Encephalitis, Tick-BornePhase 3NCT00840801

Immunogenicity, Safety and Interchangeability of Two Tbe Vaccines Administered According to a Conventional Schedule in Children

A Phase 3 study testing Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in people with Encephalitis, Tick-Borne, run by Pfizer at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to assess the immunogenicity, safety and interchangeability of two different TBE vaccines in children aged 1-11 years, the first and second vaccination with either FSME-IMMUN 0.25ml Junior or Encepur 0.25ml Children and the third vaccination with FSME-IMMUN 0.25 ml Junior only… Read more about this study

Who is it for?: Ages 1 year to 11 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 302 participants
Where: 8 sitesin 2 countries
Study dates: 6 Feb 2009to 20 May 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 year to 11 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male and female children will be eligible for participation in this study if:
they are aged >= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening;
their parents / legal guardians provide written informed consent;
children provide written assent to the study according to age and capacity of understanding;
their parents/guardians understand the nature of the clinical study and will comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits);
they are generally healthy, (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study);
provide a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children).

Who cannot join

Subjects will be excluded from participation if:
they have a history of any previous TBE vaccination;
they have a history of TBE infection;
they have a history of infection with other flaviviruses;
they have a history of vaccination against yellow fever and/or Japanese B encephalitis;
they have a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines;

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they are suffering 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;
they have received any blood product or immunoglobulins within 90 days prior to study entry;
they are known to be Human Immunodeficiency Virus (HIV) positive (an HIV test is not required specifically for the purpose of this study);
they have a functional or surgical asplenia;
they have a rash or other dermatological condition at the injection site which could interfere with injection site reaction evaluation;
they were administered an investigational product within six weeks prior to study start or are concurrently participating in another clinical study that includes the administration of an investigational product;
they are pregnant or breastfeeding (if a female subject);
they or their parents/legal guardian(s) are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner/spouse, siblings) as well as employees of the investigator or site conducting the study.
Subjects who have an acute illness with or without elevated body temperature (>=37.5°C) within 3 days prior to the scheduled first vaccination will not be vaccinated. Subjects may be included at a repeat visit provided that (1) the illness has resolved (body temperature < 37.5 °C), (2) the repeat visit is no more than 14 calendar days after the Screening Visit, and (3) the center is still open for recruitment.
If subjects have received antipyretics within 4 hours prior to the scheduled time of vaccination, the vaccination should be performed at a later date, as long as the center is still open for recruitment.
Subjects who received any live vaccine within 4 weeks or any inactivated vaccine within 2 weeks prior to the scheduled first study vaccination will not be vaccinated until an interval of 4 or 2 weeks, respectively, has passed, provided the center is still open for recruitment.
If a subject was bitten by a tick within 4 weeks prior to the scheduled first or second vaccination, the vaccination must be postponed until an interval of 4 weeks has passed.

Trial locations and contacts

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

Czechia6 sites

Private surgery of General Practitioner for children and juveniles
Havlíčkův Brod, 580 01
University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581
Hradec Králové, 50005
Private surgery of General Practitioner for children and juveniles
Pardubice, 530 02
Private surgery of General Practitioner for children and juveniles
Pardubice, 530 03
Private surgery of General Practitioner for children and juveniles
Pardubice, 530 09
Chemiku 129
Pardubice-Polabiny, 530 09

Other trials in Czechia

Austria2 sites

Unterer Graben 2
Eferding, Upper Austria, 4070
Grieskirchnerstr.17
Wels, Upper Austria, 4600

Other trials in Austria

About this study

Official title: SINGLE-BLIND, RANDOMIZED, PHASE III B STUDY IN CHILDREN AGED 1 - 11 YEARS TO INVESTIGATE THE IMMUNOGENICITY, SAFETY AND INTERCHANGEABILITY OF TWO TICK-BORNE ENCEPHALITIS (TBE) VACCINES ADMINISTERED ACCORDING TO A CONVENTIONAL SCHEDULE

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
Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)Biological
Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.

Study groups in NCT00840801
Study group	Role	What they receive
1	Experimental	Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule. Receives: Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)
2	Experimental	Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule. Receives: Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

What is being measured

The primary outcome is the main question the study is designed to answer.

Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination
Percentage of participants achieving NT titer greater than or equal to (>=) 10.
Measured: 28 days after Vaccination 2

Secondary outcomes (14)

Seropositivity Rate Determined by NT 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Percentage of participants with NT titer >=10. Here, "number of participants analyzed" signifies total number of participants included in the modified intent-to-treat (mITT) population and "Number Analyzed" signifies number of participants who were evaluable at specified timeframe.
Measured: 180 days after the Vaccination 1, 28 days after the Vaccination 3
Seropositivity Rate Determined by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Percentage of participants with IMMUNOZYM ELISA >126 Vienna Units per milliliter (VIEU/mL) or Enzygnost ELISA >10.32 Units per milliliter (U/mL). Here, "Number Analyzed" signifies number of participants who were evaluable at the specified timeframe.
Measured: 28 days after Vaccination 2, 180 days after the Vaccination 1, 28 days after the Vaccination 3
Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Geometric mean of antibody response measured by NT. Here, "Number Analyzed" signifies number of participants who were evaluable at the specified timeframe.
Measured: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Geometric mean of antibody response measured by IMMUNOZYM ELISA (VIEU/mL) and Enzygnost ELISA (U/mL). Here, "Number Analyzed" signifies number of participants who were evaluable at specified timeframe for the specified ELISA assay.
Measured: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Fold Increase of Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
Geometric mean of fold increase of antibody response measured by NT from day 0 to specified timeframe. Here, "Number Analyzed" signifies number of participants who were evaluable at specified timeframe.
Measured: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Fold Increase of Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
Geometric mean of fold increase of antibody response measured by IMMUNOZYM ELISA (VIEU/ml) and Enzygnost ELISA (U/ml) from day 0 to specified timeframe. Here, "Number Analyzed" signifies number of participants who were evaluable at the specified timeframe for the specified ELISA assay.
Measured: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Frequency and Severity of Systemic Reactions Occurring After First Vaccination
Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 to 2 years of age; malaise and fatigue in participants 3 to 11 years of age as collected in participant diary. Number of participants with systemic reactions according to severity after first vaccination were reported.
Measured: Within 28 days after Vaccination 1
Frequency and Severity of Systemic Reactions Occurring After Second Vaccination
Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 to 2 years of age; malaise and fatigue in participants 3 to 11 years of age as collected in participant diary. Number of participants with systemic reactions according to severity after second vaccination were reported.
Measured: Within 28 days after Vaccination 2
Frequency and Severity of Systemic Reactions Occurring After Third Vaccination
Systemic symptoms included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, loss of appetite and changes in sleeping behavior in all age strata; restlessness in children 1 to 2 years of age; malaise and fatigue in participants 3 to 11 years of age as collected in participant diary. Number of participants with systemic reactions according to severity after third vaccination were reported. Here, "number of participants analyzed" signifies those participants who received FSME-IMMUN or Encepur during the first and second vaccination and received FSME-IMMUN at Day 360 as third vaccination.
Measured: Within 28 days after Vaccination 3
Frequency and Severity of Injection Site Reactions Occurring After the First Vaccination
Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in participant diary. Number of participants with injection site reactions according to severity after first vaccination were reported.
Measured: Within 6 days of Vaccination 1
Frequency and Severity of Injection Site Reactions Occurring After the Second Vaccination
Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in participant diary. Number of participants with injection site reactions according to severity after second vaccination were reported.
Measured: Within 6 days of Vaccination 2
Frequency and Severity of Injection Site Reactions Occurring After the Third Vaccination
Injection site reactions included swelling, induration, redness, injection site pain and tenderness, ecchymosis and hematoma as collected in participant diary. Number of participants with injection site reactions according to severity after third vaccination were reported. Here, "number of participants analyzed" signifies those participants who received FSME-IMMUN or Encepur during the first and second vaccination and received FSME-IMMUN at Day 360 as third vaccination.
Measured: Within 6 days of Vaccination 3
Frequency and Severity of Adverse Events (AE) Observed Before the Third Vaccination
An AE was any untoward medical occurrence in a participants who received study vaccination without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study vaccine and up to one month after last dose that were absent before treatment or that worsened relative to pre-treatment state. Number of participants with serious and non-serious adverse events according to severity before third vaccination were reported.
Measured: Part A: Within 28 days after Vaccination 1 and Vaccination 2, Part B: 28 days after Vaccination 2 to before Vaccination 3
Frequency and Severity of Adverse Events (AE) Observed After the Third Vaccination
An AE was any untoward medical occurrence in a participants who received study vaccination without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability / incapacity; congenital anomaly. Treatment-emergent are events between first dose of study vaccine and up to one month after last dose that were absent before treatment or that worsened relative to pre-treatment state. Number of participants with serious and non-serious adverse events according to severity after third vaccination were reported. Here, "number of participants analyzed" signifies those participants who received FSME-IMMUN or Encepur during the first and second vaccination and received FSME-IMMUN at Day 360 as third vaccination.
Measured: Within 28 days after Vaccination 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 200920 May 2010

