Clinical Trial Results:
Open-label Phase IV Study to Investigate the Seropersistence of Tick-borne Encephalitis (TBE) Virus Antibodies After the First Booster and the Response to A Second Booster Vaccination With Fsme-Immun in Children, Adolescents and Young Adults (Follow Up to Study 700401)
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Summary
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EudraCT number |
2009-009324-36 |
Trial protocol |
AT DE PL |
Global end of trial date |
10 May 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Nov 2017
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First version publication date |
18 Nov 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
700802
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00894686 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Pfizer, Inc.
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Sponsor organisation address |
235 E 42nd Street, New York, United States, NY 10017
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Public contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 011 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
16 Aug 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
10 May 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess tick-borne encephalitis (TBE) antibody persistence at yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination (as applicable) with either FSME-IMMUN 0.25 milliliters (mL) Junior or FSME-IMMUN 0.5 mL by means of neutralization test (NT) and enzyme-linked immunosorbent assay (ELISA) [IMMUNOZYM FSME Immunoglobulin G (IgG)].
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Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Apr 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 33
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Country: Number of subjects enrolled |
Germany: 73
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Country: Number of subjects enrolled |
Poland: 73
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Worldwide total number of subjects |
179
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EEA total number of subjects |
179
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
40
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Adolescents (12-17 years) |
80
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Adults (18-64 years) |
59
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||
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Pre-assignment
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Screening details |
This study is a follow-up study of 700401 (NCT00161967) in which subjects received the single booster vaccination. | ||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
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Arms
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Arm title
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FSME-IMMUN 0.25 milliliters (mL) Junior/0.5 mL | ||||||||||||||
Arm description |
Subjects 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. Subjects were followed up to 21-35 days post vaccination in this study. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
FSME-IMMUN
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects 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. Subjects were followed up to 21-35 days post vaccination in this study.
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Baseline characteristics reporting groups
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Reporting group title |
FSME-IMMUN 0.25 milliliters (mL) Junior/0.5 mL
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Reporting group description |
Subjects 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. Subjects were followed up to 21-35 days post vaccination in this study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
FSME-IMMUN 0.25 milliliters (mL) Junior/0.5 mL
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Reporting group description |
Subjects 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. Subjects were followed up to 21-35 days post vaccination in this study. | ||
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End point title |
Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 [1] | ||||||||
End point description |
Seropositivity rate was reported as percentage of subjects 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 subjects. Per-protocol population included subjects 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 subjects analyzed" (N) signifies those subjects who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
21-35 days after first TBE booster vaccination
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: only descriptive data was planned to be analysed for this endpoint |
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End point title |
Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 [2] | ||||||||
End point description |
Seropositivity rate was reported as percentage of subjects with NT level >=10 at 38 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of subjects. Per-protocol population included subjects 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 subjects who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
38 months after first TBE booster vaccination
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: only descriptive data was planned to be analysed for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 [3] | ||||||||
End point description |
Seropositivity rate was reported as percentage of subjects 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 subjects. Per-protocol population included subjects 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 subjects who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
46 months after first TBE booster vaccination
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: only descriptive data was planned to be analysed for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 [4] | ||||||||
End point description |
Seropositivity rate was reported as percentage of subjects 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 subjects. Per-protocol population included subjects 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 subjects who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
58 months after first TBE booster vaccination
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: only descriptive data was planned to be analysed for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 [5] | ||||||||
End point description |
Seropositivity rate was reported as percentage of subjects 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 subjects. Per-protocol population included subjects 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 subjects who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
70 months after first TBE booster vaccination
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: only descriptive data was planned to be analysed for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 [6] | ||||||||
End point description |
Seropositivity rate was reported as percentage of subjects 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 subjects. Per-protocol population included subjects 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 subjects who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
82 months after first TBE booster vaccination
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: only descriptive data was planned to be analysed for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 [7] | ||||||||
End point description |
Seropositivity rate was reported as percentage of subjects 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 subjects. Per-protocol population included subjects 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 subjects who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
94 months after first TBE booster vaccination
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: only descriptive data was planned to be analysed for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 [8] | ||||||||
End point description |
Seropositivity rate was reported as percentage of subjects 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 subjects. Per-protocol population included subjects 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 subjects who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
106 months after first TBE booster vaccination
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: only descriptive data was planned to be analysed for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 [9] | ||||||||
End point description |
Seropositivity rate was reported as percentage of subjects 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 subjects. Per-protocol population included subjects 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 subjects who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
118 months after first TBE booster vaccination
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| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: ionly descriptive data was planned to be analysed for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 [10] | ||||||||
End point description |
Seropositivity rate was reported as percentage of subjects 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 subjects. Per-protocol population included subjects 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.
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End point type |
Primary
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End point timeframe |
21-35 days after second TBE booster vaccination
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: only descriptive data was planned to be analysed for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point 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 | ||||||||||||||||||||||||||
End point description |
Seropositivity rate was reported as percentage of subjects 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 subjects. Per-protocol population included subjects 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 number of subjects who were evaluable at specified time points.
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End point type |
Secondary
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End point timeframe |
21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point 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 | ||||||||
End point description |
Seropositivity rate was reported as percentage of subjects 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 subjects. Per-protocol population included subjects 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.
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End point type |
Secondary
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End point timeframe |
21-35 days after second TBE booster vaccination
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| No statistical analyses for this end point | |||||||||
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End point 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 | ||||||||||||||||||||||||||
End point 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. Per-protocol population included subjects 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 number of subjects who were evaluable at specified time points.
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End point type |
Secondary
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End point timeframe |
21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point 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 | ||||||||
End point 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. Per-protocol population included subjects 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.
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End point type |
Secondary
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End point timeframe |
21-35 days after second TBE booster vaccination
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| No statistical analyses for this end point | |||||||||
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End point 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 | ||||||||||||||||||||||||||
End point 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. Per-protocol population included subjects 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 number of subjects who were evaluable at specified time points.
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End point type |
Secondary
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End point timeframe |
21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | ||||||||
End point 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. Per-protocol population included subjects 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.
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End point type |
Secondary
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End point timeframe |
21-35 days after second TBE booster vaccination
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| No statistical analyses for this end point | |||||||||
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End point 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) | ||||||||
End point 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. Per-protocol population included subjects 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.
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End point type |
Secondary
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End point timeframe |
Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination
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| No statistical analyses for this end point | |||||||||
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End point 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) | ||||||||
End point 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. Per-protocol population included subjects 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.
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End point type |
Secondary
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End point timeframe |
Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | ||||||||||
End point 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. Subjects with any injection site reaction and systemic reaction after second TBE booster vaccination in Study 700802 were reported in this outcome measure. The safety population included any subject who had received the second booster dose.
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End point type |
Secondary
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End point timeframe |
From second booster vaccination up to 21-35 days after the vaccination
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| No statistical analyses for this end point | |||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From second booster vaccination up to 21-35 days after the vaccination
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Adverse event reporting additional description |
The safety population included any subject who had received the second booster dose.
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Assessment type |
Non-systematic | ||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||
Dictionary version |
19.1
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Reporting groups
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Reporting group title |
FSME-IMMUN 0.25 milliliters (mL) Junior/0.5 mL
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Reporting group description |
Subjects 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. Subjects were followed up to 21-35 days post vaccination in this study. | ||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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07 Sep 2011 |
Additional blood draw visits at yearly intervals up to 10 years (118 months) after the first booster vaccination (as applicable) was introduced. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
