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New Study - Humoral Response to Tick-borne Encephalitis Vaccine in Elderly

NCT02318069 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2021-02-10

No results posted yet for this study

Summary

The risk for tick borne encephalitis increases in Sweden. Together with an increased awareness of the possibility to acquire protection by vaccination, this has led to an increase in the number of doses of the vaccine distributed in Sweden each year - now being approximately 400.000. The first year, two doses with an interval of 1 month is recommended for the general population, followed by a third dose approximately one year later and an additional booster dose three years after the third.

Preliminary results from a previous study showed a higher percentage protected (=titer at least 10) after 3 doses than after 2 doses (Rombo et al. EUDRA CT 2011 001348-31, unpublished information). In the same study, there were no differences between those who were vaccinated 0+7+21 compared to 0+30+90. The investigators were surprised to find marked differences between 2 and 3 doses also in the younger control group.

The investigators therefore aim to confirm results in a new study and to add a group with a double dose at day 0 and then a single dose at day 30 and 360

Conditions

  • Tick-borne Encephalitis

Interventions

BIOLOGICAL

FSME-immune

0.5 ml im as scheduled in the 5 arms

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Helsingfors university

    collaborator UNKNOWN

  • Sormland County Council, Sweden

    lead OTHER

Principal Investigators

  • lars rombo, MD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-02-29
Completion
2017-06-30

Countries

  • Finland
  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02318069 on ClinicalTrials.gov