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Multivalent

Phase 2

Pneumococcal Infections | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Mar 2, 2021

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_CONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment1,481
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03512288Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy InfantsPHASE2 COMPLETED 460Apr 16, 2018Feb 11, 2020Mar 2, 202139 United States
NCT03313050A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of AgePHASE2 COMPLETED 511Oct 12, 2017May 24, 2019Jun 4, 202018 United States
NCT03313037Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of AgePHASE2 COMPLETED 444Oct 10, 2017Dec 10, 2018Dec 26, 201914 United States
NCT02955160A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 YearsPHASE1 COMPLETED 66Nov 3, 2016Aug 1, 2017Sep 11, 20181 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Within 7 days after Vaccination 1

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (0.5 to 2.0 centimeter \[cm\]), moderate (greater than \[\>\] 2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Within 7 days after Vaccination 2

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Within 7 days after Vaccination 3

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Within 7 days after Vaccination 4

Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement).

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

Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than or equal to (\>=) 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).

Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Within 7 days after Vaccination 2

Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).

Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Within 7 days after Vaccination 3

Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).

Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Within 7 days after Vaccination 4

Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as \>= 38.0 degree Celsius (C) and categorized to \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted).

Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3
From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months)

An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship.

Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4
From Vaccination 4 to 1 month after Vaccination 4

An AE was any untoward medical occurrence in study participant who received study vaccine without regard to possibility of causal relationship.

Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4
From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months)

An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.

Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4
From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months)

An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.

Stage 1: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
within 14 days after vaccination

Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.

Stage 2: Percentage of Participants With Local Reactions Within 14 Days After Vaccination
within 14 days after vaccination

Local reactions included pain at injection site, swelling and redness recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: \>2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.

Stage 1: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
within 14 days after vaccination

Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: \>=38.0 degrees Celsius (C), \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.

Stage 2: Percentage of Participants With Systemic Events Within 14 Days After Vaccination
within 14 days after vaccination

Systemic events included fever, fatigue, headache, muscle pain and joint pain recorded by participants in an e-diary. Fever was categorized as: \>=38.0 degrees C, \>=38.0 to 38.4 degrees C, \>38.4 to 38.9 degrees C, \>38.9 to 40.0 degrees C and \>40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as any, mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity.

Stage 1: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
within 1 month after vaccination

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.

Stage 2: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
within 1 month after vaccination

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.

Stage 1: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
within 6 months after vaccination

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
within 6 months after vaccination

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Stage 1: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
within 6 months after vaccination

An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.

Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
within 6 months after vaccination

An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.

Stage 2: Percentage of Participants With Serious Adverse Events (SAEs) Within 12 Months After Vaccination
within 12 months after vaccination

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Stage 2: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination
within 12 months after vaccination

An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects.

Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1
within 10 days after Vaccination 1

Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\>) 2.0 to 5.0 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (\>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.

Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1
within 1 month after Vaccination 1 (up to 35 days)

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1
within 6 months after Vaccination 1 (up to 196 days)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.

Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1
within 12 months after Vaccination 1 (up to 378 days)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.

Percentage of subjects reproting prompted local reactions within 14 days after vaccination (redness, swelling. limitation of arm movement, and pain at injection site).
Day 15
Percentage of subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, chills, rash, decreased appetite, nausea/vomiting, new muscle pain, aggravated muscle pain, new joint pain, and aggravated joint pain).
Day 15
Percentage of subjects reporting adverse events (AEs) within 1 month after vaccination.
1 month after vaccination
Percentage of subjects with clinical laboratory abnormalities after vaccination.
Day 6
Percentage of subjects reporting serious adverse events (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
6 months after vaccination
Secondary Endpoints
Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3
1 month after Vaccination 3
Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3
1 month after Vaccination 3
Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4
1 Month after Vaccination 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
MultivalentEXPERIMENTALPneumococcal conjugate vaccines
ControlACTIVE_COMPARATOR13vPnC
Stage 1 multivalent (ages 50-64 years)EXPERIMENTALmultivalent
Stage 1 Tdap (ages 50-64 years)ACTIVE_COMPARATORTdap
Stage 2 multivalent (ages 65-85 years)EXPERIMENTALmultivalent
Stage 2 polysaccharide (ages 65-85 years)ACTIVE_COMPARATORpolysaccharide
TdapACTIVE_COMPARATORTetanus, diphtheria, and pertussis vaccine
Interventions
NameTypeDescription
MultivalentBIOLOGICALPneumococcal conjugate vaccine
13vPnCBIOLOGICALPneumococcal conjugate vaccine
TdapBIOLOGICALTetanus, diphtheria, acellular pertussis vaccine
polysaccharideBIOLOGICAL23-valent pneumococcal polysaccharide vaccine
Prevnar 13BIOLOGICALPneumococcal conjugate vaccine
PPSV23BIOLOGICALPneumococcal polysaccharide vaccine
SalineOTHERPlacebo
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Eligibility Criteria
Age Range42 Days — 98 Days
SexALL
Healthy VolunteersYes
Study Sites39

Inclusion Criteria: * Male or female infant born at \>36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1). * Healthy infant determined by medical history, physical examination, and clinical judgment to be eligible for the stu...

Countries:United States
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