Recent Updates
Recently added Catalysts

Bivalent BNT162b2

Phase 2

Healthy Participants | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Dec 18, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment1,142
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05886777A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV).PHASE2 COMPLETED 1,142Jun 5, 2023Jan 1, 2024Dec 18, 202437 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Day 1 to Day 7 after Vaccination on Day 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 and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm) and graded as mild: 2.5 cm to 5.0 cm; moderate: greater than (\>) 5.0 cm to 10.0 cm; severe: \> 10 cm.

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

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

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.

Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Within 6 Months after Vaccination

An AE 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 was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event were included in this outcome measure.

Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) at 1 Month After Vaccination: Group 1 Versus Group 4
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section.

GMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 4
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section.

GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 1 Versus Group 3
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section.

GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 3
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section.

GMT and GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 hemagglutination inhibition titers (H1N1 A/Victoria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H1N1 A/Victoria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 hemagglutination inhibition titers (H3N2 A/Darwin) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H3N2 A/Darwin), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 hemagglutination inhibition titers (B/Austria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Austria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 hemagglutination inhibition titers (B/Phuket) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Phuket), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section.

GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section.

GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 2 Versus Group 3
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section.

GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 3
1 Month after Vaccination

GMTs and the corresponding 2-sided 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 SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section.

Secondary Endpoints
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4
1 Month after Vaccination
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 4
1 Month after Vaccination
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 7 Versus Group 3
1 Month after Vaccination
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALCombination \[RSVpreF+BNT162b2\] + Quadrivalent influenza vaccine (QIV)
Group 2EXPERIMENTALCombination \[RSVpreF+BNT162b2\] + placebo
Group 3ACTIVE_COMPARATORBNT162b2 + placebo
Group 4ACTIVE_COMPARATORRSVpreF + placebo
Group 5ACTIVE_COMPARATORQIV + placebo
Group 6EXPERIMENTALCoadministration RSVpreF + bivalent BNT162b2 + placebo
Group 7EXPERIMENTALCoadministration RSVpreF + bivalent BNT162b2 + QIV
Interventions
NameTypeDescription
Combination [RSVpreF+BNTb162b2]BIOLOGICALCombination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection
Bivalent BNT162b2 (original/Omi BA.4/BA.5)BIOLOGICALBivalent BNT162b2 given as an intramuscular injection
RSVpreFBIOLOGICALRSVpreF given as an intramuscular injection
QIVBIOLOGICALLicensed QIV given as an intramuscular injection
Normal Saline PlaceboBIOLOGICALNormal saline (0.9% sodium chloride solution for injection)
Unlock Study Design Details
Eligibility Criteria
Age Range65 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites37

Substudy A Inclusion Criteria: 1. Male or female participants ≥65 years of age at Visit 1 (Day 1). 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 ...

Countries:United States
Unlock Eligibility Criteria