A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers
NCT ID: NCT06116591
Last Updated: 2025-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2023-11-08
2024-05-27
Brief Summary
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All participants in this study will receive 2 doses of either mPnC candidate or mPnC control at the clinic approximately 8 weeks apart. All participants will also receive their third (toddler) dose of PCV10 at Visit 1.
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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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mPnC candidate
Participants will receive the mPnC candidate at Visit 1 and Visit 3 (approximately 8 weeks apart). PCV10 will also be given at Visit 1.
mPnC candidate
monovalent pneumococcal conjugate candidate
mPnC control
Participants will receive the mPnC control at Visit 1 and Visit 3 (approximately 8 weeks apart). PCV10 will also be given at Visit 1.
mPnC control
monovalent pneumococcal conjugate control
Interventions
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mPnC candidate
monovalent pneumococcal conjugate candidate
mPnC control
monovalent pneumococcal conjugate control
Eligibility Criteria
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Inclusion Criteria
* Have received exactly 2 infant doses of PCV10 according to a local immunization schedule.
* Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria
* significant neurological disorder or history of seizure (excluding febrile seizure) or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders.
* Major known congenital malformation or serious chronic disorder.
* History of microbiologically proven invasive disease caused by S pneumoniae.
* Previous vaccination with any licensed pneumococcal vaccine (other than the PCV10 primary infant series) or investigational pneumococcal vaccine, or planned receipt of nonstudy pneumococcal vaccine during study participation.
11 Months
15 Months
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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FVR, Kokkolan rokotetutkimusklinikka
Kokkola, Keski-Pohjanmaa, Finland
FVR, Oulun rokotetutkimusklinikka
Oulu, North Ostrobothnia, Finland
FVR, Tampereen rokotetutkimusklinikka
Tampere, Pirkanmaa, Finland
FVR, Seinäjoen rokotetutkimusklinikka
Seinäjoki, South Ostrobothnia, Finland
FVR, Turun rokotetutkimusklinikka
Turku, Southwest Finland, Finland
FVR, Espoon rokotetutkimusklinikka
Espoo, Uusimaa, Finland
FVR, Etelä-Helsingin rokotetutkimusklinikka
Helsinki, Uusimaa, Finland
MeVac - Meilahti Vaccine Research Center
Helsinki, Uusimaa, Finland
FVR, Järvenpään rokotetutkimusklinikka
Järvenpää, Uusimaa, Finland
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
NZOZ Praktyka Lekarza Rodzinnego "ESKULAP"
Lublin, Lublin Voivodeship, Poland
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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2023-505154-18-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4801002
Identifier Type: -
Identifier Source: org_study_id
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