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CompletedNCT00840801Updated Jan 19, 2024Results posted

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

A Phase 3 interventional study of Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) and Tick-Borne Encephalitis (TBE) Vaccine (Inactivated) in Encephalitis, Tick-Borne, sponsored by Pfizer. Completed at 8 sites in 2 countries. Open to participants aged 1 Year to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-19.

Sponsored by Pfizer · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
302
Allocation
Randomized
Ages
1 Year to 11 Years
Sex
All
01

Study 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, administered according to the conventional schedule (0, 28 and 360 days).

02

Conditions studied

  • Encephalitis, Tick-Borne
03

In context

Encephalitis, Tick-Borne

51 studies on the registry are indexed under Encephalitis, Tick-Borne; 9 are open to participants now.

This study's enrollment of 302 is above the median of 192 across 32 interventional studies indexed under Encephalitis, Tick-Borne.

Browse Encephalitis, Tick-Borne studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 ;
  • 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).

Exclusion criteria

Exclusion Criteria:

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;
  • they are suffering from a disease (e.g. disease) or are undergoing a form of treatment (e.g. systemic ) 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 (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 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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Masking
Single (Participant)
Enrollment
302 participants (actual)

Study arms

  • Experimental
    1

    Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.

    Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

  • Experimental
    2

    Subjects receive three vaccinations with a paediatric TBE vaccine according to the conventional vaccination schedule.

    Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 28 days after Vaccination 2

Secondary outcomes

  1. 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.

    Time frame: 180 days after the Vaccination 1, 28 days after the Vaccination 3

  2. 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.

    Time frame: 28 days after Vaccination 2, 180 days after the Vaccination 1, 28 days after the Vaccination 3

  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.

    Time frame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3

  4. 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.

    Time frame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3

  5. 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.

    Time frame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3

  6. 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.

    Time frame: 28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3

  7. 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.

    Time frame: Within 28 days after Vaccination 1

  8. 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.

    Time frame: Within 28 days after Vaccination 2

  9. 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.

    Time frame: Within 28 days after Vaccination 3

  10. 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.

    Time frame: Within 6 days of Vaccination 1

  11. 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.

    Time frame: Within 6 days of Vaccination 2

  12. 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.

    Time frame: Within 6 days of Vaccination 3

  13. 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.

    Time frame: Part A: Within 28 days after Vaccination 1 and Vaccination 2, Part B: 28 days after Vaccination 2 to before Vaccination 3

  14. 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.

    Time frame: Within 28 days after Vaccination 3

07

Results

Posted Jan 19, 2024

Participant flow

Part A: Screening- Day 28 Postdose 2
Participant flow — Part A: Screening- Day 28 Postdose 2
MilestonePart A: FSME-IMMUNPart A: EncepurPart B: FSME-IMMUN
Started1501520
Completed1491520
Not completed100
Withdrew: Screen failure100
Part B:Day 28 Postdose2-Day 28 Postdose3
Participant flow — Part B:Day 28 Postdose2-Day 28 Postdose3
MilestonePart A: FSME-IMMUNPart A: EncepurPart B: FSME-IMMUN
Started00301
Completed00297
Not completed004
Withdrew: Lost to follow-up001
Withdrew: Other001
Withdrew: Refused blood draw002

Outcome measures

PrimarySeropositivity 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.

Time frame:
28 days after Vaccination 2
Reported as:
Number · Percentage of participants
Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination
Percentage of participantsFSME-IMMUNEncepur
Seropositivity Rate as Determined by Neutralization Test (NT) 28 Days After the Second Vaccination100 (97.1 to 100)97.8 (93.6 to 99.5)
Statistical analysis
  • FSME-IMMUN vs Encepur · Stratified score test · p = <0.001
SecondarySeropositivity 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.

Time frame:
180 days after the Vaccination 1, 28 days after the Vaccination 3
Reported as:
Number · Percentage of participants
Seropositivity Rate Determined by NT 180 Days After the First Vaccination and 28 Days After the Third Vaccination
Percentage of participantsFSME-IMMUNEncepur
180 Days after Vaccination 195.3 (90.2 to 98.3)91 (84.8 to 95.3)
28 Days after Vaccination 3100 (97.2 to 100)100 (97.2 to 100)
SecondarySeropositivity 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.

