A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers
- Conditions
- Healthy Participants
- Interventions
- Biological: mPnC candidateBiological: mPnC control
- Registration Number
- NCT06116591
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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
- 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
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mPnC candidate mPnC candidate Participants will receive the mPnC candidate at Visit 1 and Visit 3 (approximately 8 weeks apart). PCV10 will also be given at Visit 1. mPnC control mPnC control Participants will receive the mPnC control at Visit 1 and Visit 3 (approximately 8 weeks apart). PCV10 will also be given at Visit 1.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Local Reactions Within 7 Days After Dose 1 Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study) 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.
Percentage of Participants With Local Reactions Within 7 Days After Dose 2 Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study) 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.
Percentage of Participants With Systemic Events Within 7 Days After Dose 1 Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study) 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.
Percentage of Participants With Systemic Events Within 7 Days After Dose 2 Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study) 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.
Percentage of Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months] 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.
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Dose 2 From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months] 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.
- Secondary Outcome Measures
Name Time Method GMFRs of Pneumococcal OPA From 1 Month After Dose 1 to 1 Month After Dose 2 From 1 month after Dose 1 to 1 month after Dose 2 GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
Geometric Mean Concentration (GMCs) of Pneumococcal Immunoglobulin G (IgG) at 1 Month After Dose 1 1 month after Dose 1 GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution).
GMCs of Pneumococcal IgG at 1 Month After Dose 2 1 month after Dose 2 GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution).
Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 1 1 month after Dose 1 Predefined IgG concentrations was \>= 0.35 micrograms per milliliter (mcg/mL).
Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 2 1 month after Dose 2 Predefined level of IgG concentrations was \>= 0.35 mcg/mL.
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 GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
GMFRs of Pneumococcal IgG From 1 Month After Dose 1 to 1 Month After Dose 2 From 1 month after Dose 1 to 1 month after Dose 2 GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
Geometric Mean Titer (GMTs) of Pneumococcal Opsonophagocytic Activity (OPA) at 1 Month After Dose 1 1 month after Dose 1 GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
GMTs of Pneumococcal OPA at 1 Month After Dose 2 1 month after Dose 2 GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution).
GMFRs of Pneumococcal OPA From Before Dose 1 to 1 Month After Dose 1 From before Dose 1 to 1 month after Dose 1 GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution).
Trial Locations
- Locations (11)
FVR, Kokkolan rokotetutkimusklinikka
🇫🇮Kokkola, Mellersta Österbotten, Finland
FVR, Tampereen rokotetutkimusklinikka
🇫🇮Tampere, Pirkanmaa, Finland
FVR, Oulun rokotetutkimusklinikka
🇫🇮Oulu, Pohjois-pohjanmaa, Finland
FVR, Seinäjoen rokotetutkimusklinikka
🇫🇮Seinäjoki, Södra Österbotten, 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, Turun rokotetutkimusklinikka
🇫🇮Turku, Varsinais-suomi, Finland
Centrum Medyczne Pratia Bydgoszcz
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
NZOZ Praktyka Lekarza Rodzinnego "ESKULAP"
🇵🇱Lublin, Lubelskie, Poland