NCT05408429

Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13

A PHASE 3, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY TODDLERS 12 THROUGH 23 MONTHS OF AGE WITH 2 PRIOR INFANT DOSES OF PREVENAR 13

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

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 between 12 to 23 months of age; * are healthy as determined by the study doctors; * have received 2 doses of Prevnar 13 during the first year in life. Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.

Conditions

• Pneumococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	20-valent pneumococcal conjugate vaccine	20-valent pneumococcal conjugate vaccine
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	13-valent pneumococcal conjugate vaccine

Timeline

• Start date: 2022-06-24
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-06-07
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

43 sites across 3 countries: Hungary, Poland, Spain