SKYSAVI-5 Study

PCV21 is a new pneumococcal vaccine that aims to provide broader coverage against pneumococcal disease in children aged 2 months and older.

PCV21 has already been tested in several other studies. None of the conducted studies showed any safety concerns, and PCV21 was well-tolerated in both adults and children.

This trial is conducted in two patient-centered phases: vaccination and follow-up. Participation in the study involves 6 clinic visits and 5 phone calls from study staff. Patients can be in the trial for up to 19 months.

The purpose of this study is:

• To learn more about the vaccine called PCV21
• To compare the safety of PCV21 to Prevnar 20® (a pneumococcal vaccine already on the market)

Population of the study: Healthy infants age approximately 2 months (42 to 89 days)
Intervention: Phase 3, randomized, modified double-blind, of a 4-dose regimen of a 21-valent pneumococcal conjugate vaccine in healthy infants and toddlers
Control: Eligible participants will be randomized to receive a 4-dose regimen of either PCV21 or 20vPCV in a 3:1 ratio. Active-controlled, parallel-group, control = 20vPCV
Outcome: To investigate the safety of a 4-dose regimen of a 21-valent pneumococcal conjugate vaccine in healthy infants and toddlers

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Trial Information

Target Enrollment: Largest feasible sample size; multicenter competitive enrollment
Sponsor: Sanofi Pasteur (SNY)
Duration of Study: 19 months

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Study Principal Investigators

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Links

Parent Information Sheet

 

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