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

Purpose

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

Conditions

  • Pneumococcal Disease
  • COVID-19
  • SARS-CoV-2 Infection

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Triple

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04887948
Status
Completed
Sponsor
Pfizer