Time frame:
28 days after Vaccination 2, 180 days after the Vaccination 1, 28 days after the Vaccination 3
Reported as:
Number · percentage of participants
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 participantsFSME-IMMUNEncepur
180 Days after Vaccination 195.1 (90.1 to 98)81.5 (74.2 to 87.4)
28 Days after Vaccination 2100 (97.5 to 100)97.3 (93.2 to 99.3)
28 Days after Vaccination 3100 (97.4 to 100)100 (97.5 to 100)
SecondaryAntibody 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.

Time frame:
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Reported as:
Geometric mean · titer
Antibody Response Measured by NT 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
titerFSME-IMMUNEncepur
180 Days after Vaccination 139.7 (34.4 to 45.8)25 (21.3 to 29.4)
28 Days after Vaccination 2236.8 (199.6 to 281)118.8 (97.5 to 144.9)
28 Days after Vaccination 3538.2 (499.2 to 580.2)521.3 (476.6 to 570.2)
SecondaryAntibody 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.

Time frame:
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Reported as:
Geometric mean · titer
Antibody Response Measured by ELISA 28 Days After the Second Vaccination, 180 Days After the First Vaccination and 28 Days After the Third Vaccination
titerFSME-IMMUNEncepur
IMMUNOZYM: 180 Days after Vaccination 1493.7 (436.5 to 558.5)161.2 (140.5 to 184.9)
IMMUNOZYM: 28 Days after Vaccination 23026.3 (2652.2 to 3453.2)678 (561.2 to 819.2)
IMMUNOZYM: 28 Days after Vaccination 311292.9 (9693.5 to 13156.3)10508.6 (8208.4 to 13453.3)
Enzygnost: 180 Days after Vaccination 147.9 (41.4 to 55.4)26.7 (22.5 to 31.6)
Enzygnost: 28 Days after Vaccination 2163.3 (152.8 to 174.5)93.7 (81.6 to 107.5)
Enzygnost: 28 Days after Vaccination 3682.2 (579.6 to 802.9)673.2 (533.4 to 849.7)
SecondaryFold 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.

Time frame:
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Reported as:
Geometric mean · fold rise
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
fold riseFSME-IMMUNEncepur
180 Days after Vaccination 17.9 (6.8 to 9.1)5 (4.2 to 5.8)
28 Days after Vaccination 246.9 (39.5 to 55.8)23.6 (19.4 to 28.8)
28 Days after Vaccination 3106.7 (98.5 to 115.5)103.5 (94.6 to 113.2)
SecondaryFold 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.

Time frame:
28 days after Vaccination 2, 180 days after Vaccination 1, 28 days after Vaccination 3
Reported as:
Geometric mean · fold rise
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
fold riseFSME-IMMUNEncepur
IMMUNOZYM: 180 Days after Vaccination 131.6 (26.8 to 37.2)9.5 (8.1 to 11)
IMMUNOZYM: 28 Days after Vaccination 2193.7 (163 to 230.1)39.9 (32.5 to 49)
IMMUNOZYM: 28 Days after Vaccination 3719.9 (591.5 to 876.3)620.9 (479.7 to 803.6)
Enzygnost: 180 Days after Vaccination 19.5 (8.2 to 11)5.3 (4.5 to 6.3)
Enzygnost: 28 Days after Vaccination 232.5 (30.4 to 34.8)18.7 (16.3 to 21.5)
Enzygnost: 28 Days after Vaccination 3135.8 (115.3 to 160)134.6 (106.7 to 169.9)
SecondaryFrequency 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.

Time frame:
Within 28 days after Vaccination 1
Reported as:
Number · participants
Frequency and Severity of Systemic Reactions Occurring After First Vaccination
participantsFSME-IMMUNEncepur
Systemic reactions: None136 (6.8 to 9.1)134 (4.2 to 5.8)
Systemic reactions: Mild13 (39.5 to 55.8)15 (19.4 to 28.8)
Systemic reactions: Moderate1 (98.5 to 115.5)3 (94.6 to 113.2)
Systemic reactions: Severe00
SecondaryFrequency 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.

Time frame:
Within 28 days after Vaccination 2
Reported as:
Number · participants
Frequency and Severity of Systemic Reactions Occurring After Second Vaccination
participantsFSME-IMMUNEncepur
Systemic reactions: None143 (6.8 to 9.1)144 (4.2 to 5.8)
Systemic reactions: Mild7 (39.5 to 55.8)8 (19.4 to 28.8)
Systemic reactions: Moderate0 (98.5 to 115.5)0 (94.6 to 113.2)
Systemic reactions: Severe00
SecondaryFrequency 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.

Time frame:
Within 28 days after Vaccination 3
Reported as:
Number · participants
Frequency and Severity of Systemic Reactions Occurring After Third Vaccination
participantsFSME-IMMUN
Systemic reactions: None282 (6.8 to 9.1)
Systemic reactions: Mild15 (39.5 to 55.8)
Systemic reactions: Moderate1 (98.5 to 115.5)
Systemic reactions: Severe0
SecondaryFrequency 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.

Time frame:
Within 6 days of Vaccination 1
Reported as:
Number · participants
Frequency and Severity of Injection Site Reactions Occurring After the First Vaccination
participantsFSME-IMMUNEncepur
None131 (6.8 to 9.1)108 (4.2 to 5.8)
Unknown1 (39.5 to 55.8)0 (19.4 to 28.8)
Mild18 (98.5 to 115.5)41 (94.6 to 113.2)
Moderate03
Severe00
SecondaryFrequency 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.

Time frame:
Within 6 days of Vaccination 2
Reported as:
Number · participants
Frequency and Severity of Injection Site Reactions Occurring After the Second Vaccination
participantsFSME-IMMUNEncepur
None137 (6.8 to 9.1)118 (4.2 to 5.8)
Mild12 (98.5 to 115.5)27 (94.6 to 113.2)
Moderate17
Severe00
SecondaryFrequency 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.

Time frame:
Within 6 days of Vaccination 3
Reported as:
Number · participants
Frequency and Severity of Injection Site Reactions Occurring After the Third Vaccination
participantsFSME-IMMUN
None249 (6.8 to 9.1)
Mild43 (39.5 to 55.8)
Moderate4 (98.5 to 115.5)
Severe2
SecondaryFrequency 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.

Time frame:
Part A: Within 28 days after Vaccination 1 and Vaccination 2, Part B: 28 days after Vaccination 2 to before Vaccination 3
Reported as:
Number · participants
Frequency and Severity of Adverse Events (AE) Observed Before the Third Vaccination
participantsFSME-IMMUNEncepur
Non-Serious AE: within 28 days after Vaccination 157 (6.8 to 9.1)80 (4.2 to 5.8)
Serious AE: within 28 days after Vaccination 11 (39.5 to 55.8)0 (19.4 to 28.8)
Non-Serious AE: within 28 days after Vaccination 242 (98.5 to 115.5)66 (94.6 to 113.2)
Serious AE: within 28 days after Vaccination 200
Non-Serious AE:after Part A to before Vaccination397102
Serious AE: after Part A to before Vaccination 3610
SecondaryFrequency 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.

Time frame:
Within 28 days after Vaccination 3
Reported as:
Number · participants
Frequency and Severity of Adverse Events (AE) Observed After the Third Vaccination
participantsFSME-IMMUN
Non-Serious AE: within 28 days after Vaccination 3102 (6.8 to 9.1)
Serious AE: within 28 days after Vaccination 30 (39.5 to 55.8)

