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

Phase 3

Completed

• Conditions: Tick-borne Encephalitis

• Registration Number: NCT00161863
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study Completion: 2003-01
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-13
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (8)

Szpital Jana Pawla II Odz. Neuroinfekcji; 🇵🇱 Krakow, Poland

Solothurner Strasse 2; 🇩🇪 Heilbronn, Germany

PANTAMED sp.z.o.o.; 🇵🇱 Olsztyn, Poland

Marktplatz 3; 🇩🇪 Bad Saulgau, Germany

Wojewodzki Szpital Dziececy oddz. Obserwacyjno-Zakazny; 🇵🇱 Kielce, Poland

Hauptstraße 240; 🇩🇪 Kehl, Germany

Samodzielny Publiczny ZOZ Oddzial Dzieciecy; 🇵🇱 Lubartow, Poland

Grieskirchner Strasse 17; 🇦🇹 Wels, Austria