Status:
COMPLETED
A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers
Lead Sponsor:
Pfizer
Conditions:
Healthy Participants
Eligibility:
All Genders
11-15 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to learn about the effects of a monovalent (single component) pneumococcal conjugate candidate (mPnC candidate) when given to toddlers between 11 and 15 months of age. All...
Eligibility Criteria
Inclusion
- Key
- Toddlers ≥11 to ≤15 months of age at the time of consent.
- 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.
- Key
Exclusion
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of study intervention, 13vPnC, 20vPnC, or any diphtheria toxoid-containing vaccine.
- 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.
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2024
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT06116591
Start Date
November 8 2023
End Date
May 27 2024
Last Update
May 8 2025
Active Locations (11)
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1
FVR, Kokkolan rokotetutkimusklinikka
Kokkola, Keski-Pohjanmaa, Finland, 67100
2
FVR, Oulun rokotetutkimusklinikka
Oulu, North Ostrobothnia, Finland, 90220
3
FVR, Tampereen rokotetutkimusklinikka
Tampere, Pirkanmaa, Finland, 33100
4
FVR, Seinäjoen rokotetutkimusklinikka
Seinäjoki, South Ostrobothnia, Finland, 60100