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

May 20, 2015 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wels, Austria, 4600
        • Grieskirchner Strasse 17
  • Germany
      • Bad Saulgau, Germany, 88348
        • Marktplatz 3
      • Heilbronn, Germany, 74072
        • Solothurner Strasse 2
      • Kehl, Germany, 77694
        • Hauptstrasse 240
  • Poland
      • Kielce, Poland, 25381
        • Wojewodzki Szpital Dziececy oddz. Obserwacyjno-Zakazny
      • Krakow, Poland, 31202
        • Szpital Jana Pawla II Odz. Neuroinfekcji
      • Lubartow, Poland, 21100
        • Samodzielny Publiczny ZOZ Oddzial Dzieciecy
      • Olsztyn, Poland, 10-461
        • PANTAMED sp.z.o.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 15 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion

January 1, 2003

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 209

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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