NCT06077656

Dose-Ranging Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine

A Phase 2, Multicenter, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Inventprise Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Phase 2 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)

Detailed description

A Phase 2 multicenter, randomized, active-controlled, observer-blind study to evaluate safety, tolerability, and immunogenicity of three formulations of IVT PCV-25, a 25 valent conjugated pneumococcal vaccine with adjuvant. Adult participants will be randomized in a 4:3:2:2 ratio to receive 1 of 3 formulations or control.

Conditions

• Pneumococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	IVT PCV-25 Formulation A	25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and low dose adjuvant
BIOLOGICAL	IVT PCV-25 Formulation B	25 valent pneumococcal conjugate vaccine containing low dose polysaccharide and high dose adjuvant
BIOLOGICAL	IVT PCV-25 Formulation C	25 valent pneumococcal conjugate vaccine containing high dose polysaccharide and high dose adjuvant
BIOLOGICAL	PCV 20	20 valent pneumococcal conjugate vaccine

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-05-24
• Completion: 2024-05-24
• First posted: 2023-10-11
• Last updated: 2026-03-17
• Results posted: 2026-03-17

Locations

4 sites across 1 country: Canada