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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

About this trial

This is an interventional prevention trial for Encephalitis, Tick-borne focused on measuring Tick-Borne Encephalitis

Eligibility Criteria

6 Months - 47 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Wiener Strasse 50/2
Erzherzog Johann Strasse 9
Fronleichnamsweg 10
Hauptstrasse 61
Brauhausgasse 1
Conrad-von-Hötzendorf Strasse
Grieskirchner Strasse 17

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00161746

First Posted

September 8, 2005

Last Updated

May 20, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00161746

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

April 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 1999 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Encephalitis, Tick-borne

Keywords

Tick-Borne Encephalitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

47 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baxter BioScience Investigator

Organizational Affiliation

Baxter Healthcare Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wiener Strasse 50/2

City

Kapfenberg

ZIP/Postal Code

8605

Country

Austria

Facility Name

Erzherzog Johann Strasse 9

City

Leoben

ZIP/Postal Code

8700

Country

Austria

Facility Name

Fronleichnamsweg 10

City

Liezen

ZIP/Postal Code

8940

Country

Austria

Facility Name

Hauptstrasse 61

City

Linz

ZIP/Postal Code

4040

Country

Austria

Facility Name

Brauhausgasse 1

City

Mürzzuschlag

ZIP/Postal Code

8680

Country

Austria

Facility Name

Conrad-von-Hötzendorf Strasse

City

Voitsberg

ZIP/Postal Code

8570

Country

Austria

Facility Name

Grieskirchner Strasse 17

City

Wels

ZIP/Postal Code

4600

Country

Austria

Encephalitis, Tick-borne

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial