Trial Outcomes & Findings for Tick-Borne Encephalitis (TBE) Seropersistence After First Booster and Response to a Second Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401) (NCT NCT00894686)

NCT ID: NCT00894686

Last Updated: 2018-12-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 179 participants
• Primary outcome timeframe: 21-35 days after first TBE booster vaccination
• Results posted on: 2018-12-17

Participant Flow

This study is a follow-up study of 700401 (NCT00161967) in which participants received the first booster vaccination.

Participant milestones

Measure	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.
Overall Study STARTED	179
Overall Study COMPLETED	123
Overall Study NOT COMPLETED	56

Reasons for withdrawal

Measure	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.
Overall Study Withdrawal by Subject	50
Overall Study Physician Decision	1
Overall Study Other	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=179 Participants 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.
Age, Continuous	15.1 Years STANDARD_DEVIATION 4.4 • n=179 Participants
Sex: Female, Male Female	88 Participants n=179 Participants
Sex: Female, Male Male	91 Participants n=179 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=171 Participants 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.

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 Interval 97.9 to 100.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=167 Participants 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.

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 Interval 97.8 to 100.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=147 Participants 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.

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 Interval 97.5 to 100.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=156 Participants 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.

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 Interval 96.5 to 100.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=157 Participants 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.

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 Interval 94.5 to 99.6

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=156 Participants 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.

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 Interval 92.7 to 99.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=156 Participants 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.

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 Interval 91.0 to 98.2

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=156 Participants 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.

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 Interval 90.1 to 97.8

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=155 Participants 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.

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 Interval 84.5 to 94.5

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=26 Participants 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.

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 Interval 86.8 to 100.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=172 Participants 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.
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 Interval 95.8 to 99.9
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 Interval 93.1 to 99.0
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 Interval 97.5 to 100.0
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 Interval 93.6 to 99.3
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 Interval 92.7 to 99.0
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 Interval 91.8 to 98.6
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 Interval 91.8 to 98.6
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 Interval 86.2 to 95.5
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 Interval 81.5 to 92.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=26 Participants 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.

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 Interval 86.8 to 100.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=172 Participants 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.
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 Interval 3605.22 to 5292.63
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 Interval 933.04 to 1253.51
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 Interval 1055.77 to 1391.65
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 Interval 876.16 to 1153.08
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 Interval 767.09 to 1017.25
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 Interval 626.66 to 847.12
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 Interval 541.7 to 748.55
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 Interval 469.95 to 669.58
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 Interval 414.96 to 618.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=26 Participants 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.

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 Interval 1305.54 to 2604.91

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=172 Participants 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.
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 Interval 336.73 to 430.31
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 Interval 139.29 to 188.58
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 Interval 92.41 to 126.34
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 Interval 96.1 to 128.84
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 Interval 105.31 to 144.59
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 Interval 102.33 to 146.28
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 Interval 68.88 to 99.57
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 Interval 46.42 to 67.57
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 Interval 43.4 to 66.87

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=26 Participants 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.

Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

126.8 Titers Interval 94.76 to 169.64

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=26 Participants 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.

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 Interval 6.69 to 11.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=26 Participants 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.

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 Interval 2.78 to 9.67

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=26 Participants 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.
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
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

Adverse Events

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL n=26 participants at risk 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.

Infections and infestations Tenderness

3.8% 1/26 • From second booster vaccination up to 21-35 days after the vaccination The safety population included any participant who had received the second booster dose.

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER