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CompletedNCT00161954Updated May 21, 2015

Immunogenicity and Safety Study of a Rapid Immunization Schedule With FSME-IMMUN 0.5 mL in Healthy Adults Aged 16 - 65 Years

A Phase 4 interventional study of Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in Encephalitis, Tick-borne, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-21.

Sponsored by Pfizer · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Allocation
Non-randomized
Ages
16 Years to 65 Years
Sex
All
01

Study summary

The objective of this study is to establish the earliest time point at which vaccines are expected to show seropositive antibody levels after vaccination with FSME-IMMUN 0.5 mL using a rapid immunization schedule (2 vaccinations administered 12 +/- 2 days apart.

02

Conditions studied

  • Encephalitis, Tick-borne

Keywords

  • Tick-Borne Encephalitis
03

In context

Encephalitis, Tick-Borne

51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.

Browse Encephalitis, Tick-Borne studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Understanding the nature of the study, agreement to its provisions and written
  • Written informed consent of subject´s parents / legal guardians (if subject is under 18 years of age)
  • Aged >= 16 years (from the 16th birthday) to \<= 65 years (to the last day before the 66th birthday)
  • Clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial)
  • Negative pregnancy test result at the first medical examination (if female and capable of bearing children)
  • Agreeing to employ adequate measures for the duration of the study (if female and capable of bearing children)
  • Agreeing to keep a subject diary.

Exclusion criteria

Exclusion Criteria:

  • History of any previous TBE vaccination
  • History of TBE infection
  • History of infection with other flaviviruses
  • History of vaccination against yellow fever and/or Japanese B-encephalitis
  • History of allergic reactions, in particular to one of the components of the vaccine
  • Suffering from a disease (e.g. disease) or undergoing a form of treatment (e.g. systemic ) that can be expected to influence immunological functions
  • Known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
  • Donation of blood or plasma within one month of study start
  • Having received a blood transfusion or immunoglobulins within one month of study entry
  • positivity (an HIV test is not required specifically for the purpose of this study
  • Simultaneous participation in another clinical trial including administration of an product
  • Participating in any other clinical study within six weeks prior to study start
  • Participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies)
  • Pregnancy or lactation (if female)
  • Having received any other vaccination within two weeks prior to study entry
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
06

Study locations

1 site
  • SGS Biopharma Research Unit Stuivenberg
    Antwerp, 2060, Belgium
07

References and documents

Publications

  • Orlinger KK, Hofmeister Y, Fritz R, Holzer GW, Falkner FG, Unger B, Loew-Baselli A, Poellabauer EM, Ehrlich HJ, Barrett PN, Kreil TR. A tick-borne encephalitis virus vaccine based on the European prototype strain induces broadly reactive cross-neutralizing antibodies in humans. J Infect Dis. 2011 Jun 1;203(11):1556-64. doi: 10.1093/infdis/jir122. PubMed 21592984 ↗
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2004 and a completion of May 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2005
First posted
Sep 13, 2005
Start
Mar 2004
Completion
May 2004
Last update
May 21, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on May 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00161954
Lead sponsor
Pfizer
First posted
Sep 13, 2005
Start date
Mar 2004
Completion
May 2004
Last update
May 21, 2015

Study contacts

Baxter BioScience Investigator
principal investigator · Baxter BioScience
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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