First posted10 Feb 2009 (estimated)
Study start6 Feb 2009
Primary completion20 May 2010
Study completion20 May 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Randomised
Masking: Single blind
Who is masked: Participant
Enrolment: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00840801
Sponsor's protocol ID: 700801
Other IDs: B9371022, 2008-002691-10, EUDRACT NUMBER: 2008-002691-10, 2008
Status last verified: Apr 2023
First submitted: 9 Feb 2009
Last updated: 19 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Encephalitis, Tick-Borne trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SINGLE-BLIND, RANDOMIZED, PHASE III B STUDY IN CHILDREN AGED 1 - 11 YEARS TO INVESTIGATE THE IMMUNOGENICITY, SAFETY AND INTERCHANGEABILITY OF TWO TICK-BORNE ENCEPHALITIS (TBE) VACCINES ADMINISTERED ACCORDING TO A CONVENTIONAL SCHEDULE
ClinicalTrials.gov ID: NCT00840801
Acronym / sponsor ID: 700801
Conditions: Encephalitis, Tick-Borne
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 6 Feb 2009 (actual)
Primary completion: 20 May 2010 (actual)
Study completion: 20 May 2010 (actual)
First posted: 10 Feb 2009 (estimated)
Results: Posted 19 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.
2	Experimental	Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.

Who may qualify

Ages: 1 year to 11 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

they are aged >= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening;
their parents / legal guardians provide written informed consent;
children provide written assent to the study according to age and capacity of understanding;
their parents/guardians understand the nature of the clinical study and will comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits);
they are generally healthy, (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study);

Key exclusion criteria (18 listed)

they have a history of any previous TBE vaccination;
they have a history of TBE infection;
they have a history of infection with other flaviviruses;
they have a history of vaccination against yellow fever and/or Japanese B encephalitis;
they have a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines;

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)Subjects receive three vaccinations with FSME-IMMUN 0.25ml Junior on days 0, 28 and 360	Biological	1
Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)Subjects receive two vaccinations with Encepur 0.25ml Children on days 0 and 28 and a third vaccination with FSME-IMMUN 0.25ml Junior on day 360.	Biological	2

Primary outcome

Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination
Time frame: 28 days after Vaccination 2
Percentage of participants achieving NT titer greater than or equal to (>=) 10.

14 secondary outcomes

Seropositivity Rate Determined by NT 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Time frame: 180 days after the Vaccination 1, 28 days after the Vaccination 3
Seropositivity Rate Determined by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Time frame: 28 days after Vaccination 2, 180 days after the Vaccination 1, 28 days after the Vaccination 3
Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Time frame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Time frame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Fold Increase of Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
Time frame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Fold Increase of Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination as Compared to Baseline
Time frame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Frequency and Severity of Systemic Reactions Occurring After First Vaccination
Time frame: Within 28 days after Vaccination 1
Frequency and Severity of Systemic Reactions Occurring After Second Vaccination
Time frame: Within 28 days after Vaccination 2
Frequency and Severity of Systemic Reactions Occurring After Third Vaccination
Time frame: Within 28 days after Vaccination 3
Frequency and Severity of Injection Site Reactions Occurring After the First Vaccination
Time frame: Within 6 days of Vaccination 1
Frequency and Severity of Injection Site Reactions Occurring After the Second Vaccination
Time frame: Within 6 days of Vaccination 2
Frequency and Severity of Injection Site Reactions Occurring After the Third Vaccination
Time frame: Within 6 days of Vaccination 3
Frequency and Severity of Adverse Events (AE) Observed Before the Third Vaccination
Time frame: Part A: Within 28 days after Vaccination 1 and Vaccination 2, Part B: 28 days after Vaccination 2 to before Vaccination 3
Frequency and Severity of Adverse Events (AE) Observed After the Third Vaccination
Time frame: Within 28 days after Vaccination 3

