Encephalitis, Tick-bornePhase 3NCT00161824
Safety Study in Volunteers From 16 to 65 Years of Age: FSME IMMUN NEW vs. ENCEPUR
A Phase 3 study testing Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in people with Encephalitis, Tick-borne, run by Pfizer at 7 sites in Poland.
Trial summary
The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy… Read more about this study
- Who is it for?
- Ages 16 to 65 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
- 3,800 participants
- Where
- 7 sitesPoland
- Study dates
- Oct 2001to Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and female volunteers were eligible for participation in this study if they:
- Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th birthday) old
- Were clinically healthy
- Had a negative pregnancy test at the first medical examination, if female and capable of bearing children
- Agreed to employ adequate birth control measures for the duration of the study, if female and capable of bearing children
- Provided written informed consent
- For volunteers under 18 years of age - written informed consent of the parents / guardian was available
- Agreed to keep a volunteer diary
Who cannot join
- History of any previous TBE vaccination
- History of TBE infection or show evidence of latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml)
- History of allergic reactions, in particular to one of the components of the vaccine
- Previously received volume substitution with a product containing polygeline (stabilizer in ENCEPUR)
- Received antipyretics within 4 hours prior to the first TBE vaccination
- Suffer from a disease that cannot be effectively treated or stabilized
Show all 17Show fewer
- Suffering from a disease (e.g. autoimmune disease) or were undergoing any form of treatment that could be expected to influence immunological functions
- Suffering from chronic, degenerative and/or inflammatory disease of the central nervous system
- Using any immunosuppressive drugs (e.g. local or systemic corticosteroids, chemotherapeutics)
- Had a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages)
- Had donated blood or plasma within one month of the study start
- Had received banked blood or immunoglobulins within one month of study entry
- Known to be HIV positive (a special HIV test was not required for the purpose of the study)
- Suffering from a febrile illness at study entry
- History of vaccination against yellow fever and / or Japanese B encephalitis
- Participating simultaneously in another clinical trial
- If female: pregnant or breast feeding
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Poland7 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
About this study
Official title: Single-blind, Randomized, Multicenter Comparison of FSME IMMUN NEW and ENCEPUR: Safety and Tolerability of Two Vaccinations in Healthy Volunteers Aged 16 to 65 Years.
The purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.
- Conditions
- Encephalitis, Tick-borne
- Being tested
- Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
- 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 startOct 2001
- Study completionJan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 3,800 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 PediatrycznyKrystnyna 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, MD, Principal investigator, Szpital Jana Pawla II Oddzial Neuoinfekcji
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161824
- Sponsor's protocol ID
- 208
- 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
- Single-blind, Randomized, Multicenter Comparison of FSME IMMUN NEW and ENCEPUR: Safety and Tolerability of Two Vaccinations in Healthy Volunteers Aged 16 to 65 Years.
- ClinicalTrials.gov ID
- NCT00161824
- Acronym / sponsor ID
- 208
- Conditions
- Encephalitis, Tick-borne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,800 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- Jan 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 purpose of this study is to assess the safety of a vaccination schedule consisting of two vaccinations (21-35 days apart) with the tick-borne encephalitis (TBE) vaccine FSME-IMMUN NEW (5 consecutive lots) in comparison to another licensed TBE vaccine (Encepur® adults, with polygeline) (2 lots) in healthy volunteers aged 16 to 65 years.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th birthday) old
- Were clinically healthy
- Had a negative pregnancy test at the first medical examination, if female and capable of bearing children
- Agreed to employ adequate birth control measures for the duration of the study, if female and capable of bearing children
- Provided written informed consent
Key exclusion criteria (17 listed)
- History of any previous TBE vaccination
- History of TBE infection or show evidence of latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml)
- History of allergic reactions, in particular to one of the components of the vaccine
- Previously received volume substitution with a product containing polygeline (stabilizer in ENCEPUR)
- Received antipyretics within 4 hours prior to the first TBE vaccination
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
7 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 7 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 8 inclusion and 17 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 7 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.