ClinicalTrials.gg
CompletedNCT00163618Updated May 21, 2015

Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children

An observational study in Encephalitis, Tick-borne, sponsored by Pfizer. Completed at 4 sites in Austria. Open to participants aged 7 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-21.

Sponsored by Pfizer · Observational

Study type
Observational
Ages
7 Years to 11 Years
Sex
All
01

Study summary

The objective of this study is to assess the TBE antibody persistence approximately three years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.

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
7 Years to 11 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

  • Male and female children who participated in Study 146A if:
  • they and/or their parents/legal guardians understand the nature of the study and agree to its provisions
  • written is available from the child (according to age and capacity of understanding) and the parents/legal guardians
  • they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A
  • they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A

Exclusion criteria

Exclusion Criteria:

  • Subjects who received any further TBE vaccination since their first TBE booster vaccination
  • Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A
  • Subjects who have suffered from a disease (e.g. disease) or have undergone a form of treatment (e.g. systemic ) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination
  • Subjects who have been known to be positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A
  • Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry
Terms in these criteria, in plain language(4)

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

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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.

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.

05

Study design

Interventions

  • BiologicalFormaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
06

Study locations

4 sites
  • Bahnhofstraße 9
    Hermagor, 9620, Austria
  • Freistädter Strasse 290
    Linz, 4040, Austria
  • Conrad-von-Hoetzendorf-Strasse
    Voitsberg, 8570, Austria
  • Grieskirchner Strasse 17
    Wels, 4600, Austria
07

Updates

Tracking since Sep 25, 2026
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 ↗
08

Registry details

Key details

Study ID
NCT00163618
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 14, 2005
Start date
Jun 2005
Completion
Jul 2006
Last update
May 21, 2015

Study contacts

Baxter BioScience Investigator
principal investigator · Baxter Healthcare Corporation

Oversight

Data monitoring committee
No
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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