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 a monovalent pneumococcal conjugate vaccine candidate being studied in healthy toddlers. It is currently in Phase 2 clinical development for use in healthy participants, specifically toddlers aged 11 months and older.
Pfizer, Inc. (NYSE: PFE) is developing the mPnC candidate. The company is conducting a Phase 2 clinical trial of this monovalent pneumococcal conjugate vaccine candidate in healthy toddlers.
The mPnC candidate is in Phase 2 clinical development. A Phase 2 study of the vaccine candidate in healthy toddlers has been completed, with 105 participants enrolled.
The mPnC candidate is being studied in clinical trial NCT06116591, titled "A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers." This Phase 2 trial enrolled 105 participants in Finland and Poland and has been completed.
No, the mPnC candidate is a vaccine, specifically a monovalent pneumococcal conjugate candidate. It is being developed for use in healthy toddlers and is currently in Phase 2 clinical development.