Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal… (NCT06790290) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants
Philippines421 participantsStarted 2025-01-27
Plain-language summary
Phase 2 trial to evaluate safety and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25) in Healthy Infants
Who can participate
Age range42 Days – 56 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✕. 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
✕
What they're measuring
1
Percentage of participants with reactogenicity events for 7 days after Doses 1, 2, and 3
Timeframe: 7 days after Doses 1,2,3
2
Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 3
Timeframe: From Dose 1 to 28 days after Dose 3
3
Percentage of participants with medically attended AEs (MAAEs) from Dose 1 to 6 months after Dose 3
Timeframe: From Dose 1 to 6 months after Dose 3
4
Percentage of participants with newly diagnosed chronic medical conditions (NDCMCs) from Dose 1 to 6 months after Dose 3
Timeframe: From Dose 1 to 6 months after Dose 3
5
Percentage of participants achieving serotype-specific immunoglobulin G (IgG) concentration of ≥ 0.35 µg/mL at 28 days after each dose