Clinical Trial Results:
Open-label follow-up study to investigate the seropersistence of TBE antibodies and the booster response to a tick-borne encephalitis vaccine in children and adolescents aged 3 - 18 years.
Summary
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EudraCT number |
2005-000767-26 |
Trial protocol |
AT DE |
Global end of trial date |
25 Jul 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Jun 2016
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First version publication date |
30 Jul 2015
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Other versions |
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 |
700401
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00161967 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Alias: B9371020 | ||
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., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
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Scientific contact |
Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, 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? |
Yes
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Jul 2009
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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 |
25 Jul 2008
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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 24 months and 34 months after the third TBE vaccination with FSME-IMMUN 0.25 milliliter (mL), by means of Enzyme-Linked immunosorbent Assay (ELISA) (IMMUNOZYM FSME immunoglobulin G [IgG]) and neutralization test (NT).
To assess TBE antibody response to a booster vaccination with FSME-IMMUN 0.25 mL or FSME-IMMUN 0.5 mL administered 36 months after the third vaccination, by means of ELISA and NT.
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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 Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 May 2005
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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 |
Germany: 160
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Country: Number of subjects enrolled |
Austria: 79
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Country: Number of subjects enrolled |
Poland: 119
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Worldwide total number of subjects |
358
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EEA total number of subjects |
358
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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) |
59
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Children (2-11 years) |
220
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Adolescents (12-17 years) |
79
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Adults (18-64 years) |
0
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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 |
- | ||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
The study was carried out at 4 study sites in 3 European countries (Austria, Germany and Poland). It started on 09 May 2005 and completed on 25 Jul 2008. | ||||||||||||||||||||||||||||||||||||
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 | ||||||||||||||||||||||||||||||||||||
Arms
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Arm title
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3 or 4 Doses FSME-IMMUN | ||||||||||||||||||||||||||||||||||||
Arm description |
Subjects received primary immunization (3 vaccinations at 0, 1 and 6 Month with FSME-IMMUN 0.25 milliliter [mL]) in study 209 [NCT00161863] were offered a booster dose (4th dose) 3-, 4-, or 5-year after the third vaccination, depending on their TBE titers. Subjects with high TBE antibody levels (ELISA greater than [>] 1000 Vienna Units per milliliter [VIE U/ml] and positive NT result) at 24, 34, 46, and/or 58 months after the third vaccination were not to receive the 4th dose. | ||||||||||||||||||||||||||||||||||||
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 |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received a booster dose (4th dose) of FSME-IMMUN 0.25 mL (age less than [<] 16 years) or 0.5 mL (age greater than or equal to [>=] 16 years old) 3-, 4-, or 5-years after the third vaccination in study 209 if the TBE antibody level was ELISA <= 1000 VIE U/mL or negative NT results at 24, 34, 46, and/or 58 months after the third vaccination from study 209.
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Notes [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Not all subjects who enrolled in this study, received a booster vaccination. Subjects with high TBE antibody levels (ELISA >1000 VIE U/ml and positive NT result) at 24, 34, 46, and/or 58 months after the third vaccination did not received the 4th dose. [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Not all subjects who enrolled in this study, received a booster vaccination. Subjects with high TBE antibody levels (ELISA >1000 VIE U/ml and positive NT result) at 24, 34, 46, and/or 58 months after the third vaccination did not received the 4th dose. [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Not all subjects who enrolled in this study, received a booster vaccination. Subjects with high TBE antibody levels (ELISA >1000 VIE U/ml and positive NT result) at 24, 34, 46, and/or 58 months after the third vaccination did not received the 4th dose. |
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Baseline characteristics reporting groups
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Reporting group title |
3 or 4 Doses FSME-IMMUN
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Reporting group description |
Subjects received primary immunization (3 vaccinations at 0, 1 and 6 Month with FSME-IMMUN 0.25 milliliter [mL]) in study 209 [NCT00161863] were offered a booster dose (4th dose) 3-, 4-, or 5-year after the third vaccination, depending on their TBE titers. Subjects with high TBE antibody levels (ELISA greater than [>] 1000 Vienna Units per milliliter [VIE U/ml] and positive NT result) at 24, 34, 46, and/or 58 months after the third vaccination were not to receive the 4th dose. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
3 or 4 Doses FSME-IMMUN
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Reporting group description |
Subjects received primary immunization (3 vaccinations at 0, 1 and 6 Month with FSME-IMMUN 0.25 milliliter [mL]) in study 209 [NCT00161863] were offered a booster dose (4th dose) 3-, 4-, or 5-year after the third vaccination, depending on their TBE titers. Subjects with high TBE antibody levels (ELISA greater than [>] 1000 Vienna Units per milliliter [VIE U/ml] and positive NT result) at 24, 34, 46, and/or 58 months after the third vaccination were not to receive the 4th dose. |
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End point title |
Seropositivity Rate Measured by ELISA and/or NT According to Adner et al., 2001 at 1 Month After the Third Vaccination in Study 209 by First Dose Age Group [1] | ||||||||||||||||
End point description |
Proportion of subjects with ELISA >126 VIE U/mL or NT >=10. Here, 'N' signifies those subjects who were evaluable within the specified age group in study 209.
