Phase 2 trial to evaluate safety and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in Healthy Infants
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
421
Health Index Multispecialty Clinic
Bacoor, Cavite, Philippines
Grand Centennial Homes Clinic
Kawit, Cavite, Philippines
University of the Philippines-National Health Institute_Doña Nena Health Center
Pasay, National Capital Region, Philippines
Percentage of participants with reactogenicity events for 7 days after Doses 1, 2, and 3
To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, Percentage of Participants with Reactogenicity Events 7 days after Doses 1,2,3
Time frame: 7 days after Doses 1,2,3
Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 3
To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age
Time frame: From Dose 1 to 28 days after Dose 3
Percentage of participants with medically attended AEs (MAAEs) from Dose 1 to 6 months after Dose 3
To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10,and 14 weeks of age
Time frame: From Dose 1 to 6 months after Dose 3
Percentage of participants with newly diagnosed chronic medical conditions (NDCMCs) from Dose 1 to 6 months after Dose 3
To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age
Time frame: From Dose 1 to 6 months after Dose 3
Percentage of participants achieving serotype-specific immunoglobulin G (IgG) concentration of ≥ 0.35 µg/mL at 28 days after each dose
To assess the safety and tolerability of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age
Time frame: from Dose 1 to 6 months after Dose 3
Percentage of participants achieving serotype-specific immunoglobulin G (IgG) concentration of ≥ 0.35 µg/mL at 28 days after each dose
To assess the humoral immunogenicity of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age
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20 valent pneumococcal conjugate vaccine
Time frame: 28 days after each dose
Ratio of geometric mean concentrations (GMCs) of serotype-specific IgG, comparing each IVT PCV-25 formulation to Prevnar 20 at 28 days after each dose
To assess the humoral immunogenicity of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age
Time frame: 28 days after each dose
Ratio of geometric mean titers (GMTs) of serotype-specific functional antibody measured by opsonophagocytic assay (OPA), comparing each IVT PCV-25 formulation to Prevnar 20 at 28 days after Dose 3
To assess the humoral immunogenicity of 3 formulations of IVT PCV-25 administered at 6, 10, and 14 weeks of age
Time frame: 28 days after each dose