Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children
NCT00840801
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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).
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.
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Descriptive Information | ||||
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Brief Title ICMJE | Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children | |||
Official Title ICMJE | Single-blind, Randomized, Phase 3B Study in Children Aged 1 - 11 Years to Investigate the Immunogenicity, Safety and Interchangeability of Two Tick-borne Encephalitis (Tbe) Vaccines Administered According to a Conventional Schedule | |||
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-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). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Prevention | |||
Condition ICMJE | Encephalitis, Tick-Borne | |||
Intervention ICMJE |
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Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 302 | |||
Original Estimated Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | August 2010 | |||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Male and female children will be eligible for participation in this study if:
Exclusion Criteria: Subjects will be excluded from participation if:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 1 Year to 11 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Czech Republic | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00840801 | |||
Other Study ID Numbers ICMJE | 700801 EUDRACT NUMBER: 2008-002691-10 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |