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NCT00161746 Clinical Trial

Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years

Encephalitis, Tick-borne Clinical Trial

Official title:
Multicentre Randomized Double-Blind Phase II/III Study on the Safety and Immunogenicity of Three Vaccinations With TICOVAC in Two Dosages in Healthy Children Aged Between Six Months and Three Years

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00161746
Other study ID # 146A
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 8, 2005
Last updated May 20, 2015
Start date April 1998
Est. completion date June 1999

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 Interventional

Clinical Trial Summary

The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date June 1999
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 47 Months
Eligibility Inclusion Criteria:

- Male and female children aged between 6 and 47 months

- No history of any previous TBE vaccination

- Clinically healthy

- Informed consent provided by the parents

Exclusion Criteria:

- History of allergic reactions, in particular allergic reactions to one of the components of the vaccine

- Suffering from a disease that cannot be effectively treated or stabilised

- Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions

- Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system

- HIV-positivity (no special HIV test required for the purpose of the study)

- Suffering from a febrile disease

- History of vaccination against yellow fever and/or Japanese encephalitis

- Participation in another clinical trial

Study Design

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

Related Conditions & MeSH terms

Intervention

Biological:
• Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Locations
Country Name City State
Austria Wiener Strasse 50/2 Kapfenberg
Austria Erzherzog Johann Strasse 9 Leoben
Austria Fronleichnamsweg 10 Liezen
Austria Hauptstrasse 61 Linz
Austria Brauhausgasse 1 Mürzzuschlag
Austria Conrad-von-Hötzendorf 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
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 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