Clinical trial NCT00161863: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tick-borne Encephalitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wels
country: Austria
facility: Grieskirchner Strasse 17
city: Bad Saulgau
country: Germany
facility: Marktplatz 3
city: Heilbronn
country: Germany
facility: Solothurner Strasse 2
city: Kehl
country: Germany
facility: Hauptstraße 240
city: Kielce
country: Poland
facility: Wojewodzki Szpital Dziececy oddz. Obserwacyjno-Zakazny
city: Krakow
country: Poland
facility: Szpital Jana Pawla II Odz. Neuroinfekcji
city: Lubartow
country: Poland
facility: Samodzielny Publiczny ZOZ Oddzial Dzieciecy
city: Olsztyn
country: Poland
facility: PANTAMED sp.z.o.o.
Study officials:
affiliation: Baxter BioScience
name: Baxter BioScience Investigator
role: PRINCIPAL_INVESTIGATOR
References: