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Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

Primary Purpose

Tick-borne Encephalitis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
FSME-IMMUN NEW 0.25 ml
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tick-borne Encephalitis

Eligibility Criteria

1 Year - 15 Years (Child)All Sexes

Inclusion Criteria: Male and female children and adolescents will be eligible for participation in this study if: they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday); they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial); their parents/legal guardians understand the nature of the study and agree to its provisions; written informed consent is available from both parents/legal guardians, for Germany/Austria: additional written informed consent is available for children older than 8 years they or their parents/legal guardians agree to keep a volunteer diary. For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria: - negative pregnancy test at study entry; Exclusion Criteria: Children and adolescents will be excluded from participation in this study if they: have a history of any TBE vaccination; have a history of TBE infection; have a history of allergic reactions to one of the components of the vaccine; 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; are known to be HIV positive (a special HIV test is not required for the purpose of the study); have received banked blood or immunoglobulins within one month of study entry; have a history of vaccination against yellow fever and/or Japanese B-encephalitis; suffer from hemorrhagic diathesis; are participating simultaneously in another clinical trial; if female: are pregnant or breastfeeding. Volunteers who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature > 38°C) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal. Volunteers who have received any other vaccination within 4 weeks prior to visit 1 will not be vaccinated until an interval of 4 weeks has passed. In this case visit 1 will take place separately. If volunteers have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time. Volunteers who have a positive TBE antibody value prior to the first vaccination will be excluded from the statistical analysis of the primary endpoint.

Sites / Locations

  • Grieskirchner Strasse 17
  • Marktplatz 3
  • Solothurner Strasse 2
  • Hauptstraße 240
  • Wojewodzki Szpital Dziececy oddz. Obserwacyjno-Zakazny
  • Szpital Jana Pawla II Odz. Neuroinfekcji
  • Samodzielny Publiczny ZOZ Oddzial Dzieciecy
  • PANTAMED sp.z.o.o.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
May 20, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00161863
Brief Title
Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
Official Title
Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to investigate the safety of five consecutive lots of FSME-IMMUN NEW in healthy volunteers. The main criterion for investigation is the fever rate after the first vaccination in three different age classes. The immunogenicity of 0.25 ml FSME-IMMUN NEW has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tick-borne Encephalitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
FSME-IMMUN NEW 0.25 ml

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Eligibility Criteria
Inclusion Criteria: Male and female children and adolescents will be eligible for participation in this study if: they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday); they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial); their parents/legal guardians understand the nature of the study and agree to its provisions; written informed consent is available from both parents/legal guardians, for Germany/Austria: additional written informed consent is available for children older than 8 years they or their parents/legal guardians agree to keep a volunteer diary. For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria: - negative pregnancy test at study entry; Exclusion Criteria: Children and adolescents will be excluded from participation in this study if they: have a history of any TBE vaccination; have a history of TBE infection; have a history of allergic reactions to one of the components of the vaccine; 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; are known to be HIV positive (a special HIV test is not required for the purpose of the study); have received banked blood or immunoglobulins within one month of study entry; have a history of vaccination against yellow fever and/or Japanese B-encephalitis; suffer from hemorrhagic diathesis; are participating simultaneously in another clinical trial; if female: are pregnant or breastfeeding. Volunteers who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature > 38°C) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal. Volunteers who have received any other vaccination within 4 weeks prior to visit 1 will not be vaccinated until an interval of 4 weeks has passed. In this case visit 1 will take place separately. If volunteers have received antipyretics within 4 hours prior to the intended TBE vaccination, the vaccination should be performed at a later time. Volunteers who have a positive TBE antibody value prior to the first vaccination will be excluded from the statistical analysis of the primary endpoint.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baxter BioScience Investigator
Organizational Affiliation
Baxter BioScience
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grieskirchner Strasse 17
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Marktplatz 3
City
Bad Saulgau
ZIP/Postal Code
88348
Country
Germany
Facility Name
Solothurner Strasse 2
City
Heilbronn
ZIP/Postal Code
74072
Country
Germany
Facility Name
Hauptstraße 240
City
Kehl
ZIP/Postal Code
77694
Country
Germany
Facility Name
Wojewodzki Szpital Dziececy oddz. Obserwacyjno-Zakazny
City
Kielce
ZIP/Postal Code
25381
Country
Poland
Facility Name
Szpital Jana Pawla II Odz. Neuroinfekcji
City
Krakow
ZIP/Postal Code
31202
Country
Poland
Facility Name
Samodzielny Publiczny ZOZ Oddzial Dzieciecy
City
Lubartow
ZIP/Postal Code
21100
Country
Poland
Facility Name
PANTAMED sp.z.o.o.
City
Olsztyn
ZIP/Postal Code
10-461
Country
Poland

12. IPD Sharing Statement

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Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

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