NCT06116591

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

A Phase 2, Randomized, Open-Label Trial to Describe the Safety and Immunogenicity of a Monovalent Pneumococcal Conjugate Candidate Administered As a 2-Dose Series in Healthy Toddlers 11 Through 15 Months of Age Who Previously Received the PCV10 Primary Series

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 11 Months – 15 Months
• Healthy volunteers: Accepted

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 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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
BIOLOGICAL	mPnC candidate	monovalent pneumococcal conjugate candidate
BIOLOGICAL	mPnC control	monovalent pneumococcal conjugate control

Timeline

• Start date: 2023-11-08
• Primary completion: 2024-05-27
• Completion: 2024-05-27
• First posted: 2023-11-03
• Last updated: 2025-05-08
• Results posted: 2025-05-08

Locations

11 sites across 2 countries: Finland, Poland