A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
NCT ID: NCT03313050
Last Updated: 2020-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
511 participants
INTERVENTIONAL
2017-10-12
2019-05-24
Brief Summary
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In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).
In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Stage 1 multivalent (ages 50-64 years)
multivalent
Multivalent
Pneumococcal conjugate vaccine
Stage 1 Tdap (ages 50-64 years)
Tdap
Tdap
Tetanus, diphtheria, acellular pertussis vaccine
Stage 2 multivalent (ages 65-85 years)
multivalent
Multivalent
Pneumococcal conjugate vaccine
Stage 2 polysaccharide (ages 65-85 years)
polysaccharide
polysaccharide
23-valent pneumococcal polysaccharide vaccine
Interventions
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Multivalent
Pneumococcal conjugate vaccine
Tdap
Tetanus, diphtheria, acellular pertussis vaccine
polysaccharide
23-valent pneumococcal polysaccharide vaccine
Eligibility Criteria
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Inclusion Criteria
* Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>= 2 months prior to investigational product administration
Exclusion Criteria
* Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13
50 Years
85 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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Achieve Clinical Research LLC
Birmingham, Alabama, United States
Core Healthcare Group
Cerritos, California, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Augusta Family Practice
Augusta, Kansas, United States
Heartland Research Associates, LLC
Augusta, Kansas, 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
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Meridian Clinical Research LLC
Omaha, Nebraska, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Omega Medical Research
Warwick, Rhode Island, United States
Medical Research South, LLC
Goose Creek, South Carolina, United States
J. Lewis Research Incorporated, Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Incorporated/Foothill Family Clinic South
Salt Lake City, Utah, United States
Advanced Clinical Research
West Jordan, Utah, United States
Countries
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References
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Essink B, Peterson J, Yacisin K, Lal H, Mirza S, Xu X, Scully IL, Scott DA, Gruber WC, Jansen KU, Watson W. A randomized phase 1/2 study of the safety and immunogenicity of a multivalent pneumococcal conjugate vaccine in healthy adults 50 through 85 years of age. Hum Vaccin Immunother. 2021 Aug 3;17(8):2691-2699. doi: 10.1080/21645515.2021.1890511. Epub 2021 Mar 4.
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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C3571001
Identifier Type: -
Identifier Source: org_study_id
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