Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
NCT ID: NCT03828617
Last Updated: 2020-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1710 participants
INTERVENTIONAL
2019-02-14
2019-10-09
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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20vPnC Lot 1
20vPnC Lot 1
20vPnC
20vPnC
20vPnC Lot 2
20vPnC Lot 2
20vPnC
20vPnC
20vPnC Lot 3
20vPnC Lot 3
20vPnC
20vPnC
13vPnC
13vPnC
13vPnC
Pneumococcal conjugate vaccine
Interventions
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20vPnC
20vPnC
20vPnC
20vPnC
20vPnC
20vPnC
13vPnC
Pneumococcal conjugate vaccine
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. Female subject of childbearing potential or male subject who is able to father children, and willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the dose of investigational product; or female subject not of childbearing potential or male subject not able to father children.
Exclusion Criteria
2. 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.
3. History of microbiologically proven invasive disease caused by S pneumoniae.
4. Pregnant female subjects or breastfeeding female subjects (known or suspected).
18 Years
49 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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Anaheim Clinical Trials, LLC
Anaheim, California, United States
Kaiser Permanente Sacramento
Sacramento, California, United States
Kaiser Permanente South Sacramento
Sacramento, California, United States
Kaiser Permanente San Jose
San Jose, California, United States
Kaiser Permanente Santa Clara
Santa Clara, California, United States
Accel Research Sites - Clinical Research Unit
DeLand, Florida, United States
Research Centers of America, LLC
Hollywood, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East West Medical Research Institute
Honolulu, Hawaii, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Omega Medical Research
Warwick, Rhode Island, United States
Meridian Clinical Research, LLC
Dakota Dunes, South Dakota, United States
Benchmark Research
Austin, Texas, 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
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.
Klein NP, Peyrani P, Yacisin K, Caldwell N, Xu X, Scully IL, Scott DA, Jansen KU, Gruber WC, Watson W. A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age. Vaccine. 2021 Sep 7;39(38):5428-5435. doi: 10.1016/j.vaccine.2021.07.004. Epub 2021 Jul 24.
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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B7471008
Identifier Type: -
Identifier Source: org_study_id