Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RSVpreF 120 µg · 1 trial · 1 indication
Local reactions were collected in the electronic diary (e-diary) from Day 1 through Day 7 after vaccination. Local reactions included pain at injection site, redness, and swelling. For participants greater than or equal to (\>=) 2 years to \<12 years of age, redness and swelling were graded as mild: 0.5 to 2.0 centimeter (cm), moderate: \>2.0 to 7.0 cm, and severe: \> 7 cm; for participants \>=12 years of age, mild: \> 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, and severe: \>10 cm. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Systemic events included fever, fatigue, headache, vomiting, diarrhea, muscle pain and joint pain and were recorded by participants using e-diary. Fever: oral temperature \>= 38.0 degree Celsius (deg C) and categorized as \>=38.0 to 38.4 deg C (mild), \>38.4 to 38.9 deg C (moderate), and \>38.9 to 40.0 deg C (severe). Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), and severe (prevented daily routine activity). Vomiting was graded mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, and severe: required intravenous hydration. Diarrhea was graded mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h.
AE was defined as any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. AEs included serious and all non-serious AE. SAEs were defined as AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was congenital anomaly or birth defect; was suspected transmission via Pfizer product of infectious agent, pathogenic or nonpathogenic or was considered to be an important medical event. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were included.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability or incapacity; was a congenital anomaly or birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event.
An NDCMC was defined as a disease or medical condition, which was not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
| Arm | Type | Description |
|---|---|---|
| standard dose in 5 to <18 years olds, healthy | EXPERIMENTAL | standard dose (120 µg) |
| standard dose in 5 to < 18 years olds, with chronic high risk conditions | EXPERIMENTAL | standard dose (120 µg) |
| standard dose in 2 to < 5 years olds | EXPERIMENTAL | standard dose (120 µg) |
| low dose in 5 to <18 years olds, healthy | EXPERIMENTAL | low dose (60 µg) |
| low dose in 5 to <18 years olds, with chronic high risk conditions | EXPERIMENTAL | low dose (60 µg) |
| low dose in 2 to < 5 years olds | EXPERIMENTAL | low dose (60 µg) |
| Name | Type | Description |
|---|---|---|
| RSVpreF 120 µg | BIOLOGICAL | RSVpreF standard dose level |
| RSVpreF 60 µg | BIOLOGICAL | RSVpreF low dose level |
Inclusion Criteria: 1. Participants 2 to \<18 years of age at enrollment 2. Participants 2 to \<18 years of age should either be healthy or be considered by the investigator to be at high risk of RSV disease based on the presence of 1 of the following chronic medical conditions: * Cystic fibros...
RSVpreF 120 µg is an investigational monoclonal antibody being studied for the prevention of respiratory syncytial virus (RSV) infection. It is intended for use in children aged 2 to less than 18 years. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
RSVpreF 120 µg is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and immune activity of this investigational monoclonal antibody for respiratory syncytial virus (RSV) prevention.
RSVpreF 120 µg is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the safety and immune activity of the drug in children aged 2 to less than 18 years. The drug remains investigational and has not received regulatory approval.
RSVpreF 120 µg has been studied in one completed Phase 1 clinical trial with the identifier NCT05900154. The trial, titled 'A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age,' enrolled 128 participants in the United States and evaluated the drug's safety and immune response.
RSVpreF 120 µg is a specific dosage form of the investigational monoclonal antibody RSVpreF. The 120 µg designation refers to the dose being studied. The drug is being evaluated for the prevention of respiratory syncytial virus (RSV) infection in children aged 2 to less than 18 years.