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End point type |
Primary
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End point timeframe |
1 month after the third vaccination in study 209
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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 statistics (95% CI) were planned, no formal hypothesis testing analysis performed. |
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No statistical analyses for this end point |
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End point title |
Seropositivity Rate Measured by ELISA and/or NT According to Adner et al., 2001 at 24 Months After the Third Vaccination in Study 209 by First Dose Age Group [2] | ||||||||||||||||
End point description |
Proportion of subjects with ELISA >126 VIE U/mL or NT >=10. Here, 'N' signifies those subjects who were evaluable within the specified age group in study 209.
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End point type |
Primary
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End point timeframe |
24 months after the third vaccination in study 209
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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 statistics (95% CI) were planned, no formal hypothesis testing analysis performed. |
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No statistical analyses for this end point |
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End point title |
Seropositivity Rate Measured by ELISA and/or NT According to Adner et al., 2001 at 34 Months After the Third Vaccination in Study 209 by First Dose Age Group [3] | ||||||||||||||||
End point description |
Proportion of subjects with ELISA >126 VIE U/mL or NT >=10. Here, 'N' signifies those subjects who evaluable within the specified age group in study 209.
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End point type |
Primary
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End point timeframe |
34 months after the third vaccination in study 209
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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 statistics (95% CI) were planned, no formal hypothesis testing analysis performed. |
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No statistical analyses for this end point |
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End point title |
Seropositivity Rate Measured by ELISA and/or NT According to Adner et al., 2001 at 46 Months After the Third Vaccination in Study 209 by First Dose Age Group [4] | ||||||||||||||||
End point description |
Proportion of subjects with ELISA >126 VIE U/mL or NT >=10. Here, 'N' signifies those subjects who were evaluable within the specified age group in study 209.
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End point type |
Primary
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End point timeframe |
46 months after the third vaccination in study 209
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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 statistics (95% CI) were planned, no formal hypothesis testing analysis performed. |
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No statistical analyses for this end point |
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End point title |
Seropositivity Rate Measured by ELISA and/or NT According to Adner et al., 2001 at 58 Months After the Third Vaccination in Study 209 by First Dose Age Group [5] | ||||||||||||||||
End point description |
Proportion of subjects with ELISA >126 VIE U/mL or NT >=10. Here, 'N' signifies those subjects who were evaluable within the specified age group in study 209.
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End point type |
Primary
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End point timeframe |
58 months after the third vaccination in study 209
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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 statistics (95% CI) were planned, no formal hypothesis testing analysis performed. |
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No statistical analyses for this end point |
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End point title |
Seropositivity Rate Measured by ELISA and/or NT According to Adner et al., 2001 After the 36 Month Booster Vaccination in this Study by First Dose Age Group [6] | ||||||||||||||||
End point description |
Proportion of subjects with ELISA >126 VIE U/mL or with NT >=10 among subjects who received Booster Vaccination at Month 36. Full analysis dataset included subjects who received a booster vaccination at 36 Month after the third vaccination in the study 209, and with assay results 21-35 days after the booster vaccination. Here, 'N' signifies those subjects who received the corresponding booster vaccination at Month 36 and were evaluable within the specified age group in study 209.
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End point type |
Primary
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End point timeframe |
21-35 days after 36-month booster dose
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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 statistics (95% CI) were planned, no formal hypothesis testing analysis performed. |
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No statistical analyses for this end point |
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End point title |
Seropositivity Rate Measured by ELISA and/or NT According to Adner et al., 2001 After the 48 Month Booster Vaccination in this Study by First Dose Age Group [7] | ||||||||||||||||
End point description |
Proportion of subjects with ELISA >126 VIE U/mL or with NT >=10 among subjects who received Booster Vaccination at Month 48. Full analysis dataset included subjects who received a booster vaccination at 48 Month after the third vaccination in the study 209, and with assay results 21-35 days after the booster vaccination. Here, 'N' signifies those subjects who received the corresponding booster vaccination at Month 48 and were evaluable within the specified age group in study 209.
