Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children

NCT00163618

Last updated date
Study Location
Bahnhofstraße 9
Hermagor, , 9620, Austria
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Encephalitis, Tick-borne
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
7-11 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female children who participated in Study 146A if:

- they and/or their parents/legal guardians understand the nature of the study and agree to its provisions

- written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians

- they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A

- they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects who received any further TBE vaccination since their first TBE booster
vaccination


- Subjects with a history of infection with, or vaccination against, other flaviviruses
(e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their
third vaccination in Study 146A


- Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone
a form of treatment (e.g. systemic corticosteroids) that can be expected to influence
immunological functions within 30 days before and after their first TBE booster
vaccination


- Subjects who have been known to be HIV positive (a special HIV test is not required
for the purpose of the study) since their third vaccination in Study 146A


- Subjects who have received a blood transfusion or immunoglobulins within 30 days of
study entry

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Advanced Information
Descriptive Information
Brief Title Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children
Official Title Multicenter Phase IV Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children
Brief Summary The objective of this study is to assess the TBE antibody persistence approximately three years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.
Detailed Description Not Provided
Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Encephalitis, Tick-borne
Intervention Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Enrollment Not Provided
Actual Study Completion Date July 2006
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Male and female children who participated in Study 146A if:
  • they and/or their parents/legal guardians understand the nature of the study and agree to its provisions
  • written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians
  • they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A
  • they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A

Exclusion Criteria:

  • Subjects who received any further TBE vaccination since their first TBE booster vaccination
  • Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A
  • Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination
  • Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A
  • Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry
Sex/Gender
Sexes Eligible for Study:All
Ages 7 Years to 11 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT00163618
Other Study ID Numbers 700501
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Principal Investigator:Baxter BioScience InvestigatorBaxter Healthcare Corporation
PRS Account Pfizer
Verification Date May 2015