NCT06790290

Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants

Phase 2, Randomized, Double-blind, Active-controlled Study Evaluating the Safety and Immunogenicity of IVT PCV-25 in Healthy Infants Administered With the WHO Expanded Programme on Immunization 3+0 Vaccine Schedule

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: Inventprise Inc. · Industry
• Sex: All
• Age: 42 Days – 56 Days
• Healthy volunteers: Accepted

Summary

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

Detailed description

A Phase 2 multicenter, randomized, active-controlled, double-blind study to evaluate safety and immunogenicity of a 3-dose intramuscular (IM) regimen of three formulations of IVT PCV-25, a 25 valent conjugated pneumococcal vaccine with adjuvant. Infant participants will be randomized in a 1:1:1:1 ratio to receive 3 IM injections of one IVT PCV-25 formulation or the active comparator (Prevnar 20) at 4-week intervals (at approximately 6, 10 and 14 weeks of age) with routine infant vaccines administered on the same day as IVT PCV-25/Prevnar 20.

Conditions

• Pneumococcal Disease, Invasive

Interventions

Type	Name	Description
BIOLOGICAL	Formulation B	IVT PCV-25
BIOLOGICAL	Formulation C	IVT PCV-25
BIOLOGICAL	Formulation D	IVT PCV-25
BIOLOGICAL	Prevnar20	20 valent pneumococcal conjugate vaccine

Timeline

• Start date: 2025-01-27
• Primary completion: 2025-04-03
• Completion: 2026-12-01
• First posted: 2025-01-24
• Last updated: 2025-09-02

Locations

3 sites across 1 country: Philippines