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End point type |
Primary
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End point timeframe |
21-35 days after 48-month booster dose
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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 statistics (95% CI) were planned, no formal hypothesis testing analysis performed. |
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No statistical analyses for this end point |
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End point title |
Seropositivity Rate Measured by ELISA and/or NT According to Adner et al., 2001 After the 60 Month Booster Vaccination in this Study by First Dose Age Group [8] | ||||||||||
End point description |
Proportion of subjects with ELISA >126 VIE U/mL or with NT >=10 among subjects who received Booster Vaccination at Month 60. Full analysis dataset included subjects who received a booster vaccination at 60 Month after the third vaccination in the study 209, and with assay results 21-35 days after the booster vaccination. Here, 'N' signifies the subjects who received the corresponding booster vaccination at Month 60 and were evaluable within the specified age group in study 209.
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End point type |
Primary
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End point timeframe |
21-35 days after 60-month booster dose
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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 statistics (95% CI) were planned, no formal hypothesis testing analysis performed. |
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No statistical analyses for this end point |
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End point title |
Seropositivity Rate Measured by ELISA at Each Available Time Point After the Third Vaccination in the Study 209 by First Dose Age Group | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Proportion of subjects with ELISA concentrations >126 VIE U/mL and 95% confidence interval (CI) were presented. Results were summarized for the applicable categories based on the time point of assessment, dose of FSME-IMMUN received in current study (0.25 mL and 0.5 mL) and age of the subject at first vaccination in study 209: 1-2 years, 3-6 years, 7-15 years, and 12-15 years. Here, 'N' signifies subjects of the mentioned combination of timepoint/age group in study 209/booster dose.
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End point type |
Secondary
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End point timeframe |
1, 24, 34, 46, 58 months after the third vaccination in study 209; 21-35 days after 36-, 48- or 60-month booster dose
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No statistical analyses for this end point |
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End point title |
Seropositivity Rate Measured by NT According to Adner et al., 2001 at Each Available Time Point After the Third Vaccination in the Study 209 by First Dose Age Group | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Proportion of subjects with NT titer >=10 and 95% CI were presented. Results were summarized for the applicable categories based on the time point of assessment, dose of FSME-IMMUN received in current study (0.25 mL and 0.5 mL) and age of the subject at first vaccination in study 209: 1-2 years, 3-6 years, 7-15 years, and 12-15 years. Here, 'N' signifies subjects of the mentioned combination of timepoint/age group in study 209/booster dose.
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End point type |
Secondary
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End point timeframe |
1, 24, 34, 46, 58 months after the third vaccination in study 209; 21-35 days after 36-, 48- or 60-month booster dose
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No statistical analyses for this end point |
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End point title |
Geometric Mean Antibody Concentration (GMC) as Measured by ELISA at Each Available Time Point After the Third Vaccination in the Study 209 by First Dose Age Group | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibody GMC for TBE as measured by ELISA for subjects presented. GMC and corresponding 2-sided 95% CIs were evaluated. Results were summarized for the applicable categories based on the time point of assessment, dose of FSME-IMMUN received in current study (0.25 mL and 0.5 mL) and age of the subject at first vaccination in study 209: 1-2 years, 3-6 years, 7-15 years, and 12-15 years. Here -99999 and 99999 indicates lower and upper limit of CI. CI was not estimable as number of subjects evaluable for 60-Month booster dose was 1. Here, 'N' signifies subjects of the mentioned combination of timepoint/age group in study 209/booster dose.
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End point type |
Secondary
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End point timeframe |
1, 24, 34, 46, 58 months after the third vaccination in study 209; 21-35 days after 36-, 48- or 60-month booster dose
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No statistical analyses for this end point |
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End point title |
Geometric Mean Antibody Titer (GMT) as Measured by NT According to Adner et al., 2001 at Each Available Time Point After the Third Vaccination in the Study 209 by First Dose Age Group | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
GMT for NT and corresponding 2-sided 95% CIs were evaluated. Results were summarized for the applicable categories based on the time point of assessment, dose of FSME-IMMUN received in current study (0.25 mL and 0.5 mL) and age of the subject at first vaccination in study 209: 1-2 years, 3-6 years, 7-15 years, and 12-15 years. Here, -99999 and 99999 indicates lower and upper limit of CI. CI was not estimable as number of subjects evaluable for 60-Month booster dose was 1. Here, 'N' signifies subjects of the mentioned combination of timepoint/age group in study 209/booster dose.
