Encephalitis, Tick-bornePhase 3NCT00161876
FSME IMMUN NEW Follow-up to Study 208 in Volunteers Aged 16 to 66 Years
A Phase 3 study testing Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in people with Encephalitis, Tick-borne, run by Pfizer at 8 sites in Poland.
Trial summary
The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME IMMUN NEW and ENCEPUR in healthy volunteers aged 16 to 65 years). Read more about this study
- Who is it for?
- Ages 16 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- Encephalitis, Tick-borne
- What is being tested?
- Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
- Type of treatment
- Vaccines
- How many people
- 3,973 participants
- Where
- 8 sitesPoland
- Study dates
- May 2002to Aug 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 66 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Received two vaccinations during the course of Baxter study 208
- Understand the nature of the study, agree to its provisions and give written informed consent
- For volunteers under 18 years of age - written informed consent of the parents/legal guardian is given
Who cannot join
- None.
- Volunteers assessed for eligibility to receive a third vaccination.
- Eligibility to receive third vaccination:
- ELISA value > 126 VIE U/ml before the first TBE vaccination in Baxter study 208
- Not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial)
- Have already been administered a third TBE vaccination elsewhere since receiving the two vaccinations in Baxter study 208
Show all 15Show fewer
- Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 208
- Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
- Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent dose of other alcoholic beverages)
- Have received banked human blood or immunoglobulins within one month of study entry
- Are known to have become infected with HIV (a special HIV test is not required for the purpose of the study) since the last visit of study 208
- Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in study 208
- Have received an investigational new drug within 6 weeks prior to study start
- Have a positive pregnancy test at the first medical examination (for females capable of bearing children)
- Do not agree to employ adequate birth control measures for the duration of the study (for females capable of bearing children)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Poland8 sites
Zespol Opieki Zdrowotnej w Debicy
Dębica, 33-200
Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny A
Kielce, 25-381
"Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu Oddechowego
Krakow, 30-018
Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"
Krakow, 30-969
Szpital Jana Pawla II Oddzial Neuroinfekcji
Krakow, 31-202
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
Lubartów, 21-100
PANTAMED sp. z o.o.
Olsztyn, 10-461
Oddzial Chorób Zakaznych Specjalistyczny Szpital im. E. Szczeklika
Tarnów, 33-100
About this study
Official title: Open-label, Multicenter, Follow-up Phase III Study to Investigate the Safety of the Third Vaccination of FSME-IMMUN NEW in Volunteers Aged 16 to 66 Years
The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME IMMUN NEW and ENCEPUR in healthy volunteers aged 16 to 65 years).
- Conditions
- Encephalitis, Tick-borne
- Being tested
- Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
- Keywords
- tick-borne encephalitis
- Medical subject headings
- Encephalitis, Tick-Borne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startMay 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Encephalitis, Tick-borneStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,973 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jerzy Romaszko, MD, Principal investigator, PANTAMED sp. z o o.Jerzy Brzostek, MD, Principal investigator, Zespol Opieki Zdrowotnej w DebicyJerzy Dziduch, MD, Principal investigator, Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial PediatrycznyKrystyna Jurowska, MD, Principal investigator, Przedsiebiorstwo Uslug Medycznych "Centrum Medyczne Nowa Huta"Marian Patrzalek, MD, Principal investigator, Wojewodzki Szpital Dzieciecy Oddzial Obserwacyjno - Zakazny AKrzysztof Sladek, MD, Principal investigator, "Atopia" Diagnostyka i Leczenie Chorob Alergicznych i Ukladu OddechowegoRyszard Konior, Principal investigator, Szpital Jana Pawla II Oddzial NeuoinfekcjiGrazyna Zawada-Skrobisz, MD, Principal investigator, Oddzial Chorob Zakaznych Specjalistyczny Szpital, Tarnow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161876
- Sponsor's protocol ID
- 213
- Status last verified
- May 2015
- First submitted
- 8 Sep 2005
- Last updated
- 21 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Follow-up Phase III Study to Investigate the Safety of the Third Vaccination of FSME-IMMUN NEW in Volunteers Aged 16 to 66 Years
- ClinicalTrials.gov ID
- NCT00161876
- Acronym / sponsor ID
- 213
- Conditions
- Encephalitis, Tick-borne
- Keywords
- tick-borne encephalitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,973 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Study completion
- Aug 2002
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the safety of the third vaccination with FSME-IMMUN NEW in all volunteers who received both vaccinations in Baxter study 208 (safety study of FSME IMMUN NEW and ENCEPUR in healthy volunteers aged 16 to 65 years).
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Received two vaccinations during the course of Baxter study 208
- Understand the nature of the study, agree to its provisions and give written informed consent
- For volunteers under 18 years of age - written informed consent of the parents/legal guardian is given
Key exclusion criteria (15 listed)
- None.
- Volunteers assessed for eligibility to receive a third vaccination.
- ELISA value > 126 VIE U/ml before the first TBE vaccination in Baxter study 208
- Not clinically healthy, (i.e. the physician would have reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial)
- Have already been administered a third TBE vaccination elsewhere since receiving the two vaccinations in Baxter study 208
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerzy Romaszko, MD principal investigator
PANTAMED sp. z o o.
Jerzy Brzostek, MD principal investigator
Zespol Opieki Zdrowotnej w Debicy
Jerzy Dziduch, MD principal investigator
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Oddzial Pediatryczny
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in people with Encephalitis, Tick-borne, run by Pfizer at 8 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.