Clinical trial NCT06116591: A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Participants
Keywords: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-11-03
Enrollment: 105
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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.

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 1
timeFrame: Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 2
timeFrame: Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 1
timeFrame: Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 2
timeFrame: Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)
measure: Percentage of Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2
timeFrame: From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]
measure: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Dose 2
timeFrame: From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]
Secondary outcomes:
measure: Geometric Mean Concentration (GMCs) of Pneumococcal Immunoglobulin G (IgG) at 1 Month After Dose 1
timeFrame: 1 month after Dose 1
measure: GMCs of Pneumococcal IgG at 1 Month After Dose 2
timeFrame: 1 month after Dose 2
measure: Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 1
timeFrame: 1 month after Dose 1
measure: Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 2
timeFrame: 1 month after Dose 2
measure: Geometric Mean Fold Rise (GMFRs) of Pneumococcal IgG From Before Dose 1 to 1 Month After Dose 1
timeFrame: From before Dose 1 to 1 month after Dose 1
measure: GMFRs of Pneumococcal IgG From 1 Month After Dose 1 to 1 Month After Dose 2
timeFrame: From 1 month after Dose 1 to 1 month after Dose 2
measure: Geometric Mean Titer (GMTs) of Pneumococcal Opsonophagocytic Activity (OPA) at 1 Month After Dose 1
timeFrame: 1 month after Dose 1
measure: GMTs of Pneumococcal OPA at 1 Month After Dose 2
timeFrame: 1 month after Dose 2
measure: GMFRs of Pneumococcal OPA From Before Dose 1 to 1 Month After Dose 1
timeFrame: From before Dose 1 to 1 month after Dose 1
measure: GMFRs of Pneumococcal OPA From 1 Month After Dose 1 to 1 Month After Dose 2
timeFrame: From 1 month after Dose 1 to 1 month after Dose 2
Other outcomes:
Locations:
city: Kokkola
country: Finland
facility: FVR, Kokkolan rokotetutkimusklinikka
state: Mellersta Österbotten
city: Tampere
country: Finland
facility: FVR, Tampereen rokotetutkimusklinikka
state: Pirkanmaa
city: Oulu
country: Finland
facility: FVR, Oulun rokotetutkimusklinikka
state: Pohjois-pohjanmaa
city: Seinäjoki
country: Finland
facility: FVR, Seinäjoen rokotetutkimusklinikka
state: Södra Österbotten
city: Espoo
country: Finland
facility: FVR, Espoon rokotetutkimusklinikka
state: Uusimaa
city: Helsinki
country: Finland
facility: FVR, Etelä-Helsingin rokotetutkimusklinikka
state: Uusimaa
city: Helsinki
country: Finland
facility: MeVac - Meilahti Vaccine Research Center
state: Uusimaa
city: Järvenpää
country: Finland
facility: FVR, Järvenpään rokotetutkimusklinikka
state: Uusimaa
city: Turku
country: Finland
facility: FVR, Turun rokotetutkimusklinikka
state: Varsinais-suomi
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego "ESKULAP"
state: Lubelskie
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: