Status:
COMPLETED
Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
Lead Sponsor:
Pfizer
Conditions:
Encephalitis, Tick-Borne
Eligibility:
All Genders
1-11 years
Phase:
PHASE3
Brief Summary
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 6 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2010
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT00840801
Start Date
February 6 2009
End Date
May 20 2010
Last Update
January 19 2024
Active Locations (8)
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1
Unterer Graben 2
Eferding, Upper Austria, Austria, 4070
2
Grieskirchnerstr.17
Wels, Upper Austria, Austria, 4600
3
Private surgery of General Practitioner for children and juveniles
Havlíčkův Brod, Czechia, 580 01
4
University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581
Hradec Králové, Czechia, 50005