Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TBE vaccine · 1 trial · 1 indication
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| ≥16 Years Old | EXPERIMENTAL | TBE vaccine 0.5 mL (intramuscular injection). |
| 1 to <16 Years Old | EXPERIMENTAL | TBE vaccine 0.25ｍL (intramuscular injection). |
| Name | Type | Description |
|---|---|---|
| TBE vaccine 0.5 mL | BIOLOGICAL | TBE vaccine 0.5 mL (intramuscular injection). |
| TBE vaccine 0.25 mL | BIOLOGICAL | TBE vaccine 0.25 mL (intramuscular injection). |
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...
TBE vaccine is used for the prevention of Tick-Borne Encephalitis, a viral infection transmitted by tick bites. It is being developed for use in healthy individuals, including children as young as 1 year of age, to stimulate an immune response against the TBE virus.
TBE vaccine is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the vaccine's immunogenicity, safety, and tolerability.
TBE vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine remains under evaluation for its safety and immune response.
TBE vaccine has one completed Phase 3 clinical trial, identified as NCT04648241. This study evaluated the immunogenicity, safety, and tolerability of the vaccine in healthy Japanese participants aged 1 year and older. The trial enrolled 165 participants and was conducted in Japan.
TBE vaccine is classified as a monoclonal antibody modality, though it is intended to function as a vaccine to prevent Tick-Borne Encephalitis. It is designed to elicit an immune response rather than to directly neutralize the virus as a therapeutic antibody would.