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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00163618
Other study ID # 700501
Secondary ID
Status Completed
Phase Phase 4
First received September 8, 2005
Last updated May 20, 2015
Start date June 2005
Est. completion date July 2006

Study information

Verified date May 2015
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and Women
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Years to 11 Years
Eligibility 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

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Biological:
Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl


Locations

Country Name City State
Austria Bahnhofstraße 9 Hermagor
Austria Freistädter Strasse 290 Linz
Austria Conrad-von-Hoetzendorf-Strasse Voitsberg
Austria Grieskirchner Strasse 17 Wels

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Austria, 

See also
  Status Clinical Trial Phase
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Completed NCT00460486 - Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule Phase 3
Completed NCT00161824 - Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR Phase 3
Completed NCT00163540 - Immunogenicity and Safety Study of a Third Vaccination With FSME-IMMUN 0.5 mL in Subjects Previously Vaccinated According to a Rapid Immunization Schedule (Follow-up to Study 225) Phase 4
Completed NCT00161967 - TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209) Phase 4
Completed NCT00161876 - FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years Phase 3
Recruiting NCT03932448 - Fever After Tick Bite Study
Completed NCT00311441 - Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children Phase 4
Completed NCT00161954 - Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years Phase 4
Completed NCT00503529 - TBE Antibody Persistence and Booster Vaccination Study in Adults (Follow-up to Study 223) Phase 4
Completed NCT00840801 - Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children Phase 3
Completed NCT00452621 - Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years Phase 4
Completed NCT00311493 - Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults Phase 4
Completed NCT00161850 - FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years Phase 2
Completed NCT00161889 - FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years Phase 2
Completed NCT00894686 - 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) Phase 4
Completed NCT00161746 - Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years Phase 2/Phase 3