NCT05540028

Study to Evaluate a 25-Valent Pneumococcal Conjugate Vaccine

A Phase 1, Multicenter, Randomized, Active-Controlled, Observer-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Inventprise's 25-Valent Pneumococcal Conjugate Vaccine in Healthy PCV-Naïve Adults (18 Through 40 Years)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Inventprise Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A first-in-human, Phase 1 trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)

Detailed description

A first-in-human, multicenter, randomized, active-controlled, observer-blind Phase 1 study of IVT PCV-25 designed to evaluate the safety, tolerability, and immunogenicity of the vaccine. Adult subjects will be randomized 1:1 to receive either IVT PCV-25 or Prevnar 20™.

Conditions

• Pneumococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	IVT PCV-25	25 valent pneumococcal conjugate vaccine
BIOLOGICAL	PCV 20	20 valent pneumococcal conjugate vaccine

Timeline

• Start date: 2022-09-28
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2022-09-14
• Last updated: 2023-08-30

Locations

1 site across 1 country: Canada