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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06116591
• Other study ID #: C4801002
• Secondary ID: 2023-505154-18-0
• Status: Completed
• Phase: Phase 2
• Start date: November 8, 2023
• Est. completion date: May 27, 2024

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 27, 2024
• Est. primary completion date: May 27, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Months to 15 Months

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Biological:
• mPnC candidate
monovalent pneumococcal conjugate candidate
• mPnC control
monovalent pneumococcal conjugate control

Locations

Country	Name	City	State
Finland	FVR, Espoon rokotetutkimusklinikka	Espoo	Uusimaa
Finland	FVR, Etelä-Helsingin rokotetutkimusklinikka	Helsinki	Uusimaa
Finland	MeVac - Meilahti Vaccine Research Center	Helsinki	Uusimaa
Finland	FVR, Järvenpään rokotetutkimusklinikka	Järvenpää	Uusimaa
Finland	FVR, Kokkolan rokotetutkimusklinikka	Kokkola	Mellersta Österbotten
Finland	FVR, Oulun rokotetutkimusklinikka	Oulu	Pohjois-pohjanmaa
Finland	FVR, Seinäjoen rokotetutkimusklinikka	Seinäjoki	Södra Österbotten
Finland	FVR, Tampereen rokotetutkimusklinikka	Tampere	Pirkanmaa
Finland	FVR, Turun rokotetutkimusklinikka	Turku	Varsinais-suomi
Poland	Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz	Kujawsko-pomorskie
Poland	NZOZ Przychodnia Vitamed	Bydgoszcz	Kujawsko-pomorskie
Poland	Nzoz Vitamed	Bydgoszcz	Kujawsko-pomorskie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "Salmed"	Leczna	Lubelskie
Poland	NZOZ Praktyka Lekarza Rodzinnego "ESKULAP"	Lublin	Lubelskie
Poland	Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice	Siemianowice Slaskie	Slaskie
Poland	MICS Centrum Medyczne Torun	Torun	Kujawsko-pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Finland,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Local Reactions Within 7 Days After Dose 1		Within 7 Days after Dose 1
Primary	Percentage of Participants With Systemic Events Within 7 Days After Dose 1		Within 7 Days after Dose1
Primary	Percentage of participants reporting Adverse Events (AEs) within 1 month after study intervention administration		2 months
Primary	Percentage of Participants With Local Reactions Within 7 Days After Dose 2		Within 7 Days after Dose 2
Primary	Percentage of Participants With Systemic Events Within 7 Days After Dose 2		Within 7 Days after Dose 2
Primary	Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to through 1 month after Dose 2		2 months
Secondary	IgG concentrations Geometric Mean Concentrations (GMCs) for the candidate serotype 1MPD1		1 month after Dose 1
Secondary	IgG concentrations for the candidate serotype 1MPD2		1 month after Dose 2
Secondary	IgG concentrations % responders for the candidate serotype 1MPD1		1 month after Dose 1
Secondary	Percentages of participants % responders with predefined IgG concentration 1MPD2		1 month after Dose 2
Secondary	Pneumococcal IgG Geometric Mean Fold Rises (GMFRs) 1MPD1		From before Dose 1 to 1 month after Dose 1
Secondary	Pneumococcal IgG GMFRs 1MPD2		From 1-month after Dose 1 to 1 month after Dose 2
Secondary	Pneumococcal opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1MPD1		1 month after Dose 1
Secondary	Pneumococcal OPA GMTs 1MPD2		1 month after Dose 2
Secondary	Pneumococcal OPA GMFRs 1MPD1		From before Dose 1 to 1 month after Dose 1
Secondary	Pneumococcal OPA GMFRs 1MPD2		from 1 month after Dose 1 to 1 month after Dose 2

External Links

•   To obtain contact information for a study center near you, click here.