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NCT00452621 Clinical Trial

Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years

Encephalitis, Tick-Borne Clinical Trial

Official title:
A Phase IV, Uncontrolled, Open-Label, Multi-Center Study in Children and Adolescents: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New Pediatric TBE Vaccine (Free of Protein-Derived Stabilizer) in Study V48P4E1, Five Years After First Booster Immunization

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00452621
Other study ID # V48P4E3
Secondary ID
Status Completed
Phase Phase 4
First received March 26, 2007
Last updated April 22, 2008
Start date February 2007

Study information
Verified date April 2008
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Germany:Paul-Ehrlich-Institute
Study type Interventional

Clinical Trial Summary

blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children

Recruitment information / eligibility
Status Completed
Enrollment 235
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 16 Years
Eligibility Inclusion Criteria:

- Healthy volunteers of both sexes aged >1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign informed consent.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• blood draw

Locations
Country Name City State
Germany Center 7 Aschaffenburg
Germany Center 2 Bobingen
Germany Center 11 Eberbach /Neckar
Germany Center 4 Kaufering
Germany Center 15 Pegnitz
Germany Center 1 Weilheim i. OB
Germany Center 8 Wiesloch
Germany Center 16 Zirndorf

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Vaccines

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) with respect to antibody titers in terms of:· percentage
Secondary (2) To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization) and V48P4E2 (serological follow-up) in terms of:· percentage of subjects with antibody conce
See also
  Status Clinical Trial Phase
Terminated NCT01031537 - Vaccine Study for Tick-Borne Encephalitis Virus (TBEV) Phase 2
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 NCT00161967 - TBE Antibody Persistence and Booster Vaccination Study in Children and Adolescents (Follow-up to Study 209) Phase 4
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 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 NCT00163618 - 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 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 NCT00311493 - Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults Phase 4
Completed NCT00161889 - FSME IMMUN NEW Follow-up to Study 205 in Children Aged 6 to 16 Years Phase 2
Completed NCT00161850 - FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 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