Encephalitis, Tick-bornePhase 2/3NCT00161746
Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years
A Phase 2/3 study testing Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in people with Encephalitis, Tick-borne, run by Pfizer at 7 sites in Austria.
Trial summary
The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products. Read more about this study
- Who is it for?
- Ages 6 to 47 monthsHealthy 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
- Not given
- Where
- 7 sitesAustria
- Study dates
- Apr 1998to Jun 1999
- Phase
- Phase 2/3
- 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 6 to 47 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female children aged between 6 and 47 months
- No history of any previous TBE vaccination
- Clinically healthy
- Informed consent provided by the parents
Who cannot join
- History of allergic reactions, in particular allergic reactions to one of the components of the vaccine
- Suffering from a disease that cannot be effectively treated or stabilised
- Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions
- Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system
- HIV-positivity (no special HIV test required for the purpose of the study)
- Suffering from a febrile disease
- History of vaccination against yellow fever and/or Japanese encephalitis
- Participation in another clinical trial
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Austria7 sites
Wiener Strasse 50/2
Kapfenberg, 8605
Erzherzog Johann Strasse 9
Leoben, 8700
Fronleichnamsweg 10
Liezen, 8940
Hauptstrasse 61
Linz, 4040
Brauhausgasse 1
Mürzzuschlag, 8680
Conrad-von-Hötzendorf Strasse
Voitsberg, 8570
Grieskirchner Strasse 17
Wels, 4600
About this study
Official title: Multicentre Randomized Double-Blind Phase II/III Study on the Safety and Immunogenicity of Three Vaccinations With TICOVAC in Two Dosages in Healthy Children Aged Between Six Months and Three Years
The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.
- 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 startApr 1998
- Study completionJun 1999
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Baxter BioScience Investigator, Principal investigator, Baxter Healthcare Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161746
- Sponsor's protocol ID
- 146A
- 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
- Multicentre Randomized Double-Blind Phase II/III Study on the Safety and Immunogenicity of Three Vaccinations With TICOVAC in Two Dosages in Healthy Children Aged Between Six Months and Three Years
- ClinicalTrials.gov ID
- NCT00161746
- Acronym / sponsor ID
- 146A
- Conditions
- Encephalitis, Tick-borne
- Keywords
- Tick-Borne Encephalitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 1998
- Study completion
- Jun 1999
- 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 evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 47 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male and female children aged between 6 and 47 months
- No history of any previous TBE vaccination
- Clinically healthy
- Informed consent provided by the parents
Key exclusion criteria (8 listed)
- History of allergic reactions, in particular allergic reactions to one of the components of the vaccine
- Suffering from a disease that cannot be effectively treated or stabilised
- Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions
- Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system
- HIV-positivity (no special HIV test required for the purpose of the study)
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.
Baxter BioScience Investigator principal investigator
Baxter Healthcare Corporation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in people with Encephalitis, Tick-borne, run by Pfizer at 7 sites in Austria.
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 4 inclusion and 8 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 Austria. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.