A Phase 2 Safety and Immunogenicity Study of a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers

Phase 1

• Conditions: Pneumococcal Infections; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-505154-18-00
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-14
• Study Completion: 2024-05-27
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Toddlers =11 and =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.

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the safety profile of the mPnC candidate administered as a 2-dose series in children =11 to =15 months of age.;Secondary Objective: To describe the immune responses elicited by the mPnC candidate.;Primary end point(s): Prompted local reactions (redness, swelling, and pain at the injection site), Prompted systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), Adverse events (AEs), Serious adverse events (SAEs)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Immunoglobulin G (IgG) concentrations for the candidate serotype;Secondary end point(s):Opsonophagocytic activity (OPA) titers for the candidate serotype