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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

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Bahnhofstraße 9
Hermagor, , 9620 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-borne Encephalitis
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

NCT00163618
Pfizer
Completed
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

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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
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
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.
Not Provided
Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Encephalitis, Tick-borne
Biological: Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
July 2006
Not Provided

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
Sexes Eligible for Study: All
7 Years to 11 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00163618
700501
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Principal Investigator: Baxter BioScience Investigator Baxter Healthcare Corporation
Pfizer
May 2015

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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