Results and safety

Results posted to the registry on 19 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: FSME-IMMUN	150	149
Part A: Encepur	152	152
Part B: FSME-IMMUN	0	0

Primary outcome: Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination

Time frame: 28 days after Vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	FSME-IMMUN n = 127	Encepur n = 134
Value	100 (97.1 to 100)	97.8 (93.6 to 99.5)

FSME-IMMUN vs Encepur: p <0.001, Stratified score test

Population analysed: Per-protocol analysis set included eligible participants who received first and second vaccination; had negative baseline values in NT; had immunogenicity measurements available at baseline; 28 days after second vaccination and no major protocol violations.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Part A: Within 28 days after Vaccination 1 and Vaccination 2, Part B: 28 days after Vaccination 2 to before the Vaccination 3, within 28 days after Vaccination 3. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A (1-2 Years of Age) FSME-IMMUN: After Vaccination 1	1 of 50 (2%)	17 of 50 (34%)	Not reported
Part A (1-2 Years of Age) FSME-IMMUN: After Vaccination 2	0 of 50 (0%)	13 of 50 (26%)	Not reported
Part B (1-2 Years of Age) FSME-IMMUN: Before Vaccination 3	1 of 50 (2%)	37 of 50 (74%)	Not reported
Part A (3-6 Years of Age) FSME-IMMUN: After Vaccination 1	0 of 51 (0%)	15 of 51 (29.4%)	Not reported
Part A (3-6 Years of Age) FSME-IMMUN: After Vaccination 2	0 of 51 (0%)	11 of 51 (21.6%)	Not reported
Part B (3-6 Years of Age) FSME-IMMUN: Before Vaccination 3	3 of 51 (5.9%)	30 of 51 (58.8%)	Not reported
Part A (7-11 Years of Age) FSME-IMMUN: After Vaccination 1	0 of 49 (0%)	14 of 49 (28.6%)	Not reported
Part A (7-11 Years of Age) FSME-IMMUN: After Vaccination 2	0 of 49 (0%)	10 of 49 (20.4%)	Not reported
Part B (7-11 Years of Age) FSME-IMMUN: Before Vaccination 3	2 of 48 (4.2%)	30 of 48 (62.5%)	Not reported
Part A (1-2 Years of Age) Encepur: After Vaccination 1	0 of 50 (0%)	25 of 50 (50%)	Not reported
Part A (1-2 Years of Age) Encepur: After Vaccination 2	0 of 50 (0%)	13 of 50 (26%)	Not reported
Part B (1-2 Years of Age) Encepur: Before Vaccination 3	4 of 50 (8%)	39 of 50 (78%)	Not reported
Part A (3-6 Years of Age) Encepur: After Vaccination 1	0 of 51 (0%)	33 of 51 (64.7%)	Not reported
Part A (3-6 Years of Age) Encepur: After Vaccination 2	0 of 51 (0%)	19 of 51 (37.3%)	Not reported
Part B (3-6 Years of Age) Encepur: Before Vaccination 3	3 of 51 (5.9%)	33 of 51 (64.7%)	Not reported
Part A (7-11 Years of Age) Encepur: After Vaccination 1	0 of 51 (0%)	30 of 51 (58.8%)	Not reported
Part A (7-11 Years of Age) Encepur: After Vaccination 2	0 of 51 (0%)	26 of 51 (51%)	Not reported
Part B (7-11 Years of Age) Encepur: Before Vaccination 3	3 of 51 (5.9%)	30 of 51 (58.8%)	Not reported
Part B (1-2 Years of Age) FSME-IMMUN: After Vaccination 3	0 of 99 (0%)	23 of 99 (23.2%)	Not reported
Part B (3-6 Years of Age) FSME-IMMUN: After Vaccination 3	0 of 100 (0%)	29 of 100 (29%)	Not reported
Part B (7-11 Years of Age) FSME-IMMUN: After Vaccination 3	0 of 99 (0%)	30 of 99 (30.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

Baxter Bioscience Investigator principal investigator

Baxter BioScience

8 sites in 2 countries: 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 2 countries.

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 7 inclusion and 18 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 Jan 2024. 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 Czechia, 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 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?

Yes. Results are posted in the registry (first posted 19 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination (time frame: 28 days after Vaccination 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00840801.

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 Jan 2024.