Adverse events

Collected over 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. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part A (1-2 Years of Age) FSME-IMMUN: After Vaccination 1—1/50 (2%)17/50 (34%)
Part A (1-2 Years of Age) FSME-IMMUN: After Vaccination 2—0/50 (0%)13/50 (26%)
Part B (1-2 Years of Age) FSME-IMMUN: Before Vaccination 3—1/50 (2%)37/50 (74%)
Part A (3-6 Years of Age) FSME-IMMUN: After Vaccination 1—0/51 (0%)15/51 (29.4%)
Part A (3-6 Years of Age) FSME-IMMUN: After Vaccination 2—0/51 (0%)11/51 (21.6%)
Part B (3-6 Years of Age) FSME-IMMUN: Before Vaccination 3—3/51 (5.9%)30/51 (58.8%)
Part A (7-11 Years of Age) FSME-IMMUN: After Vaccination 1—0/49 (0%)14/49 (28.6%)
Part A (7-11 Years of Age) FSME-IMMUN: After Vaccination 2—0/49 (0%)10/49 (20.4%)
Part B (7-11 Years of Age) FSME-IMMUN: Before Vaccination 3—2/48 (4.2%)30/48 (62.5%)
Part A (1-2 Years of Age) Encepur: After Vaccination 1—0/50 (0%)25/50 (50%)
Part A (1-2 Years of Age) Encepur: After Vaccination 2—0/50 (0%)13/50 (26%)
Part B (1-2 Years of Age) Encepur: Before Vaccination 3—4/50 (8%)39/50 (78%)
Part A (3-6 Years of Age) Encepur: After Vaccination 1—0/51 (0%)33/51 (64.7%)
Part A (3-6 Years of Age) Encepur: After Vaccination 2—0/51 (0%)19/51 (37.3%)
Part B (3-6 Years of Age) Encepur: Before Vaccination 3—3/51 (5.9%)33/51 (64.7%)
Part A (7-11 Years of Age) Encepur: After Vaccination 1—0/51 (0%)30/51 (58.8%)
Part A (7-11 Years of Age) Encepur: After Vaccination 2—0/51 (0%)26/51 (51%)
Part B (7-11 Years of Age) Encepur: Before Vaccination 3—3/51 (5.9%)30/51 (58.8%)
Part B (1-2 Years of Age) FSME-IMMUN: After Vaccination 3—0/99 (0%)23/99 (23.2%)
Part B (3-6 Years of Age) FSME-IMMUN: After Vaccination 3—0/100 (0%)29/100 (29%)
Part B (7-11 Years of Age) FSME-IMMUN: After Vaccination 3—0/99 (0%)30/99 (30.3%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventPart A (1-2 Years of Age) FSME-IMMUN: After Vaccination 1Part A (1-2 Years of Age) FSME-IMMUN: After Vaccination 2Part B (1-2 Years of Age) FSME-IMMUN: Before Vaccination 3Part A (3-6 Years of Age) FSME-IMMUN: After Vaccination 1Part A (3-6 Years of Age) FSME-IMMUN: After Vaccination 2Part B (3-6 Years of Age) FSME-IMMUN: Before Vaccination 3Part A (7-11 Years of Age) FSME-IMMUN: After Vaccination 1Part A (7-11 Years of Age) FSME-IMMUN: After Vaccination 2Part B (7-11 Years of Age) FSME-IMMUN: Before Vaccination 3Part A (1-2 Years of Age) Encepur: After Vaccination 1Part A (1-2 Years of Age) Encepur: After Vaccination 2Part B (1-2 Years of Age) Encepur: Before Vaccination 3Part A (3-6 Years of Age) Encepur: After Vaccination 1Part A (3-6 Years of Age) Encepur: After Vaccination 2Part B (3-6 Years of Age) Encepur: Before Vaccination 3Part A (7-11 Years of Age) Encepur: After Vaccination 1Part A (7-11 Years of Age) Encepur: After Vaccination 2Part B (7-11 Years of Age) Encepur: Before Vaccination 3Part B (1-2 Years of Age) FSME-IMMUN: After Vaccination 3Part B (3-6 Years of Age) FSME-IMMUN: After Vaccination 3Part B (7-11 Years of Age) FSME-IMMUN: After Vaccination 3
BRONCHITISInfections and infestations0/500/500/500/510/510/510/490/490/480/500/502/500/510/510/510/510/510/510/990/1000/99
CONCUSSIONInjury, poisoning and procedural complications0/500/500/500/510/510/510/490/491/480/500/500/500/510/510/510/510/510/510/990/1000/99
