A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2, Randomized, Open-Label Trial to Describe the Safety and Immunogenicity of a Monovalent Pneumococcal Conjugate Candidate Administered As a 2-Dose Series in Healthy Toddlers 11 Through 15 Months of Age Who Previously Received the PCV10 Primary Series

Conditions
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Healthy Participants

Intervention / Treatment
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* Biological: mPnC candidate
* Biological: mPnC control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mPnC candidate<br>Participants will receive the mPnC candidate at Visit 1 and Visit 3 (approximately 8 weeks apart). PCV10 will also be given at Visit 1. | Biological: mPnC candidate<br>* monovalent pneumococcal conjugate candidate<br>|
| Active Comparator: mPnC control<br>Participants will receive the mPnC control at Visit 1 and Visit 3 (approximately 8 weeks apart). PCV10 will also be given at Visit 1. | Biological: mPnC control<br>* monovalent pneumococcal conjugate control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 |  | Within 7 Days after Dose 1 | 
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1 |  | Within 7 Days after Dose1 | 
| Percentage of participants reporting Adverse Events (AEs) within 1 month after study intervention administration |  | 2 months | 
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2 |  | Within 7 Days after Dose 2 | 
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2 |  | Within 7 Days after Dose 2 | 
| Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to through 1 month after Dose 2 |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG concentrations Geometric Mean Concentrations (GMCs) for the candidate serotype 1MPD1 |  | 1 month after Dose 1 | 
| IgG concentrations for the candidate serotype 1MPD2 |  | 1 month after Dose 2 | 
| IgG concentrations % responders for the candidate serotype 1MPD1 |  | 1 month after Dose 1 | 
| Percentages of participants % responders with predefined IgG concentration 1MPD2 |  | 1 month after Dose 2 | 
| Pneumococcal IgG Geometric Mean Fold Rises (GMFRs) 1MPD1 |  | From before Dose 1 to 1 month after Dose 1 | 
| Pneumococcal IgG GMFRs 1MPD2 |  | From 1-month after Dose 1 to 1 month after Dose 2 | 
| Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1MPD1 |  | 1 month after Dose 1 | 
| Pneumococcal OPA GMTs 1MPD2 |  | 1 month after Dose 2 | 
| Pneumococcal OPA GMFRs 1MPD1 |  | From before Dose 1 to 1 month after Dose 1 | 
| Pneumococcal OPA GMFRs 1MPD2 |  | from 1 month after Dose 1 to 1 month after Dose 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal Disease