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

NCT ID: NCT06790290

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 421 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2026-12-31

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Formulation B

Intervention Type: BIOLOGICAL

IVT PCV-25

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

Group Type: EXPERIMENTAL

Formulation C

Intervention Type: BIOLOGICAL

IVT PCV-25

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

Group Type: EXPERIMENTAL

Formulation D

Intervention Type: BIOLOGICAL

IVT PCV-25

Group D (Comparator)

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

Group Type: ACTIVE_COMPARATOR

Prevnar20

Intervention Type: BIOLOGICAL

20 valent pneumococcal conjugate vaccine

Interventions

Formulation B

IVT PCV-25

Intervention Type: BIOLOGICAL

Formulation C

IVT PCV-25

Intervention Type: BIOLOGICAL

Formulation D

IVT PCV-25

Intervention Type: BIOLOGICAL

Prevnar20

20 valent pneumococcal conjugate vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 42 Days
• Maximum Eligible Age: 56 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of the Philippines-National Health Institute_Doña Nena Health Center

UNKNOWN

Sponsor Role: collaborator

Health Index Multispecialty Clinic

UNKNOWN

Sponsor Role: collaborator

Grand Centennial Homes Clinic

UNKNOWN

Sponsor Role: collaborator

Inventprise Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Inventprise Inc.

Locations

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

Countries

Philippines

Other Identifiers

IVT 121

Identifier Type: -

Identifier Source: org_study_id