Status:
COMPLETED
Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
12-23 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13. This study is being conducted in children who: * are be...
Eligibility Criteria
Inclusion
- Male or female toddlers ≥12 to \<24 months of age at the time of consent
- Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study
- 2 infant doses of Prevenar 13 prior to 12 months of age
Exclusion
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
- Major known congenital malformation or serious chronic disorder
- Other chronic medical or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Previous vaccination with any investigational pneumococcal vaccine, or planned receipt through study participation
Key Trial Info
Start Date :
June 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT05408429
Start Date
June 24 2022
End Date
June 1 2023
Last Update
September 19 2024
Active Locations (43)
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1
Gyerkőc- Med Szolgáltató és Kereskedelmi Betéti Társaság
Budapest, Hungary, 1042
2
Lurko-Med Kft Hazi Gyermekorvosi Rendelo
Budapest, Hungary, 1048
3
Elitance Duo Kft.
Budapest, Hungary, 1188
4
Private practice - Dr. Várhelyiné Dr. Torday Judit
Debrecen, Hungary, 4025