Open-Label Phase 3b Clinical Study to Evaluate the Immunogenicity and Safety of FSME-IMMUN 0.5 ml With the First and Second Vaccination Being Administered According to a Rapid Immunization Schedule in Healthy Adults Aged 16 Years or Older
Sponsor study identifier
interventional
330
1 country
4
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2007
Actual (reported)Study Completion
Not reported
Date not reportedThe objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: \> 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
April 13, 2007
Actual (reported)April 16, 2007
Actual (reported)November 2007
Actual (reported)Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centrum Badan Farmakologii Klinicznej monipol
Krakow, 30-969, Poland
Niepubliczny ZOZ "Atarax" s.c.
Olsztyn, 10-117, Poland
Niepubliczny ZOZ "VITA"
Olsztyn, 10-295, Poland
"PANTAMED" Sp. z o.o.
Olsztyn, 10-461, Poland
Baxter BioScience Investigator, MD
Baxter BioScience
First Submitted
April 13, 2007
First Posted
April 16, 2007
Study Start
September 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2007
Actual (reported)Contact the study team to confirm eligibility.
Last Updated
April 19, 2023
Record last verified: 2023-04
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Source: ClinicalTrials.gov.
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