Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adults
NCT ID: NCT03760146
Last Updated: 2021-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3902 participants
INTERVENTIONAL
2018-12-12
2019-12-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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60 years and above 20vPnC/Saline
20vPnC and saline
20vPnC
20vPnC
Saline
Placebo
60 years and above 13vPnC/PPSV23
13vPnC and PPSV23
13vPnC
Pneumococcal conjugate vaccine
PPSV23
Pneumococcal polysaccharide vaccine
50 through 59 years of age 20vPnC
20vPnC
20vPnC
20vPnC
18 through 49 years of age 20vPnC
20vPnC
20vPnC
20vPnC
50 through 59 years of age 13vPnC
13vPnC
13vPnC
Pneumococcal conjugate vaccine
18 through 49 years of age 13vPnC
13vPnC
13vPnC
Pneumococcal conjugate vaccine
Interventions
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20vPnC
20vPnC
13vPnC
Pneumococcal conjugate vaccine
PPSV23
Pneumococcal polysaccharide vaccine
Saline
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Accel Research Sites
Birmingham, Alabama, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona, United States
The Pain Center of Arizona
Peoria, Arizona, United States
MedPharmics, LLC
Phoenix, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
The Pain Center of Arizona
Phoenix, Arizona, United States
Anaheim Clinical Trials, LLC
Anaheim, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting, LLC
Milford, Connecticut, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
Accel Research Sites - Clinical Research Unit
DeLand, Florida, United States
Research Centers of America, LLC
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Suncoast Research Group, LLC
Miami, Florida, United States
Acevedo Clinical Research Associates
Miami, Florida, United States
Qps-Mra, Llc
South Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Meridian Clinical Research LLC
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Axtell Clinic, P.A.
Newton, Kansas, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Northwest Family Physicians
Wichita, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Meridian Clinical Research, LLC
Rockville, Maryland, United States
Sundance Clinical Research
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Meridian Clinical Research LLC
Omaha, Nebraska, United States
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, United States
United Medical Associates
Binghamton, New York, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
PharmQuest
Greensboro, North Carolina, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center (CCHMC)
Cincinnati, Ohio, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Omega Medical Research
Warwick, Rhode Island, United States
Meridian Clinical Research, LLC
Dakota Dunes, South Dakota, United States
Tekton Research, Inc.
Austin, Texas, United States
Bellaire Doctor's Clinic
Bellaire, Texas, United States
Ventavia Research Group, LLC
Fort Worth, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
HealthFirst Medical Group
Fort Worth, Texas, United States
Ventavia Research Group, LLC
Keller, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Ventavia Research Group, LLC
Spring, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
J. Lewis Research, Inc. - Jordan River Family Medicine
South Jordan, Utah, United States
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States
Ladulaas Kliniska Studier
Borås, , Sweden
Infektionskliniken Malarsjukhuset
Eskilstuna, , Sweden
ProbarE i Lund
Lund, , Sweden
Avdelningen för kliniska prövningar
Örebro, , Sweden
Karolinska Trial Alliance, KTA Prim
Stockholm, , Sweden
Akardo Med Site
Stockholm, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2018-004279-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7471007
Identifier Type: -
Identifier Source: org_study_id