Encephalitis, Tick-Borne
Conditions
Brief summary
The main purpose of this study is to assess the seropersistence of TBE virus antibodies in children, adolescents and young adults who received the first booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.
Interventions
BIOLOGICALFSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)
Dosage form: solution/suspension; injectable. Dosage frequency: once. Mode of administration: intramuscular.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Subjects who participated in precursor Study 700401 and meet ALL of the following criteria are eligible for participation in this study: * Subject / parent(s) / legal guardian(s) provide(s) written informed consent (according to national law); * Subject provides written assent to the study according to age and capacity of understanding; * Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml during the course of precursor Study 700401; * Blood was drawn after the first booster vaccination in precursor Study 700401; * Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the Subject Diary).
Exclusion criteria
Subjects who participated in precursor Study 700401 and meet ANY of the following criteria are not eligible for participation in this study: * Subject received any TBE vaccination since his / her first booster vaccination in precursor Study 700401; * Subject has a history of infection with or vaccination against other flaviviruses (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first booster vaccination in precursor Study 700401; * Subject is known to be HIV positive since his / her first booster vaccination in precursor Study 700401 (a special HIV test is not required for the purpose of the study); * Subject received a blood product or immunoglobulins within 90 days before any blood draw or in the period between the blood draw and the booster vaccination (as applicable); * Subject has a known or suspected problem with drug or alcohol abuse (\> 4 liters of wine/week or equivalent level of other alcoholic beverages); * Subject / parent(s) / legal guardian(s) is / are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner / spouse, siblings) as well as employees of the investigator or the site conducting the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | 21-35 days after second TBE booster vaccination | Seropositivity rate was reported as percentage of participants with NT level \>=10 at 21-35 days after the second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. |
| Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 21-35 days after first TBE booster vaccination | Seropositivity rate was reported as percentage of participants with NT level greater than equal to (\>=) 10 at 21-35 days after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants. |
| Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 38 months after first TBE booster vaccination | Seropositivity rate was reported as percentage of participants with NT level \>=10 at 38 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants. |
| Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 46 months after first TBE booster vaccination | Seropositivity rate was reported as percentage of participants with NT level \>=10 at 46 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. |
| Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 58 months after first TBE booster vaccination | Seropositivity rate was reported as percentage of participants with NT level \>=10 at 58 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. |
| Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 70 months after first TBE booster vaccination | Seropositivity rate was reported as percentage of participants with NT level \>=10 at 70 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. |
| Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 82 months after first TBE booster vaccination | Seropositivity rate was reported as percentage of participants with NT level \>=10 at 82 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. |
| Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 94 months after first TBE booster vaccination | Seropositivity rate was reported as percentage of participants with NT level \>=10 at 94 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. |
| Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 106 months after first TBE booster vaccination | Seropositivity rate was reported as percentage of participants with NT level \>=10 at 106 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. |
| Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 118 months after first TBE booster vaccination | Seropositivity rate was reported as percentage of participants with NT level \>=10 at 118 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | 21-35 days after second TBE booster vaccination | Seropositivity rate was reported as percentage of participants with ELISA level \>126 VIE U/mL at 21-35 days after second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. |
| Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination | Antibody against TBE booster vaccination was measured as geometric mean concentration (GMC) by ELISA level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations. |
| Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | 21-35 days after second TBE booster vaccination | Antibody against TBE booster vaccination was measured as GMC by ELISA level after the second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations. |
| Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination | Antibody against TBE booster vaccination was measured as geometric mean titer (GMT) by NT level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers. |
| Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | 21-35 days after second TBE booster vaccination | Antibody against TBE booster vaccination was measured as GMT by NT level after second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers. |
| Geometric Mean Fold Rise (GMFR) in Antibody Concentrations After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination | GMFR in antibody concentration from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises. |
| Geometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT) | Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination | GMFR in antibody titers from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises. |
| Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | From second booster vaccination up to 21-35 days after the vaccination | Injection site reactions included swelling, induration, redness, injection site pain, tenderness, ecchymosis and hematoma. Systemic reaction included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, malaise and fatigue. Participants with any injection site reaction and systemic reaction after second TBE booster vaccination in Study 700802 were reported in this outcome measure. |
| Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination | Seropositivity rate was reported as percentage of participants with ELISA level greater than (\>) 126 vienna units per milliliter (VIE U/mL) at each blood sampling time point after first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. |
Countries
Austria, Germany, Poland
Participant flow
Pre-assignment details
This study is a follow-up study of 700401 (NCT00161967) in which participants received the first booster vaccination.
Participants by arm
| Arm | Count |
|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. | 179 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 5 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 50 |
Baseline characteristics
| Characteristic | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | — |
|---|---|---|
| Age, Continuous | 15.1 Years STANDARD_DEVIATION 4.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 88 Participants | — |
| Sex: Female, Male Male | 91 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 1 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Seropositivity rate was reported as percentage of participants with NT level \>=10 at 106 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.
