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

NCT06116591 | Completed Phase 2 Results

• 2 other identifiers: C48010022023-505154-18-00
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 11

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.

Conditions

Healthy Participants

Keywords

Pneumococcal Disease

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants With Local Reactions Within 7 Days After Dose 1

  Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: \> 0 to 2.0 centimeter (cm), moderate: \>2.0 to 7.0 cm, severe: \>7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site.

  Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)

• Percentage of Participants With Local Reactions Within 7 Days After Dose 2

  Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: \> 0 to 2.0 cm, moderate: \>2.0 to 7.0 cm, severe: \>7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site.

  Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)

• Percentage of Participants With Systemic Events Within 7 Days After Dose 1

  Fever (oral temperature \>= 38 degree Celsius \[degC\]) was categorized as \>=38.0-38.4 degC, \>38.4-38.9 degC, \>38.9-40.0 degC and \>40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability.

  Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)

• Percentage of Participants With Systemic Events Within 7 Days After Dose 2

  Fever (oral temperature \>= 38 degC) was categorized as \>=38.0-38.4 degC, \>38.4-38.9 degC, \>38.9-40.0 degC and \>40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability.

  Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)

• Percentage of Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2

  An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.

  From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]

• Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Dose 2

  An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic; other situations as judged by investigator.

  From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]

Secondary Outcomes (10)

• Geometric Mean Concentration (GMCs) of Pneumococcal Immunoglobulin G (IgG) at 1 Month After Dose 1

  1 month after Dose 1

• GMCs of Pneumococcal IgG at 1 Month After Dose 2

  1 month after Dose 2

• Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 1

  1 month after Dose 1

• Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 2

  1 month after Dose 2

• Geometric Mean Fold Rise (GMFRs) of Pneumococcal IgG From Before Dose 1 to 1 Month After Dose 1

  From before Dose 1 to 1 month after Dose 1

Study Arms (2)

mPnC candidate

EXPERIMENTAL

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

mPnC control

ACTIVE COMPARATOR

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

Interventions

mPnC candidate BIOLOGICAL

monovalent pneumococcal conjugate candidate

mPnC candidate

mPnC control BIOLOGICAL

monovalent pneumococcal conjugate control

mPnC control

Eligibility Criteria

• Age: 11 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

FVR, Kokkolan rokotetutkimusklinikka

Kokkola, Keski-Pohjanmaa, 67100, Finland

Location

FVR, Oulun rokotetutkimusklinikka

Oulu, North Ostrobothnia, 90220, Finland

Location

FVR, Tampereen rokotetutkimusklinikka

Tampere, Pirkanmaa, 33100, Finland

Location

FVR, Seinäjoen rokotetutkimusklinikka

Seinäjoki, South Ostrobothnia, 60100, Finland

Location

FVR, Turun rokotetutkimusklinikka

Turku, Southwest Finland, 20520, Finland

Location

FVR, Espoon rokotetutkimusklinikka

Espoo, Uusimaa, 02230, Finland

Location

FVR, Etelä-Helsingin rokotetutkimusklinikka

Helsinki, Uusimaa, 00100, Finland

Location

MeVac - Meilahti Vaccine Research Center

Helsinki, Uusimaa, 00290, Finland

Location

FVR, Järvenpään rokotetutkimusklinikka

Jarvenpaa, Uusimaa, 04400, Finland

Location

Centrum Medyczne Pratia Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

NZOZ Praktyka Lekarza Rodzinnego "ESKULAP"

Lublin, Lublin Voivodeship, 20-044, Poland

Location

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: November 8, 2023
• Primary Completion: May 27, 2024
• Study Completion: May 27, 2024
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

PL (2); FI (9)