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

NCT06790290•Inventprise Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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
+13 more criteria

Locations (3)

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

Key Dates

Start Date

January 27, 2025

Primary Completion Date

April 3, 2025

Completion Date

December 1, 2026

Last Updated

September 2, 2025

Enrollment

421

ACTUAL participants

Conditions

Pneumococcal Disease, Invasive

Interventions

Formulation B

BIOLOGICAL

Formulation C

BIOLOGICAL

Formulation D

BIOLOGICAL

Prevnar20

BIOLOGICAL