Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
NCT ID: NCT05489328
Last Updated: 2024-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
394 participants
INTERVENTIONAL
2022-08-15
2022-10-07
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
NONE
Study Groups
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Candidate-1
Participants to receive a single injection of Candidate-1.
Candidate-1
Biological
Candidate-2
Participants to receive a single injection of Candidate-2.
Candidate-2
Biological
Candidate-3
Participants to receive a single injection of Candidate-3.
Candidate-3
Biological
Candidate-4
Participants to receive a single injection of Candidate-4.
Candidate-4
Biological
Candidate-5
Participants to receive a single injection of Candidate-5.
Candidate-5
Biological
Candidate-6
Participants to receive a single injection of Candidate-6.
Candidate-6
Biological
Candidate Control
Participants to receive a single injection of Candidate Control.
Candidate Control
Biological
13-valent pneumococcal conjugate vaccine (13vPnC)
Participants to receive a single injection of 13vPnC.
13vPnC
13-valent pneumococcal conjugate vaccine
15-valent pneumococcal conjugate vaccine (PCV15)
Participants to receive a single injection of PCV15.
PCV15
15-valent pneumococcal conjugate vaccine
Interventions
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Candidate-1
Biological
Candidate-2
Biological
Candidate-3
Biological
Candidate-4
Biological
Candidate-5
Biological
Candidate-6
Biological
Candidate Control
Biological
13vPnC
13-valent pneumococcal conjugate vaccine
PCV15
15-valent pneumococcal conjugate vaccine
Eligibility Criteria
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Inclusion Criteria
* Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
* Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children
Exclusion Criteria
* Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
* Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
* Known or suspected immunodeficiency or other conditions associated with immunosuppression
* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
* Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention
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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Orange County Research Center
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting
Milford, Connecticut, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Qps-Mra, Llc
South Miami, Florida, United States
Centennial Medical Group
Elkridge, Maryland, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, United States
Prism Research LLC dba Nucleus Network
Saint Paul, Minnesota, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
IMA Clinical Research San Antonio
San Antonio, Texas, United States
DM Clinical Research
Tomball, 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
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, United States
Countries
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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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C4801001
Identifier Type: -
Identifier Source: org_study_id
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