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TBE vaccine

Phase 3

Tick-Borne Encephalitis | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Nov 22, 2023

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
CONTROLLED
Total Trials1
Total Enrollment165
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04648241Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE) Vaccine in Healthy Japanese Participants 1 Year of Age and OlderPHASE3 COMPLETED 165Jan 18, 2021Feb 21, 2022Nov 22, 20236 Japan
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Study Endpoints
Primary Endpoints
Percentage of Seropositive Participants at 4 Weeks After Dose 3
4 weeks after Dose 3

Seropositivity rate based on the immune response was determined by neutralization test (NT). Participants who achieved tick-borne encephalitis virus (TBEV) NT titers \>=1: 10 were considered as seropositive. Exact 2-sided 95% confidence interval (CI) based on the Clopper and Pearson method was presented.

Percentage of Participants With Local Reactions (LR) Within 7 Days After Dose 1
Within 7 days after Dose 1

LR:participant or legally acceptable representative/parent/legal guardian using an electronic diary (e-diary). LR included redness, swelling and pain at injection site. Redness and swelling were measured using measuring device units. 1 measuring device unit =0.5 centimeter(cm). Redness and swelling were graded as: for participants \>=12 years of age, mild(greater than\[\>\] 2.0 to 5.0 cm), moderate(\>5.0 to 10.0 cm) and severe (\>10.0 cm); for participants less than (\<)12 years of age, mild(\>0 to 2.0 cm), moderate(\>2.0 to7.0 cm) and severe(\>7.0 cm). Pain at the injection site was graded as: for participants \>2 years of age, mild(does not interfere with activity), moderate(interferes with activity) and severe(prevents daily activity); for participants less than or equal to (\<=)2 years of age, mild(hurts if gently touched) moderate(hurts if gently touched with crying) and severe(causes limitation of limb movement). Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.

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

Local reactions were collected by participant or legally acceptable representative/parent/legal guardian using an e-diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured using measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as: for participants \>=12 years of age, mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm); for participants \<12 years of age, mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at the injection site was graded as: for participants \>2 years of age, mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity); for participants \<=2 years of age, mild (hurts if gently touched) moderate (hurts if gently touched with crying) and severe (causes limitation of limb movement). Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.

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

Local reactions were collected by participant or legally acceptable representative/parent/legal guardian using an e-diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured using measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as: for participants \>=12 years of age, mild (\> 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm); for participants \<12 years of age, mild (\>0 to 2.0 cm), moderate (\>2.0 to 7.0 cm) and severe (\>7.0 cm). Pain at the injection site was graded as: for participants \>2 years of age, mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity); for participants \<=2 years of age, mild (hurts if gently touched) moderate (hurts if gently touched with crying) and severe (causes limitation of limb movement). Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.

Percentage of Participants With Systemic Events (SE) Within 7 Days After Dose 1
Within 7 days after Dose 1

SE:participants or legally acceptable representative/parent/legal guardian using e-diary \& included fever:temperature \>=37.5 degree Celsius(C)\&categorized as 37.5to38.4, 38.5 to 38.9,39.0 to 40.0,\>40.0 degree C.Fatigue, headache, muscle pain, joint pain: mild(didn't interfere with activity), moderate(some interference with activity), severe(prevented daily activity). Vomiting: mild(1-2 times in 24 hours\[hrs\]), moderate(\>2 times in 24hrs), severe(required intravenous hydration). Diarrhea: mild(2-3 loose stools in 24hrs), moderate(4-5 loose stools in 24hrs), severe(6 or more loose stools in 24hrs). Decreased appetite:mild(decreased interest in eating),moderate(decreased oral intake), severe(refusal to feed).Drowsiness: mild(Increased sleeping bouts),moderate(slightly subdued interfering with daily activity),severe(disabling not interested in usual daily activity).Irritability:mild(easily consolable), moderate(required increased attention),severe(inconsolable, crying can't be comforted).

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

SE:participants or a legally acceptable representative/parent/legal guardian using e-diary and included fever:temperature \>=37.5 degreeC \& categorized as 37.5 to 38.4,38.5 to 38.9,39.0 to 40.0,\>40.0 degreeC.Fatigue, headache, muscle pain, joint pain: mild(didn't interfere with activity),moderate(some interference with activity), severe(prevented daily activity). Vomiting: mild(1-2 times in 24 hours\[hrs\]), moderate(\>2 times in 24hrs),severe(required intravenous hydration).Diarrhea: mild(2-3 loose stools in 24hrs), moderate(4-5 loose stools in 24hrs), severe(6 or more loose stools in 24hrs). Decreased appetite: mild(decreased interest in eating), moderate(decreased oral intake), severe(refusal to feed). Drowsiness: mild(Increased sleeping bouts), moderate(slightly subdued interfering with daily activity), severe(disabling not interested in usual daily activity).Irritability: mild(easily consolable), moderate(required increased attention),severe(inconsolable, crying can't be comforted).

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

Systemic events collected by participant using e-diary and included fever defined as temperature \>=37.5 degree C and categorized as 37.5 to 38.4, 38.5 to 38.9, 39.0 to 40.0, \>40.0 degree C. Fatigue, headache, muscle pain, joint pain: mild(didn't interfere with activity), moderate(some interference with activity), severe(prevented daily activity). Vomiting: mild(1-2 times in 24 hours\[hrs\]), moderate(\>2 times in 24hrs), severe(required intravenous hydration). Diarrhea: mild(2-3 loose stools in 24hrs), moderate(4-5 loose stools in 24hrs), severe(6 or more loose stools in 24hrs). Decreased appetite: mild(decreased interest in eating), moderate(decreased oral intake), severe(refusal to feed). Drowsiness: mild(Increased sleeping bouts), moderate(slightly subdued interfering with daily activity), severe(disabling not interested in usual daily activity). Irritability: mild(easily consolable), moderate(required increased attention), severe(inconsolable, crying can't be comforted).

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

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.

Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 2
Within 1 month after Dose 2

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.

Percentage of Participants With Adverse Events (AEs) Within 1 Month After Dose 3
Within 1 month after Dose 3

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.

Percentage of Participants With Adverse Events (AEs) Within 1 Month After Any Dose
Within 1 month after any Dose

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented.

Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
From Day 1 up to end of study (up to approximately 13 months)

An SAE was defined as any untoward medical occurrence that, at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect or that is considered to be an important medical event. Percentage of participants with SAEs and the exact 2-sided 95% CI based on the Clopper and Pearson method was presented.

Secondary Endpoints
Percentage of Seropositive Participants at 4 Weeks After Dose 2
4 weeks after Dose 2
Geometric Mean Titers (GMTs) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 and Dose 3
4 weeks after Dose 2 and Dose 3
Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 as Compared to Baseline
From Baseline to 4 weeks after Dose 2
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
≥16 Years OldEXPERIMENTALTBE vaccine 0.5 mL (intramuscular injection).
1 to <16 Years OldEXPERIMENTALTBE vaccine 0.25mL (intramuscular injection).
Interventions
NameTypeDescription
TBE vaccine 0.5 mLBIOLOGICALTBE vaccine 0.5 mL (intramuscular injection).
TBE vaccine 0.25 mLBIOLOGICALTBE vaccine 0.25 mL (intramuscular injection).
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Eligibility Criteria
Age Range1 Year — N/A
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Japanese male or female participants ≥1 years old at Visit 1. * Participants and/or a legally acceptable representative/parent/legal guardian are willing and able to comply with all scheduled visits, vaccination plan, and other study procedures including completion of the e-di...

Countries:Japan
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