Time frame: 106 months after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 94.9 Percentage of participants |
Primary
Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Seropositivity rate was reported as percentage of participants with NT level \>=10 at 118 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.
Time frame: 118 months after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 90.3 Percentage of participants |
Primary
Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Seropositivity rate was reported as percentage of participants with NT level greater than equal to (\>=) 10 at 21-35 days after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants.
Time frame: 21-35 days after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 100.0 Percentage of participants |
Primary
Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
Seropositivity rate was reported as percentage of participants with NT level \>=10 at 21-35 days after the second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.
Time frame: 21-35 days after second TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | 100.0 Percentage of participants |
Primary
Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Seropositivity rate was reported as percentage of participants with NT level \>=10 at 38 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants.
Time frame: 38 months after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 100.0 Percentage of participants |
Primary
Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Seropositivity rate was reported as percentage of participants with NT level \>=10 at 46 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.
Time frame: 46 months after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 100.0 Percentage of participants |
Primary
Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Seropositivity rate was reported as percentage of participants with NT level \>=10 at 58 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.
Time frame: 58 months after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 99.4 Percentage of participants |
Primary
Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Seropositivity rate was reported as percentage of participants with NT level \>=10 at 70 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.
Time frame: 70 months after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 98.1 Percentage of participants |
Primary
Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Seropositivity rate was reported as percentage of participants with NT level \>=10 at 82 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.
Time frame: 82 months after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 96.8 Percentage of participants |
Primary
Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Seropositivity rate was reported as percentage of participants with NT level \>=10 at 94 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.
Time frame: 94 months after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | 95.5 Percentage of participants |
Secondary
Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
Antibody against TBE booster vaccination was measured as GMC by ELISA level after the second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: 21-35 days after second TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | 1844.1 VIE U/mL |
Secondary
Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Antibody against TBE booster vaccination was measured as geometric mean concentration (GMC) by ELISA level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations.
Time frame: 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 21-35 days | 4368.2 VIE U/mL |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 38 months | 1081.5 VIE U/mL |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 46 months | 1212.1 VIE U/mL |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 58 months | 1005.1 VIE U/mL |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 70 months | 883.4 VIE U/mL |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 82 months | 728.6 VIE U/mL |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 94 months | 636.8 VIE U/mL |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 106 months | 561.0 VIE U/mL |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 118 months | 506.4 VIE U/mL |
Secondary
Geometric Mean Fold Rise (GMFR) in Antibody Concentrations After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
GMFR in antibody concentration from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises.
Time frame: Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Fold Rise (GMFR) in Antibody Concentrations After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | 8.6 Fold rise |
Secondary
Geometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT)
GMFR in antibody titers from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises.
Time frame: Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT) | 5.2 Fold rise |
Secondary
Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
Antibody against TBE booster vaccination was measured as GMT by NT level after second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers.
Time frame: 21-35 days after second TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | 126.8 Titers |
Secondary
Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Antibody against TBE booster vaccination was measured as geometric mean titer (GMT) by NT level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers.
Time frame: 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 21-35 days | 380.7 Titers |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 38 months | 162.1 Titers |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 46 months | 108.1 Titers |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 58 months | 111.3 Titers |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 70 months | 123.4 Titers |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 82 months | 122.3 Titers |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 94 months | 82.8 Titers |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 106 months | 56.0 Titers |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 118 months | 53.9 Titers |
Secondary
Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
Injection site reactions included swelling, induration, redness, injection site pain, tenderness, ecchymosis and hematoma. Systemic reaction included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, malaise and fatigue. Participants with any injection site reaction and systemic reaction after second TBE booster vaccination in Study 700802 were reported in this outcome measure.
Time frame: From second booster vaccination up to 21-35 days after the vaccination
Population: The safety population included any participant who had received the second booster dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | Injection site reactions | 1 Participants |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | Systemic reactions | 0 Participants |
Secondary
Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
Seropositivity rate was reported as percentage of participants with ELISA level \>126 VIE U/mL at 21-35 days after second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.
Time frame: 21-35 days after second TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | 100.0 Percentage of participants |
Secondary
Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Seropositivity rate was reported as percentage of participants with ELISA level greater than (\>) 126 vienna units per milliliter (VIE U/mL) at each blood sampling time point after first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.
Time frame: 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination
Population: Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 21-35 days | 98.8 Percentage of participants |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 38 months | 97.0 Percentage of participants |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 46 months | 100.0 Percentage of participants |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 58 months | 97.5 Percentage of participants |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 70 months | 96.8 Percentage of participants |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 82 months | 96.2 Percentage of participants |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 94 months | 96.2 Percentage of participants |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 106 months | 91.7 Percentage of participants |
| FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | After 118 months | 87.7 Percentage of participants |