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.

Inclusion criteria

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

• 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

Exclusion criteria

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

• 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
• Receipt of any other IP before Day 1
• Planned elective hospitalization or surgical procedure through the end of the study
• Family member of employee of Inventprise, vendors, or research sites associated with the study
• 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:

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