Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

302 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-06

Study Completion Date

2010-05-20

Brief Summary

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The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with FSME-IMMUN 0.25 ml Junior only, administered according to the conventional schedule (0, 28 and 360 days).

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Detailed Description

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Conditions

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Encephalitis, Tick-Borne

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.

Group Type EXPERIMENTAL

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Intervention Type BIOLOGICAL

Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360

2

Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.

Group Type EXPERIMENTAL

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Intervention Type BIOLOGICAL

Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.

Interventions

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Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360

Intervention Type BIOLOGICAL

Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Male and female children will be eligible for participation in this study if:

* they are aged \>= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening;
* their parents / legal guardians provide written informed consent;
* children provide written assent to the study according to age and capacity of understanding;
* their parents/guardians understand the nature of the clinical study and will comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits);
* they are generally healthy, (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study);
* provide a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children).

Exclusion Criteria

Subjects will be excluded from participation if:

* they have a history of any previous TBE vaccination;
* they have a history of TBE infection;
* they have a history of infection with other flaviviruses;
* they have a history of vaccination against yellow fever and/or Japanese B encephalitis;
* they have a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines;
* they are suffering from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
* they have received any blood product or immunoglobulins within 90 days prior to study entry;
* they are known to be Human Immunodeficiency Virus (HIV) positive (an HIV test is not required specifically for the purpose of this study);
* they have a functional or surgical asplenia;
* they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation;
* they were administered an investigational product within six weeks prior to study start or are concurrently participating in another clinical study that includes the administration of an investigational product;
* they are pregnant or breastfeeding (if a female subject);
* they or their parents/legal guardian(s) are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study.
* Subjects who have an acute illness with or without elevated body temperature (\>=37.5°C) within 3 days prior to the scheduled first vaccination will not be vaccinated. Subjects may be included at a repeat visit provided that (1) the illness has resolved (body temperature \< 37.5 °C), (2) the repeat visit is no more than 14 calendar days after the Screening Visit, and (3) the center is still open for recruitment.
* If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later date, as long as the center is still open for recruitment.
* Subjects who received any live vaccine within 4 weeks or any inactivated vaccine within 2 weeks prior to the scheduled first study vaccination will not be vaccinated until an interval of 4 or 2 weeks, respectively, has passed, provided the center is still open for recruitment.
* If a subject was bitten by a tick within 4 weeks prior to the scheduled first or second vaccination, the vaccination must be postponed until an interval of 4 weeks has passed.

Minimum Eligible Age

1 Year

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes