| Primary | Percentage of Seropositive Participants at 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. | Evaluable immunogenicity (EI) population: Participants who received all 3 doses of the investigational product, had blood drawn for assay testing within the specified time frame for baseline and 4 weeks after the third vaccination, had valid and determinate assay result (NT titer) at baseline and 4 weeks after the third vaccination visit, were NT seronegative at baseline, and had no major protocol violations. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 4 weeks after Dose 3 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00098.0(92.9 to 99.8)
- OG001100(94.5 to 100)
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| Primary | Percentage of Participants With Local Reactions (LR) 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. | Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 1 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | |
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| Primary | Percentage of Participants With Local Reactions 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. | Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 2 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 |
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| Primary | Percentage of Participants With Local Reactions 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. | Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 3 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Primary | Percentage of Participants With Systemic Events (SE) 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). | Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product. Here, 'Number Analyzed' signifies those participants who were evaluable for the specified rows. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 1 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Primary | Percentage of Participants With Systemic Events 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). | Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product. Here, 'Number Analyzed' signifies those participants who were evaluable for the specified rows. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 2 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Primary | Percentage of Participants With Systemic Events 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). | Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and 'Number Analyzed' signifies those participants who were evaluable for the specified rows. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after Dose 3 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Primary | Percentage of Participants With Adverse Events (AEs) 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. | Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 1 month after Dose 1 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Primary | Percentage of Participants With Adverse Events (AEs) 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. | Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 1 month after Dose 2 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Primary | Percentage of Participants With Adverse Events (AEs) 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. | Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 1 month after Dose 3 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Primary | Percentage of Participants With Adverse Events (AEs) 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. | Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 1 month after any Dose | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Primary | Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study | 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. | Safety analysis population included all enrolled participants who received at least 1 dose of the investigational product. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From Day 1 up to end of study (up to approximately 13 months) | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Secondary | Percentage of Seropositive Participants at 4 Weeks After Dose 2 | Seropositivity rate based on the immune response was determined by NT. Participants who achieved TBEV NT titers >=1: 10 were considered as seropositive. Exact 2-sided 95% CI based on the Clopper and Pearson method was presented. | Evaluable immunogenicity (EI) population for the second dose: Participants who received the first 2 doses of the investigational product, had blood drawn for assay testing within the specified time frame for baseline and 4 weeks after the second vaccination, had valid and determinate assay result (NT titer) at baseline and 4 weeks after the second vaccination visit, were NT seronegative at baseline, and had no major protocol violations. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 4 weeks after Dose 2 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Secondary | Geometric Mean Titers (GMTs) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 and Dose 3 | GMTs and associated 2-sided 95% CIs were calculated as the mean of the assay results on the natural logarithmic scale based on Student's t distribution and then exponentiating the results. The lower limit of quantitation (LLOQ) value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ. | EI population: Participants who received all 3 doses of the investigational product, had blood drawn for assay testing within specified time frame for baseline and 4 weeks after the third vaccination, had valid and determinate assay result (NT titer) at baseline and 4 weeks after the third vaccination visit, were NT seronegative at baseline, and had no major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | 4 weeks after Dose 2 and Dose 3 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Secondary | Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 2 as Compared to Baseline | GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ. | Evaluable immunogenicity population for the second dose: Participants who received the first 2 doses of the investigational product, had blood drawn for assay testing within the specified time frame for baseline and 4 weeks after the second vaccination, had valid and determinate assay result (NT titer) at baseline and 4 weeks after the second vaccination visit, were NT seronegative at baseline, and had no major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | From Baseline to 4 weeks after Dose 2 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Secondary | Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 3 as Compared to Baseline | GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ. | EI population: Participants who received all 3 doses of the investigational product, had blood drawn for assay testing within specified time frame for baseline and 4 weeks after the third vaccination, had valid and determinate assay result (NT titer) at baseline and 4 weeks after the third vaccination visit, were NT seronegative at baseline, and had no major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | From Baseline to 4 weeks after Dose 3 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Secondary | Geometric Mean Fold Rise (GMFR) of TBEV Neutralizing Antibody Titers at 4 Weeks After Dose 3 as Compared to 4 Weeks After Dose 2 | GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ. | EI population: Participants who received all 3 doses of the investigational product, had blood drawn for assay testing within specified time frame for baseline and 4 weeks after the third vaccination, had valid and determinate assay result (NT titer) at baseline and 4 weeks after the third vaccination visit, were NT seronegative at baseline, and had no major protocol violations. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | From 4 weeks after Dose 2 to 4 weeks after Dose 3 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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| Secondary | Percentage of Participants With Neutralizing Antibody Titers >= Lower Limit of Quantification (LLOQ) | The LLOQ value for NT was 5. Assay results below the LLOQ were set to 0.5 × LLOQ. Percentage of participants with NT>=LLOQ and exact 2-sided 95% CI based on the Clopper and Pearson method was presented. | EI population: Participants who received all 3 doses of the investigational product, had blood drawn for assay testing within specified time frame for baseline and 4 weeks after the third vaccination, had valid and determinate assay result (NT titer) at baseline and 4 weeks after the third vaccination visit, were NT seronegative at baseline, and had no major protocol violations. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Before Dose 1, 4 weeks after Dose 2, Before Dose 3 and 4 weeks after Dose 3 | | | | ID | Title | Description |
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| OG000 | Adults (>=16 Years Old) | Participants aged >=16 years old received three doses of 0.5 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. | | OG001 | Pediatric (1 to <16 Years Old) | Participants aged 1 to <16 years old received three doses of 0.25 mL TBE vaccine intramuscularly as Dose 1 on Day 1, Dose 2 between 21 to 35 days after Dose 1 and Dose 3 between 150-365 days after Dose 2. Participants were followed up for safety for 21-35 days after Dose 3. |
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