Status:
COMPLETED
Safety Study of FSME-IMMUN NEW in Healthy Children and Adolescents Aged 1 to 15 Years
Lead Sponsor:
Pfizer
Conditions:
Tick-borne Encephalitis
Eligibility:
All Genders
1-15 years
Phase:
PHASE3
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 vaccinat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2003
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00161863
Start Date
September 1 2002
End Date
January 1 2003
Last Update
May 21 2015
Active Locations (8)
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1
Grieskirchner Strasse 17
Wels, Austria, 4600
2
Marktplatz 3
Bad Saulgau, Germany, 88348
3
Solothurner Strasse 2
Heilbronn, Germany, 74072
4
Hauptstraße 240
Kehl, Germany, 77694