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End point type |
Secondary
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End point timeframe |
1, 24, 34, 46, 58 months after the third vaccination in study 209; 21-35 days after 36-, 48- or 60-month booster dose
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No statistical analyses for this end point |
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End point title |
Geometric Mean of Fold Increase in Antibody Concentrations After the Booster Vaccination as Compared to Before the Booster Vaccination as Measured by ELISA by First Dose Age Group | ||||||||||||||||||||||||||
End point description |
Geometric mean of fold increase in TBE antibody concentrations as measured by ELISA and 95% CIs were evaluated. Results were summarized for the applicable categories based on the dose and timepoint of FSME-IMMUN received and age of the subject at first vaccination: 1-2 years, 3-6 years, 7-15 years. Here, -99999 and 99999 indicates lower and upper limit of CI. It was not estimable as the number of subjects evaluable for 60 Month booster dose was 1. Full analysis dataset included subjects who received a booster vaccination at 36-, 48- or 60-Month after the third vaccination in the study 209, and with assay results 21-35 days after the booster vaccination. Here, 'N' signifies subjects of the mentioned combination of timepoint/age group in study 209/booster dose.
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End point type |
Secondary
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End point timeframe |
From before booster dose to 21-35 days after 36-, 48- or 60-month booster dose
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No statistical analyses for this end point |
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End point title |
Geometric Mean of Fold Increase in Antibody Titer After the Booster Vaccination as Compared to Before the Booster Vaccination Measured by NT According to Adner et al., 2001 by First Dose Age Group | ||||||||||||||||||||||||||
End point description |
Geometric mean of fold increase in TBE antibody titer as measured by NT and 95% CIs were evaluated. Results were summarized for the applicable categories based on the dose and timepoint of FSME-IMMUN received and age of the subject at first vaccination: 1-2 years, 3-6 years, 7-15 years. Here, -99999 and 99999 indicates lower and upper limit of CI. It was not estimable as the number of subjects evaluable for 60-Month booster dose was 1. Full analysis dataset included subjects who received a booster vaccination at 36-, 48- or 60-Month after the third vaccination in the study 209, and with assay results 21-35 days after the booster vaccination. Here, 'N' signifies subjects of the mentioned combination of timepoint/age group in study 209/booster dose.
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End point type |
Secondary
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End point timeframe |
From before booster dose to 21-35 days after 36-, 48- or 60-month booster dose
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No statistical analyses for this end point |
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End point title |
Seropositivity Rate Measured by NT according to Holzmann et al., 1996 at Each Available Time Point After the Third Vaccination in the Study 209 by First Dose Age Group | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Proportion of subjects with NT100 titers >=10 and NT50 titers >10 and 95% CIs were presented. Results were summarized for the applicable categories based on the time point of assessment, dose of FSME-IMMUN received in current study (0.25 mL and 0.5 mL) and age of the subject at first vaccination in study 209: 1-2 years, 3-6 years, 7-15 years, and 12-15 years. Here, 'N' signifies subjects of the mentioned combination of timepoint/age group in study 209/booster dose.
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End point type |
Secondary
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End point timeframe |
24, 34 month after the third vaccination in study 209; 21-35 days after the 36-, 48- or 60-month booster dose
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No statistical analyses for this end point |
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End point title |
Geometric Mean Antibody Titer (GMT) as Measured by NT According to Holzmann et al., 1996 at Each Available Time Point After the Third Vaccination in the Study 209 by First Dose Age Group | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
GMT for NT and corresponding 2-sided 95% CIs were evaluated. NT100 titers and NT50 titers were presented. Results were summarized for the applicable categories based on the dose and timepoint of FSME-IMMUN received and age of the subject at first vaccination: 1-2 years, 3-6 years, 7-15 years and 12-15 years. Here, -99999 and 99999 indicates lower and upper limit of CI. It was not estimable as number of subjects evaluable for 60-Month booster dose was 1. Here, 'N' signifies subjects of the mentioned combination of timepoint/age group in study 209/booster dose.
