Encephalitis, Tick-BornePhase 3NCT00460486
Immunogenicity and Safety Study of FSME-IMMUN 0.5 mL in Adult Subjects Previously Vaccinated According to a Rapid Immunization Schedule
A Phase 3 study testing Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl in people with Encephalitis, Tick-Borne, run by Pfizer at 4 sites in Poland.
Trial summary
The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Encephalitis, Tick-Borne
- What is being tested?
- Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
- How many people
- 330 participants
- Where
- 4 sitesPoland
- Study dates
- Sep 2006to Nov 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects will be eligible for participation in this study if they:
- Understand the nature of the study, agree to its provisions and provide written informed consent (assent if the subjects is under 18 years of age);
- Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age);
- Are aged >= 16 years (from the 16th birthday) at screening;
- Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial);
- Have a negative pregnancy test result at the first medical examination (if female and capable of bearing children);
- Agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children);
- Agree to keep a Subject Diary.
Who cannot join
- Subjects will be excluded from participation in this study if they:
- Have a history of any previous tick-borne encephalitis (TBE) vaccination;
- Have a history of TBE infection;
- Have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis);
- Have a history of allergic reactions, in particular to one of the components of the vaccine;
- Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
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- Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages);
- Have donated blood or plasma within 30 days of study entry;
- Have received a blood transfusion or immunoglobulins within 30 days of study entry;
- Are known to be HIV positive (an HIV test is not required specifically for the purpose of this study);
- Are simultaneously participating in another clinical trial including administration of an investigational product;
- Have participated in any other clinical study within six weeks prior to study entry;
- Are pregnant or breastfeeding (if female);
- Are a member of the team conducting this study or are in a dependent relationship with the study investigator. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator.
- Have received any other vaccination within two weeks prior to study entry.
Trial locations and contacts
4 sites in 1 country.
Poland4 sites
Centrum Badan Farmakologii Klinicznej monipol
Krakow, 30-969
Niepubliczny ZOZ "Atarax" s.c.
Olsztyn, 10-117
Niepubliczny ZOZ "VITA"
Olsztyn, 10-295
"PANTAMED" Sp. z o.o.
Olsztyn, 10-461
About this study
Official title: Open-Label Phase 3b Clinical Study to Evaluate the Immunogenicity and Safety of FSME-IMMUN 0.5 ml With the First and Second Vaccination Being Administered According to a Rapid Immunization Schedule in Healthy Adults Aged 16 Years or Older
The objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.
- Conditions
- Encephalitis, Tick-Borne
- Being tested
- Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
- 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.
Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain NeudörflBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startSep 2006
- Primary completionNov 2007
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Baxter BioScience Investigator, MD, Principal investigator, Baxter BioScience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460486
- Sponsor's protocol ID
- 690601
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2007
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Phase 3b Clinical Study to Evaluate the Immunogenicity and Safety of FSME-IMMUN 0.5 ml With the First and Second Vaccination Being Administered According to a Rapid Immunization Schedule in Healthy Adults Aged 16 Years or Older
- ClinicalTrials.gov ID
- NCT00460486
- Acronym / sponsor ID
- 690601
- Conditions
- Encephalitis, Tick-Borne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Nov 2007 (actual)
- First posted
- 16 Apr 2007 (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 objective of this study is to investigate the immunogenicity and safety of FSME-IMMUN 0.5 ml in two age strata (stratum A: 16 to 49 years, stratum B: > 50 years), with the first and second vaccinations being administered according to a rapid immunization schedule (12 ± 2 days apart). The third vaccination will be administered approximately 6 months after the first dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Understand the nature of the study, agree to its provisions and provide written informed consent (assent if the subjects is under 18 years of age);
- Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age);
- Are aged >= 16 years (from the 16th birthday) at screening;
- Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial);
- Have a negative pregnancy test result at the first medical examination (if female and capable of bearing children);
Key exclusion criteria (15 listed)
- Have a history of any previous tick-borne encephalitis (TBE) vaccination;
- Have a history of TBE infection;
- Have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis);
- Have a history of allergic reactions, in particular to one of the components of the vaccine;
- Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions;
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 |
|---|---|---|
| Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl | Biological | – |
Primary outcome
Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined.
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 19 Apr 2023.
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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.
Baxter BioScience Investigator, MD principal investigator
Baxter BioScience
4 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 Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl in people with Encephalitis, Tick-Borne, run by Pfizer at 4 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 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does the primary outcome measure?
Immunogenicity: Seropositivity rate as determined by Enzyme-Linked Immunosorbent Assay (ELISA) and Neutralization test (NT) at Days 7, 14 and 21 after the second vaccination, in stratum A and B separately, and in the two age strata combined.. It is what the study was designed to measure, not a finding.
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 19 Apr 2023.