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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumococcal Disease, Invasive
• Intervention / Treatment: Biological: Formulation B; Biological: Formulation C; Biological: Formulation D; Biological: Prevnar20

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.

• Study Type: Interventional
• Enrollment (Actual): 421
• Phase: Phase 2

Contacts and Locations

Study Locations

• Philippines
  • Cavite
    • Bacoor, Cavite, Philippines
      • Health Index Multispecialty Clinic
    • Kawit, Cavite, Philippines
      • Grand Centennial Homes Clinic
  • National Capital Region
    • Pasay, National Capital Region, Philippines
      • University of the Philippines-National Health Institute_Doña Nena Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Participants who meet all the following criteria may be included in the study:

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

Exclusion Criteria: Participants who meet any of the following criteria will be excluded from the study:

1. Congenital abnormality or serious chronic disorder requiring treatment or likely to affect normal growth or development
2. Any condition that may increase risk of study participation or interfere with interpretation of study results
3. 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)
4. History of sepsis or pneumonia
5. History of anaphylaxis or angioedema
6. History of severe reaction to immunization
7. Known hypersensitivity to any of the ingredients in either IVT PCV-25 or Prevnar 20
8. Contraindication to any concomitant vaccine or to Prevnar 20, according to each vaccine's product information
9. Prior receipt of a licensed or investigational pneumococcal vaccine
10. Prior receipt of any diphtheria, tetanus, pertussis, Hib, or polio vaccine
11. Prior receipt of > 1 dose of HepB vaccine
12. Receipt of HepB vaccine at age ≥ 30 days
13. 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
14. 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
15. Receipt of blood transfusion or blood products before Day 1 or planned receipt through Day 85
16. Receipt of any other IP before Day 1
17. Planned elective hospitalization or surgical procedure through the end of the study
18. Family member of employee of Inventprise, vendors, or research sites associated with the study
19. Any medical, psychiatric, or social condition, or occupational or other responsibility of the parent/guardian that, in the judgment of the Investigator, would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or an ability to provide informed consent

Temporary Delay Criteria: administration of IVT PCV-25 / Prevnar20 will be delayed for any participant who meets any of the following criteria:

1. Receipt of any inactivated vaccine within 14 days or any live vaccine within 28 days
2. Febrile illness (eg, temperature ≥ 38.0°C) or other acute illness within 48 hours
3. Any other signs or symptoms or medication use that could inhibit the proper vaccine administration of the IP or interpretation of diary data

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Low dose); 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; IVT PCV-25
Experimental: Group B (High dose); 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; IVT PCV-25
Experimental: Group C (Hybrid dose); 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; IVT PCV-25
Active Comparator: Group D (Comparator); Infant participants will receive three 0.5mL dose of Prevnar20 administered by intramuscular injection on Day 1, 29 and 57	Biological: Prevnar20; 20 valent pneumococcal conjugate vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	28 days after each dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMCs of concomitant vaccine antibodies at 28 days after Dose 3	To assess the humoral immunogenicity of vaccines administered concomitantly with IVT PCV-25	28 days after Dose 3
Percentage of participants achieving an antibody concentration threshold	To assess the humoral immunogenicity of vaccines administered concomitantly with IVT PCV-25	28 days after Dose 3
Number of days on systemic antibiotic treatment/days on study	To evaluate antibiotic use after administration of IVT PCV-25 administered at 6, 10, and 14 weeks of age	Day 1 to 6 months after Dose 3
Proportion of participants receiving systemic antibiotic treatment from Day 1 to 6 months after Dose 3	To evaluate antibiotic use after administration of IVT PCV-25 administered at 6, 10, and 14 weeks of age	Day 1 to 6 months after Dose 3 administered
Incidence of S pneumoniae serotype determination by polymerase chain reaction (PCR) assay in isolates collected from any participant with a pneumococcal infection during the study	To determine serotypes of any breakthrough S pneumoniae	Dose 1 to 6 months after Dose 3

Collaborators and Investigators

• Sponsor: Inventprise Inc.
• Collaborators: University of the Philippines-National Health Institute_Doña Nena Health Center; Health Index Multispecialty Clinic; Grand Centennial Homes Clinic
• Investigators: Study Director: Medical Director, Inventprise Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Actual): April 3, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 24, 2025

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Vaccine; Healthy Volunteer
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Pneumococcal Infections; Immunologic Factors; Physiological Effects of Drugs; D-Worm
• Other Study ID Numbers: IVT 121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No