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RSVpreF+qIRV

Phase 1

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Nov 22, 2024

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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment508
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05788237A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older AdultsPHASE1 COMPLETED 508Mar 9, 2023Sep 27, 2023Nov 22, 20241 Argentina
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Study Endpoints
Primary Endpoints
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
SSA: From Day 1 to Day 7 after Vaccination 1

Local reactions included pain, redness and swelling at the injection site, recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: greater than (\>) 5.0 cm to 10.0 cm; severe: \> 10 cm.

SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month After Vaccination 1)

Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: \> 5.0 cm to 10.0 cm; severe: \> 10 cm.

SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
SSB: From Day 1 to Day 7 after Vaccination

Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: \> 5.0 cm to 10.0 cm; severe: \> 10 cm.

SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
SSA: From Day 1 to Day 7 after Vaccination 1

Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 degrees Celsius (deg C) and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.

SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month after Vaccination 1)

Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 deg C and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: \>2 times in 24h; severe: required IV hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.

SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
SSB: From Day 1 to Day 7 After Vaccination

Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature \>=38.0 deg C and categorized as mild: \>=38.0 to 38.4 deg C, moderate: \>38.4 to 38.9 deg C, severe: \>38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: \>2 times in 24h; severe: required IV hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.

SSA: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1
SSA: Within 1 Month after Vaccination 1

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. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.

SSA: Percentage of Participants Reporting AEs Within 1 Month After Vaccination 2
SSA: Within 1 Month after Vaccination 2

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. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.

SSB: Percentage of Participants Reporting AEs Throughout the Sub Study
SSB: From Day 1 of Vaccination up to 35 days of follow-up post 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. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.

SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) Throughout the Sub Study
SSA: From Day 1 (Vaccination 1) up to 35 days of follow-up post Vaccination 2 (Maximum up to 70 days)

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 was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.

SSB: Percentage of Participants Reporting SAEs Throughout the Sub Study
SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination (Maximum up to 36 days)

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 was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.

SSA: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NT) for Each RSV Subgroup (A or B) 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and RSVpreF Alone (Group 2)
SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1)

GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of RSV subgroup A (RSV A) or RSV subgroup B (RSV B) neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group.

SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2)
SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1)

GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of each strain neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group. The analysis was performed on the influenza strains: H1N1 A/Sydney, H3N2 A/Darwin, B/Austria, and B/Phuket.

Secondary Endpoints
SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination
SSB: At 1 Month after Vaccination (Day 1)
SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination
SSB: At 1 Month after Vaccination (Day 1)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
SSA Group 1: CombinationEXPERIMENTALCombination (RSVpreF + qIRV) (Visit 1) followed by placebo (Visit 2). RSVpreF and qIRV are administered as concomitantly but as individual injections.
SSA Group 2: SequentialEXPERIMENTALSequential administration of qIRV (Visit 1) followed by RSVpreF (Visit 2)
SSB Group 1: Combination (RSVpreF + qIRV) 1.0-mL formulationEXPERIMENTALRSVpreF lyophilized cake reconstituted with water for injection and mixed with qIRV, yielding an injection volume of 1.0 mL
SSB Group 2: Combination (RSVpreF +qIRV) 0.5-mL formulationEXPERIMENTALRSVpreF lyophilized cake reconstituted with qIRV to yield an injection volume of 0.5 mL
Interventions
NameTypeDescription
RSVpreF+qIRVBIOLOGICALRSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B combined with Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)
qIRVBIOLOGICALQuadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)
RSVpreFBIOLOGICALRSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B
PlaceboDRUG0.9% saline for injection
RSVpreF + qIRV 1.0 mL formulationBIOLOGICALRSVpreF containing 2 Stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B plus qIRV Encoding HA of 4 strains as recommended for the influenza season (2 A strains and 2 B strains) plus sterile water as diluent for injection
RSVpreF + qIRV 0.5 mL formulationBIOLOGICALRSVpreF containing 2 Stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B plus qIRV Encoding HA of 4 strains as recommended for the influenza season (2 A strains and 2 B strains)
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Substudy A: Inclusion Criteria: 1. Participants ≥60 years of age at study enrollment. 2. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures. 3. Healthy participants who are determin...

Countries:Argentina
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