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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570 participants in 3 patient groups

Coadministration Group

Experimental group

Description:

Participants receive an injection of pneumococcal vaccine (20vPnC) and of COVID-19 vaccine (BNT162b2) at the same visit.

Treatment:

Biological: BNT162b2

Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)

20vPnC-only Group

Active Comparator group

Description:

Participants receive an injection of pneumococcal vaccine (20vPnC) and of saline at the same visit.

Treatment:

Other: Saline

Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)

BNT162b2-only Group

Active Comparator group

Description:

Participants receive an injection of COVID-19 vaccine (BNT162b2) and of saline at the same visit.

Treatment:

Biological: BNT162b2

Other: Saline