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End point type |
Secondary
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End point timeframe |
24, 34 months after the third vaccination in study 209; 21-35 days after 36-, 48- or 60-month booster dose
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No statistical analyses for this end point |
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End point title |
Geometric Mean of Fold Increase in Antibody Titer After the Booster Vaccination as Compared to Before the Booster Vaccination Measured by NT According to Holzmann et al., 1996 by First Dose Age Group | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Geometric mean of fold increase in TBE antibody titer after the booster vaccination as compared to before the booster vaccination as measured by NT according to Holzmann et al., 1996 and 95% CIs were evaluated. Results were summarized for the applicable categories based on the dose and timepoint of FSME-IMMUN received and age of the subject at first vaccination: 1-2 years, 3-6 years, 7-15 years. Here, -99999 and 99999 indicates lower and upper limit of CI. It was not estimable as the number of subjects evaluable for 60-Month booster dose was 1. Full analysis dataset included subjects who received a booster vaccination at 36-, 48- or 60-Month after the third vaccination in the study 209, and with assay results 21-35 days after the booster vaccination. Here, 'N' signifies subjects of the mentioned combination of timepoint/age group in study 209/booster dose.
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End point type |
Secondary
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End point timeframe |
From before booster dose to 21-35 days after 36-, 48- or 60-month booster dose
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Fever After 36 Month, 48 Month and 60 Month Booster Vaccination | ||||||||||||||||||
End point description |
Proportion of subjects with fever >=38.0 degrees Celsius (C) and their 95% CIs were presented according to the booster dose. Subject his/her parent/legal guardian were asked to carefully monitor for fever and therefore, to measure the body temperature orally or rectally (optional for small children) in the evening of the vaccination day, on the following morning, and in the evening each day for 3 days following the booster vaccination (altogether 4 days). All measured temperatures, including the first day without fever and the method used (oral or rectal), were to be documented in the subject diary. Full analysis dataset included subjects who received a booster vaccination at 36-, 48- or 60-Month after the third vaccination in study 209. Here, 'N' signifies subjects of the mentioned combination of timepoint and booster dose in this study.
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End point type |
Secondary
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End point timeframe |
Within 4 days after 36-, 48- or 60-month booster dose
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Local and Systemic Reactions After 36 Month, 48 Month and 60 Month Booster Vaccination | ||||||||||||||||||||||||||||
End point description |
Proportion of subjects with local reactions (LR) and systemic reactions (SR) (other than fever) after the 36 Month, 48 Month or 60 Month booster dose and 95% CIs were presented according to the booster dose. Local reactions included: swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma. Systemic symptoms including headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite, changes in sleeping behavior, fatigue and malaise were to be monitored and documented in the subject diary. Full analysis dataset included subjects who received a booster vaccination at 36 Month, 48 Month, or 60 Month after the third vaccination in study 209. Here, 'N' signifies subjects of the mentioned combination of 4th vaccination dose level, timepoint, and endpoints.
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End point type |
Secondary
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End point timeframe |
Within 4 days after 36-, 48- or 60-month booster dose
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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 |
Adverse events (AEs)/serious AEs recorded through 21 to 35 days after the booster dose. LR and SR were recorded within 4 days after the booster vaccination in a subject diary.
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Adverse event reporting additional description |
SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in subject diary (local and systemic reactions for FSME-IMMUN) and AEs collected on case report form at each visit (non-systematic assessment).
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
8.1
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Reporting groups
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Reporting group title |
3 or 4 Doses FSME-IMMUN
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Reporting group description |
Subjects received primary immunization (3 vaccinations at 0, 1 and 6 Month with FSME-IMMUN 0.25 mL) in study 209 [NCT00161863] were offered a booster dose (4th dose) 3-, 4-, or 5-year after the third vaccination, depending on their TBE titers. Subjects with high TBE antibody levels (ELISA > 1000 VIE U/ml and positive NT result) at 24, 34, 46, and/or 58 months after the third vaccination were not to receive the 4th dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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30 Oct 2006 |
The clinical study was prolonged for children and adolescents who still showed highly positive TBE virus antibody concentrations as determined by ELISA (>1000 VIE U/mL) and positive NT titers (>=10) at approximately 3 years after the third vaccination. The protocol was amended to include further follow-up of TBE antibody persistence at 46 and 58 months after the third vaccination, as well as a booster vaccination offered at either Month 48 or Month 60 after the third vaccination in study 209, depending on individual TBE antibody levels. A total of 172 subjects who had not received the first booster vaccination at Month 36 after the third vaccination in study 209 were invited for this study prolongation. The extension was introduced to investigate seropersistence beyond 3 years and consequently to obtain clinical data to identify the optimal booster interval for FSME-IMMUN 0.25 mL. |
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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 |