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

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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

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.
    


Study Phase

Phase 3

Study Type

Interventional




Condition

Tick-borne Encephalitis

Intervention

FSME-IMMUN NEW 0.25 ml


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological


Start Date

September 2002

Completion Date

January 2003


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.
      

Gender

All

Ages

1 Year - 15 Years


Contacts

Baxter BioScience Investigator, , 

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT00161863

Organization ID

209



Study Sponsor

Pfizer


Study Sponsor

Baxter BioScience Investigator, Principal Investigator, Baxter BioScience


Verification Date

May 2015