Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.
NCT00161798
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 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday);
- they are clinically healthy;
- their legal representative - and if older than 8 years the volunteer - understands the nature of the study, agrees to its provisions and gives written informed consent;
- their legal representative agrees to keep a Volunteer Diary.
For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start:
- negative pregnancy test at study start;
- they agree to employ adequate birth control measures for the duration of the study.
Children will be excluded from participation in this study if they:
- have a history of any previous TBE vaccination;
- have a history of TBE infection or show evidence of a latent TBE infection (as
demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10);
- have a history of allergic reactions, in particular to one of the components of the
vaccine;
- have received antipyretics within 4 hours prior to the first TBE vaccination;
- suffer from a disease that cannot be effectively treated or stabilized;
- suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment
that can be expected to influence immunological functions;
- suffer from chronic, degenerative and / or inflammatory disease of the central nervous
system;
- are known to be HIV positive (a special HIV test is not required for the purpose of
the study);
- suffer from a febrile illness at study entry;
- have a history of vaccination against yellow fever and / or Japanese B-encephalitis;
- are participating simultaneously in another clinical trial.
- if female, are pregnant or breast feeding
Volunteers who meet the inclusion / exclusion criteria, but have a febrile illness (body
temperature >= 38° C, measured orally) at the scheduled time of vaccination, will not be
vaccinated before their body temperature returns to normal.
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Descriptive Information | ||||
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Brief Title ICMJE | Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years. | |||
Official Title ICMJE | Double-blind, Randomized, Multicenter Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years. | |||
Brief Summary | The purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a TBE vaccine will be investigated in healthy children aged 6 to 16 years. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention | |||
Condition ICMJE | Tick-borne Encephalitis | |||
Intervention ICMJE | Biological: Tick-borne encephalitis vaccine | |||
Study Arms ICMJE | Not Provided | |||
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 | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | March 2002 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Male and female children will be eligible for participation in this study if:
For safety reasons female volunteers capable of bearing children have to fulfill the following inclusion criteria at study start:
Exclusion Criteria: Children will be excluded from participation in this study if they:
Volunteers who meet the inclusion / exclusion criteria, but have a febrile illness (body temperature >= 38° C, measured orally) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal. | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 6 Years to 15 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Germany | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00161798 | |||
Other Study ID Numbers ICMJE | 205 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
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 |