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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Grieskirchner Strasse 17
Wels, , 4600 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tick-borne Encephalitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-15 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00161863
Pfizer
Completed
Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years

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Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
Open-label Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Tick-borne Encephalitis
Biological: FSME-IMMUN NEW 0.25 ml
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
January 2003
Not Provided

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.

Sexes Eligible for Study: All
1 Year to 15 Years   (Child)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   Poland
 
 
NCT00161863
209
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Principal Investigator: Baxter BioScience Investigator Baxter BioScience
Pfizer
May 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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