Dose-finding Study to Investigate the Safety and Immunogenicity of Two Vaccinations With FSME IMMUN NEW in Healthy Volunteers Aged 6 to 16 Years.

• ClinicalTrials.gov Identifier: NCT00161798
• Recruitment Status: Completed
• First Posted: September 13, 2005
• Last Update Posted: May 21, 2015
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: September 8, 2005
• First Posted Date: September 13, 2005
• Last Update Posted Date: May 21, 2015
• Study Start Date: September 2001
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Prevention
• Condition: Tick-borne Encephalitis
• Intervention: Biological: Tick-borne encephalitis vaccine
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Study Completion Date: March 2002
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 15 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00161798
• Other Study ID Numbers: 205
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ulrich Behre, MD; Hauptstrasse 240, 77694 Kehl, Germany

• PRS Account: Pfizer
• Verification Date: May 2015