Phase 2
Completed N=105
A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers
Healthy Participants
Source: ClinicalTrials.gov NCT06116591 ↗
Enrolled (actual)
105
Serious AEs
1.9%
Results posted
May 2025
Primary outcomePrimary: Percentage of Participants With Local Reactions Within 7 Days After Dose 1 — 17.3; 15.1; 17.3; 9.4 Percentage of participants
Summary
The purpose of the study is to learn about the effects of a monovalent (single component) pneumococcal conjugate candidate (mPnC candidate) when given to toddlers between 11 and 15 months of age.
All participants in this study will receive 2 doses of either mPnC candidate or mPnC control at the clinic approximately 8 weeks apart. All participants will also receive their third (toddler) dose of PCV10 at Visit 1.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 1 |
17.3; 15.1; 17.3; 9.4; 0; 5.7 | — |
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Dose 2 |
13.5; 17.6; 9.6; 15.7; 3.8; 2.0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 1 |
7.7; 18.9; 3.8; 9.4; 1.9; 7.5 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Dose 2 |
13.5; 15.7; 9.6; 7.8; 1.9; 2.0 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 |
84.6; 75.5 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Dose 2 |
1.9; 1.9 | — |
| SECONDARY Geometric Mean Concentration (GMCs) of Pneumococcal Immunoglobulin G (IgG) at 1 Month After Dose 1 |
7.53; 5.73 | — |
| SECONDARY GMCs of Pneumococcal IgG at 1 Month After Dose 2 |
17.41; 8.08 | — |
| SECONDARY Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 1 |
98.0; 100.0 | — |
| SECONDARY Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 2 |
100.0; 100.0 | — |
| SECONDARY Geometric Mean Fold Rise (GMFRs) of Pneumococcal IgG From Before Dose 1 to 1 Month After Dose 1 |
496.7; 306.3 | — |
| SECONDARY GMFRs of Pneumococcal IgG From 1 Month After Dose 1 to 1 Month After Dose 2 |
2.4; 1.5 | — |
| SECONDARY Geometric Mean Titer (GMTs) of Pneumococcal Opsonophagocytic Activity (OPA) at 1 Month After Dose 1 |
425; 447 | — |
| SECONDARY GMTs of Pneumococcal OPA at 1 Month After Dose 2 |
645; 544 | — |
| SECONDARY GMFRs of Pneumococcal OPA From Before Dose 1 to 1 Month After Dose 1 |
40.7; 42.6 | — |
| SECONDARY GMFRs of Pneumococcal OPA From 1 Month After Dose 1 to 1 Month After Dose 2 |
1.5; 1.3 | — |
Eligibility Criteria
Key Inclusion Criteria
- Toddlers ≥11 to ≤15 months of age at the time of consent.
- Have received exactly 2 infant doses of PCV10 according to a local immunization schedule.
- Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Key Exclusion Criteria
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of study intervention, 13vPnC, 20vPnC, or any diphtheria toxoid-containing vaccine.
- significant neurological disorder or history of seizure (excluding febrile seizure) or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders.
- Major known congenital malformation or serious chronic disorder.
- History of microbiologically proven invasive disease caused by S pneumoniae.
- Previous vaccination with any licensed pneumococcal vaccine (other than the PCV10 primary infant series) or investigational pneumococcal vaccine, or planned receipt of nonstudy pneumococcal vaccine during study participation.
Data sourced from ClinicalTrials.gov (NCT06116591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.