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NCT00311441 Clinical Trial

Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy Children

Encephalitis, Tick-Borne Clinical Trial

Official title:
A Phase IV, Randomized, Controlled, Single-Blind, Multi-Center Study in Children to Evaluate the Safety, Tolerability and Immunogenicity of Two TBE Vaccines Administered According to Two Different Schedules.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00311441
Other study ID # M48P3
Secondary ID 911
Status Completed
Phase Phase 4
First received April 3, 2006
Last updated March 14, 2008
Start date March 2005

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

Clinical Trial Summary

The purpose of this study is to evaluate the safety, immunogenicity and tolerability of TBE vaccines administered to children.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 10 Years
Eligibility Inclusion Criteria:

- Healthy male and female children, 1 to 10 years of age.

Exclusion Criteria:

- Subjects with documented evidence of TBE

- Subjects, who have been previously vaccinated against TBE

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Tick-Borne Encephalitis vaccine

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Vaccines

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immunogenicity of two pediatric TBE vaccines as measured by neutralization test and ELISA on days 28, 42, 300, and 321.
Secondary Tolerability of two paediatric TBE vaccines with respect to local and systemic reactions including fever
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 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 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