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RSVpreF MDV

Phase 3

Respiratory Syncytial Virus (RSV) | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Sep 25, 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
RandomizedCONTROLLED
Total Trials1
Total Enrollment453
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06473519A Study to Assess Safety, Tolerability and Immunogenicity of RSVpreF From Multidose Vials in Healthy Female Adults.PHASE3 COMPLETED 453Jun 24, 2024Sep 20, 2024Sep 25, 20256 United States
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Study Endpoints
Primary Endpoints
Geometric Mean Titer (GMT) of Serum Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Before Vaccination
Before vaccination on Day 1

GMTs and corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).

GMT and Geometric Mean Ratio (GMR) of Serum NTs for RSV A and RSV B at 1 Month After Vaccination
1 month after Vaccination on Day 1

GMTs and corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A and B were reported in the descriptive data section of this outcome measure. GMR each for RSV A and RSV B was calculated as ratio of NTs of RSVpreF (MDV) to RSVpreF (SDV) and was reported in the statistical analysis section of this outcome measure.

Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Day 1 through Day 7 after Vaccination

Local reactions included redness, swelling and pain at injection site, reported in the electronic diary (e-diary) and the participant-reported reactogenicity (PARREACT) case report form (CRF). Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 centimeter (cm) and graded as mild: \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, severe: \>10.0 cm, Grade 4: necrosis (redness and swelling) or exfoliative dermatitis (redness). Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity, severe: prevented daily activity, Grade 4: emergency room visit or hospitalization for severe pain at injection site.

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, nausea, diarrhea, muscle pain and joint pain, recorded in the e-diary and PARREACT CRF. Fever measured in degree Celsius and ranged: mild (38.0 - 38.4); moderate (38.5 - 38.9); severe (39.0 - 40.0); Grade 4: \>40.0. Fatigue, headache, nausea, muscle and joint pain graded as: mild (didn't interfere with activity); moderate (some interference with activity); severe (prevented daily routine activity); Grade 4 \[emergency room (ER) visit or hospitalization). Vomiting graded as: mild (1-2 times in 24 hours\[h\]); moderate (\>2 times in 24h); severe (required intravenous hydration); Grade 4 (ER visit or hospitalization). Diarrhea graded as: mild (2-3 loose stools in 24h); moderate (4-5 loose stools in 24h); severe (6 or more loose stools in 24h); Grade 4 (ER visit or hospitalization).

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

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention were included in evaluation of this outcome measure. AEs included both serious AEs (SAEs) and all non-SAEs. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation.

Percentage of Participants With SAEs Throughout the Study
Within 42 to 49 days after Vaccination on Day 1 (maximum up to 1.6 months)

An AEs was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other important medical events per protocol of the study. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation.

Secondary Endpoints
Percentage of Participants Achieving Seroresponse for RSV A and RSV B of Serum NTs at 1 Month After Vaccination
1 Month after Vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
RSVpreF multidose vial (MDV)EXPERIMENTALRSVpreF with 2-PE formulated in an MDV
RSVpreF single-dose vial (SDV)EXPERIMENTALRSVpreF without 2-PE formulated in an SDV
Interventions
NameTypeDescription
RSVpreF MDVBIOLOGICALRSVpreF with 2-PE formulated in an MDV
RSVpreF SDVBIOLOGICALRSVpreF without 2-PE formulated in an SDV
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Eligibility Criteria
Age Range18 Years — 49 Years
SexFEMALE
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: 1. Healthy nonpregnant, nonbreastfeeding females 18 through 49 years of age at Visit 1 (Day 1). 2. Willing and able to comply with all scheduled visits, investigational plan, lifestyle considerations, and other study procedures. 3. Available for the duration of the study and can...

Countries:United States
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