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

Pfizer

Status and phase

Completed

Phase 3

Conditions

Tick-borne Encephalitis

Treatments

Biological: FSME-IMMUN NEW 0.25 ml

Study type

Interventional

Funder types

Industry

Identifiers

NCT00161863

209

Details and patient eligibility

About

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.

Sex

All

Ages

1 to 15 years old

Volunteers

No Healthy Volunteers

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.