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HZ/su VACCINE

Phase 3

Respiratory Syncytial Virus (RSV) | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Nov 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment526
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06890416A Study to Evaluate the Safety and Immunogenicity of RSVpreF Coadministered With Herpes Zoster Vaccine in AdultsPHASE3 COMPLETED 526Apr 4, 2025Sep 30, 2025Nov 6, 202526 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) for RSV A and B in RSVpreF + herpes zoster subunit vaccine (HZ/su) Compared to RSVpreF Alone
1 month after vaccination with RSVpreF in the RSVpreF + HZ/su coadministration group to RSVpreF alone in the sequential administration group
Anti-gE antibody concentrations expressed as Geometric Mean Concentration (GMC) ratios in RSVpreF + HZ/su Compared to HZ/su Alone
1 month after the second dose of HZ/su in the RSVpreF + HZ/su coadministration group to HZ/su alone in the sequential administration group
Percentage of Participants reporting Local Reactions Within 7 Days after Vaccination
Within 7 Days after each vaccination (Vaccination on Day 1)

Describe local reactions (redness, swelling, and pain at the injection site) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary).

Percentage of Participants with Systemic Events Within 7 Days after Vaccination
Within 7 Days after each vaccination (Vaccination on Day 1)

Describe systemic events (fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary).

Percentage of Participants with Adverse Events (AEs)from Vaccination through 1 Month after Vaccination
Within 1 Month after last vaccination

Describe AEs occurring through 1 month after each study intervention administration

Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study
Within 4 Months after first study vaccination (Vaccination on Day 1)

Describe SAEs occurring through 4 months after the first study intervention administration.

Secondary Endpoints
NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
Before vaccination and 1 month after vaccination with RSVpreF
NTs for RSV A and RSV B expressed as seroresponse rate
1 month after vaccination with RSVpreF
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Coadministration GroupOTHER* Visit 1 (Day 1): RSVpreF + HZ/su dose 1 * Visit 3 (Month 2): HZ/su dose 2
Sequential Administration GroupOTHER* Visit 1 (Day 1): HZ/su dose 1 * Visit 2 (Month 1): RSVpreF * Visit 3 (Month 2): HZ/su dose 2
Interventions
NameTypeDescription
RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINEBIOLOGICALIntramuscular injection
HZ/su VACCINEBIOLOGICALintramuscular injection
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites26

Inclusion Criteria • Male and female participants 50 years of age and older who are healthy or with stable chronic medical conditions Exclusion Criteria * Current clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of HZ and/or history of clinically suspected or PCR-...

Countries:United StatesPuerto Rico
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