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A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers
A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers

NCT06116591

CompletedPhase 2

Sponsor: Pfizer

Conditions: Healthy Participants

Interventions: mPnC candidate, mPnC control

Countries: Finland, Poland

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 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.

Eligibility overview

Sex: ALL

Age: 11 Months to 15 Months

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* 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 Criteria:

* 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.
Locations (11)
  • Kokkola, Keski-Pohjanmaa, Finland
  • Oulu, North Ostrobothnia, Finland
  • Tampere, Pirkanmaa, Finland
  • Seinäjoki, South Ostrobothnia, Finland
  • Turku, Southwest Finland, Finland
  • Espoo, Uusimaa, Finland
  • Helsinki, Uusimaa, Finland
  • Helsinki, Uusimaa, Finland
  • Jarvenpaa, Uusimaa, Finland
  • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • Lublin, Lublin Voivodeship, Poland