Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mPnC candidate · 1 trial · 1 indication
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| mPnC candidate | BIOLOGICAL | monovalent pneumococcal conjugate candidate |
| mPnC control | BIOLOGICAL | monovalent pneumococcal conjugate control |
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 t...
The mPnC candidate is an investigational monovalent pneumococcal conjugate vaccine candidate being developed by Pfizer, Inc. It is a monoclonal antibody studied in healthy toddlers. It is not yet approved and remains in clinical development, with one completed Phase 2 trial conducted in Finland and Poland.
Pfizer, Inc. (ticker: PFE) is developing the mPnC candidate. The company ran a Phase 2 study of the monovalent pneumococcal conjugate candidate in healthy toddlers. Pfizer is the sole developer named for this asset.
The mPnC candidate is in Phase 2. One Phase 2 trial has been completed, and no active trials are currently listed. The candidate is investigational and has not been approved by the FDA.
The mPnC candidate has been studied in NCT06116591, a Phase 2 trial titled "A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers." The trial enrolled 105 participants, was randomized and active-controlled, and has been completed. It took place in Finland and Poland.
NCT06116591 enrolled 105 healthy toddlers aged 11 months and older, with both sexes eligible. The study was randomized and active-controlled, though it was not double-blind. It was conducted in Finland and Poland and has been completed.