Clinical trial NCT04887948: Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
COVID-19
SARS-CoV-2 Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-05-14
Enrollment: 570
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Percentage of Participants With Local Reactions at Each Injection Site Within 10 Days After Vaccination
timeFrame: Within 10 days after vaccination
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
timeFrame: Within 7 days after vaccination
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
timeFrame: From day of vaccination (Day 1) up to 1 month after vaccination
measure: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
timeFrame: From day of vaccination (Day 1) up to 6 months after vaccination
Secondary outcomes:
measure: Geometric Mean Titers (GMTs) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) at 1 Month After Vaccination With 20vPnC
timeFrame: 1 month after vaccination with 20vPnC
measure: Geometric Mean Concentration (GMC) of Full-Length S-Binding Immunoglobulin G (IgG) Levels at 1 Month After Vaccination With BNT162b2
timeFrame: 1 month after vaccination with BNT162b2
measure: Geometric Mean Fold Rise (GMFR) of Full-Length S-Binding IgG Levels From Before Vaccination to 1 Month After Vaccination With BNT162b2
timeFrame: Before vaccination to 1 month after vaccination with BNT162b2
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America ( Hollywood )
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Endwell
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research San Antonio
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Tomball
country: United States
facility: Martins Diagnostic Clinic
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: