Pneumococcal Disease, Invasive
Conditions
Keywords
Vaccine, Healthy Volunteer
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.
Interventions
BIOLOGICALPrevnar20
20 valent pneumococcal conjugate vaccine
BIOLOGICALFormulation B
IVT PCV-25
BIOLOGICALFormulation C
IVT PCV-25
BIOLOGICALFormulation D
IVT PCV-25
Sponsors
University of the Philippines-National Health Institute_Doña Nena Health Center
Health Index Multispecialty Clinic
Grand Centennial Homes Clinic
Inventprise Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Subjects are randomized in four groups, 1:1:1:1, each receiving 3 doses of one of three vaccine formulations or comparator.
Eligibility
Sex/Gender
ALL
Age
42 Days to 56 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants achieving serotype-specific immunoglobulin G (IgG) concentration of ≥ 0.35 µg/mL at 28 days after each dose | 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 |
| Percentage of participants with reactogenicity events for 7 days after Doses 1, 2, and 3 | 7 days after Doses 1,2,3 | 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 |
| Percentage of participants with newly diagnosed chronic medical conditions (NDCMCs) from Dose 1 to 6 months after Dose 3 | 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 |
| Percentage of participants with medically attended AEs (MAAEs) from Dose 1 to 6 months after Dose 3 | 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 |
| Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 3 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Percentage of participants achieving serotype-specific immunoglobulin G (IgG) concentration of ≥ 0.35 µg/mL at 28 days after each dose | 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 |
| 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 | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| GMCs of concomitant vaccine antibodies at 28 days after Dose 3 | 28 days after Dose 3 | To assess the humoral immunogenicity of vaccines administered concomitantly with IVT PCV-25 |
| 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 | Dose 1 to 6 months after Dose 3 | To determine serotypes of any breakthrough S pneumoniae |
| Proportion of participants receiving systemic antibiotic treatment from Day 1 to 6 months after Dose 3 | Day 1 to 6 months after Dose 3 administered | To evaluate antibiotic use after administration of IVT PCV-25 administered at 6, 10, and 14 weeks of age |
| Number of days on systemic antibiotic treatment/days on study | 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 |
| Percentage of participants achieving an antibody concentration threshold | 28 days after Dose 3 | To assess the humoral immunogenicity of vaccines administered concomitantly with IVT PCV-25 |
Countries
Philippines
Outcome results
None listed