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Trial record 3 of 7 for:    "Encephalitis" | "Pharmaceutical Solutions"

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)

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ClinicalTrials.gov Identifier: NCT00894686
Recruitment Status : Completed
First Posted : May 7, 2009
Results First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Encephalitis, Tick-Borne
Intervention Biological: FSME-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)
Enrollment 179
Recruitment Details  
Pre-assignment Details This study is a follow-up study of 700401 (NCT00161967) in which participants received the first booster vaccination.
Arm/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 179
Completed 123
Not Completed 56
Reason Not Completed
Withdrawal by Subject             50
Physician Decision             1
Other             5
Arm/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description 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 Number of Baseline Participants 179
Hide Baseline Analysis Population Description
Full analysis set included all participants enrolled into the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 179 participants
15.1  (4.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 179 participants
Female
88
  49.2%
Male
91
  50.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 171
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100.0
(97.9 to 100.0)
2.Primary Outcome
Title Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 167
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100.0
(97.8 to 100.0)
3.Primary Outcome
Title Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100.0
(97.5 to 100.0)
4.Primary Outcome
Title Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 156
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
99.4
(96.5 to 100.0)
5.Primary Outcome
Title Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 157
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
98.1
(94.5 to 99.6)
6.Primary Outcome
Title Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 156
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
96.8
(92.7 to 99.0)
7.Primary Outcome
Title Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 156
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
95.5
(91.0 to 98.2)
8.Primary Outcome
Title Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 156
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
94.9
(90.1 to 97.8)
9.Primary Outcome
Title Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 155
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
90.3
(84.5 to 94.5)
10.Primary Outcome
Title Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100.0
(86.8 to 100.0)
11.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 172
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
After 21-35 days Number Analyzed 171 participants
98.8
(95.8 to 99.9)
After 38 months Number Analyzed 166 participants
97.0
(93.1 to 99.0)
After 46 months Number Analyzed 146 participants
100.0
(97.5 to 100.0)
After 58 months Number Analyzed 157 participants
97.5
(93.6 to 99.3)
After 70 months Number Analyzed 156 participants
96.8
(92.7 to 99.0)
After 82 months Number Analyzed 156 participants
96.2
(91.8 to 98.6)
After 94 months Number Analyzed 156 participants
96.2
(91.8 to 98.6)
After 106 months Number Analyzed 156 participants
91.7
(86.2 to 95.5)
After 118 months Number Analyzed 155 participants
87.7
(81.5 to 92.5)
12.Secondary Outcome
Title Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100.0
(86.8 to 100.0)
13.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 172
Geometric Mean (95% Confidence Interval)
Unit of Measure: VIE U/mL
After 21-35 days Number Analyzed 171 participants
4368.2
(3605.22 to 5292.63)
After 38 months Number Analyzed 166 participants
1081.5
(933.04 to 1253.51)
After 46 months Number Analyzed 146 participants
1212.1
(1055.77 to 1391.65)
After 58 months Number Analyzed 157 participants
1005.1
(876.16 to 1153.08)
After 70 months Number Analyzed 156 participants
883.4
(767.09 to 1017.25)
After 82 months Number Analyzed 156 participants
728.6
(626.66 to 847.12)
After 94 months Number Analyzed 156 participants
636.8
(541.70 to 748.55)
After 106 months Number Analyzed 156 participants
561.0
(469.95 to 669.58)
After 118 months Number Analyzed 155 participants
506.4
(414.96 to 618.10)
14.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 26
Geometric Mean (95% Confidence Interval)
Unit of Measure: VIE U/mL
1844.1
(1305.54 to 2604.91)
15.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 172
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
After 21-35 days Number Analyzed 171 participants
380.7
(336.73 to 430.31)
After 38 months Number Analyzed 167 participants
162.1
(139.29 to 188.58)
After 46 months Number Analyzed 147 participants
108.1
(92.41 to 126.34)
After 58 months Number Analyzed 156 participants
111.3
(96.10 to 128.84)
After 70 months Number Analyzed 157 participants
123.4
(105.31 to 144.59)
After 82 months Number Analyzed 156 participants
122.3
(102.33 to 146.28)
After 94 months Number Analyzed 156 participants
82.8
(68.88 to 99.57)
After 106 months Number Analyzed 156 participants
56.0
(46.42 to 67.57)
After 118 months Number Analyzed 155 participants
53.9
(43.40 to 66.87)
16.Secondary Outcome
Title Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 26
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
126.8
(94.76 to 169.64)
17.Secondary Outcome
Title 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)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
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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 Number of Participants Analyzed 26
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold rise
8.6
(6.69 to 11.10)
18.Secondary Outcome
Title 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)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 26
Geometric Mean (95% Confidence Interval)
Unit of Measure: Fold rise
5.2
(2.78 to 9.67)
19.Secondary Outcome
Title Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
Hide Description 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
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Hide Analysis Population Description
The safety population included any participant who had received the second booster dose.
Arm/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description:
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 Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: Participants
Injection site reactions 1
Systemic reactions 0
Time Frame From second booster vaccination up to 21-35 days after the vaccination
Adverse Event Reporting Description The safety population included any participant who had received the second booster dose.
 
Arm/Group Title FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Hide Arm/Group Description 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.
All-Cause Mortality
FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Affected / at Risk (%)
Total   0/26 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Affected / at Risk (%)
Total   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Affected / at Risk (%)
Total   1/26 (3.85%) 
Infections and infestations   
Tenderness * 1  1/26 (3.85%) 
1
Term from vocabulary, MedDRA v19.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00894686     History of Changes
Other Study ID Numbers: 700802
B9371021 ( Other Identifier: Alias Study Number )
2009-009324-36 ( EudraCT Number )
First Submitted: April 30, 2009
First Posted: May 7, 2009
Results First Submitted: May 9, 2018
Results First Posted: December 17, 2018
Last Update Posted: December 17, 2018