Clinical trial NCT03760146: Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 YEARS OF AGE AND OLDER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-11-30
Enrollment: 3902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults


Eligibility criteria: Inclusion Criteria:

1. Male or female adults \>/= 18 years of age (from the 18th birthday) at enrollment and older.
2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
3. Negative urine pregnancy test at Visit1 for all subjects who are of childbearing potential.

Exclusion Criteria:

1. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
2. History of microbiologically proven invasive disease caused by S pneumoniae.
3. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
4. Pregnant female subjects or breastfeeding female subjects.

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 10 Days After Vaccination in All Cohorts
timeFrame: Within 10 days after 20vPnC or 13vPnC
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination in All Cohorts
timeFrame: Within 7 days after 20vPnC or 13vPnC
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination in All Cohorts
timeFrame: Within 1 month after 20vPnC or 13vPnC
measure: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination in All Cohorts
timeFrame: Within 6 months after 20vPnC or 13vPnC
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination in All Cohorts
timeFrame: Within 6 months after 20vPnC or 13vPnC
measure: Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
timeFrame: 1 month after Vaccination 1
measure: Pneumococcal OPA GMTs for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population (E7-AIP)
timeFrame: 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline"; 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"
Secondary outcomes:
measure: Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 2, 50 Through 59 Years of Age and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
timeFrame: 1 month after vaccination
measure: Pneumococcal OPA GMTs for the 20 Vaccines Serotypes at 1 Month After 20vPnC Vaccination in Cohort 3, 18 Through 49 Years and Cohort 1, Only 60 Through 64 Years of Age: Evaluable-20 Immunogenicity Population
timeFrame: 1 month after vaccination
measure: Pneumococcal OPA Geometric Mean Fold Rises (GMFRs) for the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
timeFrame: Before Vaccination 1 to 1 month after Vaccination 1
measure: Pneumococcal OPA GMFRs for the Additional 7 Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
timeFrame: From before Vaccination 1 to 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or From before Vaccination 1 to 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"
measure: Pneumococcal OPA GMFRs for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
timeFrame: Before vaccination to 1 month after vaccination
measure: Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers to the 13 Matched Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
timeFrame: Before Vaccination 1 to 1 month after Vaccination 1
measure: Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 7 Additional Serotypes From Before Vaccination 1 to 1 Month After Vaccination 1(20vPnC) or From Before Vaccination 1 to 1 Month After Vaccination 2(PPSV23) in Cohort 1:E7-AIP
timeFrame: Before Vaccination 1 to 1 month after Vaccination 1 for "Cohort 1: 20vPnC/Saline"; Before Vaccination 1 to 1 month after Vaccination 2 for "Cohort 1: 13vPnC/PPSV23"
measure: Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers for the 20 Vaccines Serotypes From Before Vaccination to 1 Month After Vaccination in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
timeFrame: Before vaccination to 1 month after vaccination
measure: Percentage of Participants With Pneumococcal OPA Titers >= Lower Limit of Quantitation (LLOQ) for the 13 Matched Serotypes at 1 Month After Vaccination 1 (20vPnC or 13vPnC) in Cohort 1: Evaluable 13-Matched Immunogenicity Population
timeFrame: 1 month after Vaccination 1
measure: Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 7 Additional Serotypes at 1 Month After Vaccination 1 (20vPnC) or 1 Month After Vaccination 2 (PPSV23) in Cohort 1: Evaluable 7-Additional Immunogenicity Population
timeFrame: 1 month after Vaccination 1 in "Cohort 1: 20vPnC/Saline" or 1 month after Vaccination 2 in "Cohort 1: 13vPnC/PPSV23"
measure: Percentage of Participants With Pneumococcal OPA Titers >=LLOQ for the 20 Vaccines Serotypes at 1 Month After Vaccination (20vPnC) in Cohort 2 and 3: Evaluable-20 Immunogenicity Population
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Sites
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Chandler
country: United States
facility: East Valley Gastroenterology and Hepatology Associates
state: Arizona
city: Peoria
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: MedPharmics, LLC
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
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: Milford
country: United States
facility: Clinical Research Consulting, LLC
state: Connecticut
city: Crystal River
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites - Clinical Research Unit
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America, LLC
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates
state: Florida
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research LLC
state: Georgia
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: Newton
country: United States
facility: Axtell Clinic, P.A.
state: Kansas
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Northwest Family Physicians
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Rockville
country: United States
facility: Meridian Clinical Research, LLC
state: Maryland
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Norfolk
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research LLC
state: Nebraska
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, Inc.
state: New Hampshire
city: Binghamton
country: United States
facility: United Medical Associates
state: New York
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center (CCHMC)
state: Ohio
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd.
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research, LLC
state: South Dakota
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Bellaire
country: United States
facility: Bellaire Doctor's Clinic
state: Texas
city: Fort Worth
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: HealthFirst Medical Group
state: Texas
city: Keller
country: United States
facility: Ventavia Research Group, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Spring
country: United States
facility: Ventavia Research Group, LLC
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: Draper
country: United States
facility: J. Lewis Research Inc. / Foothill Family Clinic Draper
state: Utah
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: South Jordan
country: United States
facility: J. Lewis Research, Inc. - Jordan River Family Medicine
state: Utah
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
city: Boras
country: Sweden
facility: Ladulaas Kliniska Studier
city: Eskilstuna
country: Sweden
facility: Infektionskliniken Malarsjukhuset
city: Lund
country: Sweden
facility: ProbarE i Lund
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance, KTA Prim
city: Stockholm
country: Sweden
facility: Akardo Med Site
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Örebro
country: Sweden
facility: Avdelningen för kliniska prövningar
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Sabharwal C, Sundaraiyer V, Peng Y, Moyer L, Belanger TJ, Gessner BD, Jodar L, Jansen KU, Gruber WC, Scott DA, Watson W. Immunogenicity of a 20-valent pneumococcal conjugate vaccine in adults 18 to 64 years old with medical conditions and other factors that increase risk of pneumococcal disease. Hum Vaccin Immunother. 2022 Nov 30;18(6):2126253. doi: 10.1080/21645515.2022.2126253. Epub 2022 Nov 11.
citation: Essink B, Sabharwal C, Cannon K, Frenck R, Lal H, Xu X, Sundaraiyer V, Peng Y, Moyer L, Pride MW, Scully IL, Jansen KU, Gruber WC, Scott DA, Watson W. Pivotal Phase 3 Randomized Clinical Trial of the Safety, Tolerability, and Immunogenicity of 20-Valent Pneumococcal Conjugate Vaccine in Adults Aged >/=18 Years. Clin Infect Dis. 2022 Aug 31;75(3):390-398. doi: 10.1093/cid/ciab990.
citation: Mt-Isa S, Abderhalden LA, Musey L, Weiss T. Matching-adjusted indirect comparison of pneumococcal vaccines V114 and PCV20. Expert Rev Vaccines. 2022 Jan;21(1):115-123. doi: 10.1080/14760584.2021.1994858. Epub 2021 Oct 27.
citation: Perdrizet J, Santana CFS, Senna T, Alexandre RF, Sini de Almeida R, Spinardi J, Wasserman M. Cost-effectiveness analysis of replacing the 10-valent pneumococcal conjugate vaccine (PCV10) with the 13-valent pneumococcal conjugate vaccine (PCV13) in Brazil infants. Hum Vaccin Immunother. 2021 Apr 3;17(4):1162-1172. doi: 10.1080/21645515.2020.1809266. Epub 2020 Sep 23.