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NCT00161850 Clinical Trial

FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years

Encephalitis, Tick-borne Clinical Trial

Official title:
Follow-up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 1 to 6 Years

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00161850
Other study ID # 206
Secondary ID
Status Completed
Phase Phase 2
First received September 8, 2005
Last updated May 20, 2015
Start date February 2002
Est. completion date August 2002

Study information
Verified date May 2015
Source Pfizer
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 investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).

Recruitment information / eligibility
Status Completed
Enrollment 615
Est. completion date August 2002
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 6 Years
Eligibility Inclusion Criteria:

All volunteers who participated in Baxter study 199 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:

- They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 199

- Written informed consent from the legal guardian is available.

Exclusion Criteria:

There are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.

Volunteers will be excluded from vaccination and consecutive visits in this study if they:

- Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)

- Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 199

- Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199

- Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions

- Have received banked human blood or immunoglobulins within one month of study entry

- Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 199

- Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 199

- Had received an investigational new drug within 6 weeks prior to study start

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Austria Grieskirchner Strasse 17 Wels
Germany Neuschwanstein Strasse 5 Augsburg
Germany Marktplatz 33 Bad Saulgau
Germany Hauptstrasse 9 Bietigheim-Bissingen
Germany Salzgasse 11 Calw
Germany Mohrenstrasse 8 Coburg
Germany Bahnhofstrasse 1 Elzach
Germany Rheinstrasse 1a Ettenheim
Germany Ehlerstrasse 17 Friedrichshafen
Germany Peter-Seifert Strasse 5 Gersfeld
Germany Solothumer Strasse 2 Heilbronn
Germany Hauptstrasse 240 Kehl
Germany Schwarzwald Strasse 20 Kirchzarten
Germany Altoettinger Strasse 3 Landsberg
Germany Rastatter Strasse 7 Mannheim-Secken
Germany Wilhelmstrasse 25 Metzingen
Germany Dohmbuehler Strasse 8 Nuernberg
Germany Glogauer Strasse 15 Nuernberg
Germany Tuchbergstrasse 2 Oberndorf/Neckar
Germany Asternweg 11a Offenburg
Germany Wilhelmstrasse 7 Offenburg
Germany Bergstrasse 27 Rottweil
Germany Berneckstrasse 19 Schramberg
Germany Hauptstrasse 11 Tegernsee
Germany Broner Platz 6 Weingarten

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Austria,  Germany, 

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 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 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 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