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RSVpreF 120 µg

Phase 1

RESPIRATORY SYNCYTIAL VIRUS (RSV) | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Mar 6, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment128
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05900154A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of AgePHASE1 COMPLETED 128Jun 22, 2023Feb 29, 2024Mar 6, 202517 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Day 1 through Day 7 after Vaccination

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).

Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Day 1 through Day 7 after Vaccination

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.

Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Within 1 month post Vaccination

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.

Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
Within 6 months post Vaccination

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.

Percentage of Participants Reporting Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study
Within 6 months post Vaccination

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.

Secondary Endpoints
Geometric Mean Titer of the Neutralizing Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
Before vaccination and 1 month after vaccination
Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination
From before vaccination to 1 month after vaccination
Median Frequencies of RSV F Antigen-Specific Cluster of Differentiation 4 (CD4+) Thymus-Derived Lymphocytes (T) Cells Expressing Interferon (IFN) Gamma and Interleukin-4 (IL-4) Before Vaccination and 1 Month After Vaccination
Before vaccination and 1 Month after vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
standard dose in 5 to <18 years olds, healthyEXPERIMENTALstandard dose (120 µg)
standard dose in 5 to < 18 years olds, with chronic high risk conditionsEXPERIMENTALstandard dose (120 µg)
standard dose in 2 to < 5 years oldsEXPERIMENTALstandard dose (120 µg)
low dose in 5 to <18 years olds, healthyEXPERIMENTALlow dose (60 µg)
low dose in 5 to <18 years olds, with chronic high risk conditionsEXPERIMENTALlow dose (60 µg)
low dose in 2 to < 5 years oldsEXPERIMENTALlow dose (60 µg)
Interventions
NameTypeDescription
RSVpreF 120 µgBIOLOGICALRSVpreF standard dose level
RSVpreF 60 µgBIOLOGICALRSVpreF low dose level
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Eligibility Criteria
Age Range2 Years — 17 Years
SexALL
Healthy VolunteersYes
Study Sites17

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...

Countries:United States
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