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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Healthy Participants

Treatments: Biological: mPnC candidate; Biological: mPnC control

Study type: Interventional

Funder types: Industry

Identifiers

NCT06116591

2023-505154-18-00 (Other Identifier)

C4801002

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 11 to 15 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

mPnC candidate

Experimental group

Description:

Participants will receive the mPnC candidate at Visit 1 and Visit 3 (approximately 8 weeks apart). PCV10 will also be given at Visit 1.

Treatment:

Biological: mPnC candidate

mPnC control

Active Comparator group

Description:

Participants will receive the mPnC control at Visit 1 and Visit 3 (approximately 8 weeks apart). PCV10 will also be given at Visit 1.

Treatment:

Biological: mPnC control