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

NCT06790290 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: IVT 121
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Pneumococcal Disease, Invasive

Keywords

Vaccine; Healthy Volunteer

Outcome Measures

Primary Outcomes (5)

• 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

  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

  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

  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

  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

  from Dose 1 to 6 months after Dose 3

Secondary Outcomes (3)

• Percentage of participants achieving serotype-specific immunoglobulin G (IgG) concentration of ≥ 0.35 µg/mL at 28 days after each dose

  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

  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

  28 days after each dose

Other Outcomes (5)

• GMCs of concomitant vaccine antibodies at 28 days after Dose 3

  28 days after Dose 3

• Percentage of participants achieving an antibody concentration threshold

  28 days after Dose 3

• Number of days on systemic antibiotic treatment/days on study

  Day 1 to 6 months after Dose 3

Study Arms (4)

Group A (Low dose)

EXPERIMENTAL

Infant participants will receive three 0.5mL dose of IVT PCV-25 Formulation B administered by intramuscular injection on Day 1, 29 and 57

Biological: Formulation B

Group B (High dose)

EXPERIMENTAL

Infant participants will receive three 0.5mL dose of IVT PCV-25 Formulation C administered by intramuscular injection on Day 1, 29 and 57

Biological: Formulation C

Group C (Hybrid dose)

EXPERIMENTAL

Infant participants will receive three 0.5mL dose of IVT PCV-25 Formulation D administered by intramuscular injection on Day 1, 29 and 57

Biological: Formulation D

Group D (Comparator)

ACTIVE COMPARATOR

Infant participants will receive three 0.5mL dose of Prevnar20 administered by intramuscular injection on Day 1, 29 and 57

Biological: Prevnar20

Interventions

Formulation B BIOLOGICAL

IVT PCV-25

Group A (Low dose)

Formulation C BIOLOGICAL

IVT PCV-25

Group B (High dose)

Formulation D BIOLOGICAL

IVT PCV-25

Group C (Hybrid dose)

Prevnar20 BIOLOGICAL

20 valent pneumococcal conjugate vaccine

Group D (Comparator)

Eligibility Criteria

• Age: 42 Days - 56 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 42 to 56 days, inclusive, at the time of Dose 1
• Good general health status, as determined by medical history, physical examination, vital signs, and clinical judgment
• Product of normal full-term pregnancy (37 to 42 weeks' gestation)
• Birth weight ≥ 2000 g
• Length and weight ≥ -2 standard deviations (SD) for age and sex, according to the Philippine national child growth standards (see Appendix 1)
• Willingness of parent/guardian for the child to attend all protocol visits and to have all protocol-required procedures
• Provision of written informed consent by legally acceptable representative

You may not qualify if:

• Congenital abnormality or serious chronic disorder requiring treatment or likely to affect normal growth or development
• Any condition that may increase risk of study participation or interfere with interpretation of study results
• Immunodeficiency or chronic administration (\> 14 consecutive days) of immunosuppressant or other immune-modifying drugs (see details in Section 6.6.2), including systemic glucocorticoids, within 6 months before Day 1 (topical, intra- articular, or inhaled glucocorticoids permitted)
• History of sepsis or pneumonia
• History of anaphylaxis or angioedema
• History of severe reaction to immunization
• Known hypersensitivity to any of the ingredients in either IVT PCV-25 or Prevnar 20
• Contraindication to any concomitant vaccine or to Prevnar 20, according to each vaccine's product information
• Prior receipt of a licensed or investigational pneumococcal vaccine
• Prior receipt of any diphtheria, tetanus, pertussis, Hib, or polio vaccine
• Prior receipt of \> 1 dose of HepB vaccine
• Receipt of HepB vaccine at age ≥ 30 days
• Receipt of an inactivated vaccine within 14 days before Day 1 or planned receipt through Day 85 other than as described in Section 6.6.1 and Section 6.6.3
• Receipt of a live vaccine within 28 days before Day 1 or planned receipt through Day 85 other than as described in Section 6.6.1 and Section 6.6.3
• Receipt of blood transfusion or blood products before Day 1 or planned receipt through Day 85

Sponsors & Collaborators

• Inventprise Inc.: lead
• University of the Philippines-National Health Institute_Doña Nena Health Center: collaborator
• Health Index Multispecialty Clinic: collaborator
• Grand Centennial Homes Clinic: collaborator

Study Sites (3)

Health Index Multispecialty Clinic

Bacoor, Cavite, Philippines

Location

Grand Centennial Homes Clinic

Kawit, Cavite, Philippines

Location

University of the Philippines-National Health Institute_Doña Nena Health Center

Pasay, National Capital Region, Philippines

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

D-Worm

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Medical Director

  Inventprise Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects are randomized in four groups, 1:1:1:1, each receiving 3 doses of one of three vaccine formulations or comparator.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 24, 2025
• Study Start: January 27, 2025
• Primary Completion: April 3, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PH (3)