ACQUIRED PHIMOSISReproductive system and breast disorders0/500/500/500/510/510/510/490/491/480/500/500/500/510/510/510/510/510/510/990/1000/99
HYPOSPADIASCongenital, familial and genetic disorders0/500/501/500/510/510/510/490/490/480/500/500/500/510/510/510/510/510/510/990/1000/99
EUSTACHIAN TUBE DISORDEREar and labyrinth disorders0/500/500/500/510/510/510/490/490/480/500/501/500/510/510/510/510/510/510/990/1000/99
HERPANGINAInfections and infestations0/500/500/500/510/510/510/490/490/480/500/501/500/510/510/510/510/510/510/990/1000/99
LARYNGITISInfections and infestations1/500/500/500/510/510/510/490/490/480/500/500/500/510/510/510/510/510/510/990/1000/99
TONSILLAR HYPERTROPHYRespiratory, thoracic and mediastinal disorders0/500/500/500/510/510/510/490/490/480/500/501/500/510/510/510/510/510/510/990/1000/99
ADENOIDAL DISORDERRespiratory, thoracic and mediastinal disorders0/500/500/500/510/510/510/490/490/480/500/501/500/510/511/510/510/510/510/990/1000/99
CRYPTORCHISMCongenital, familial and genetic disorders0/500/500/500/510/510/510/490/490/480/500/500/500/510/510/510/510/511/510/990/1000/99
Most frequent other events
Showing 10 of 143
Most frequent other events
EventPart A (1-2 Years of Age) FSME-IMMUN: After Vaccination 1Part A (1-2 Years of Age) FSME-IMMUN: After Vaccination 2Part B (1-2 Years of Age) FSME-IMMUN: Before Vaccination 3Part A (3-6 Years of Age) FSME-IMMUN: After Vaccination 1Part A (3-6 Years of Age) FSME-IMMUN: After Vaccination 2Part B (3-6 Years of Age) FSME-IMMUN: Before Vaccination 3Part A (7-11 Years of Age) FSME-IMMUN: After Vaccination 1Part A (7-11 Years of Age) FSME-IMMUN: After Vaccination 2Part B (7-11 Years of Age) FSME-IMMUN: Before Vaccination 3Part A (1-2 Years of Age) Encepur: After Vaccination 1Part A (1-2 Years of Age) Encepur: After Vaccination 2Part B (1-2 Years of Age) Encepur: Before Vaccination 3Part A (3-6 Years of Age) Encepur: After Vaccination 1Part A (3-6 Years of Age) Encepur: After Vaccination 2Part B (3-6 Years of Age) Encepur: Before Vaccination 3Part A (7-11 Years of Age) Encepur: After Vaccination 1Part A (7-11 Years of Age) Encepur: After Vaccination 2Part B (7-11 Years of Age) Encepur: Before Vaccination 3Part B (1-2 Years of Age) FSME-IMMUN: After Vaccination 3Part B (3-6 Years of Age) FSME-IMMUN: After Vaccination 3Part B (7-11 Years of Age) FSME-IMMUN: After Vaccination 3
INJECTION SITE PAINGeneral disorders1/502/500/503/513/510/5110/495/490/484/501/500/5010/516/510/5124/5124/510/512/9913/10027/99
TRACHEITISInfections and infestations1/502/5017/500/510/517/510/490/491/481/503/5013/500/512/516/510/510/510/515/990/1000/99
TONSILLITISInfections and infestations0/502/5010/500/510/512/511/490/495/483/500/5012/500/510/513/511/511/512/513/992/1000/99
PHARYNGITISInfections and infestations0/500/500/501/510/512/513/490/499/481/500/500/500/511/515/511/510/515/510/996/1001/99
PYREXIAGeneral disorders9/502/500/504/513/513/514/491/495/489/503/500/505/513/512/514/512/513/513/998/1000/99
OTITIS MEDIAInfections and infestations1/503/508/501/510/510/510/490/490/485/501/508/501/511/512/510/510/510/515/992/1000/99
NASOPHARYNGITISInfections and infestations0/500/502/502/511/517/510/491/496/480/500/505/501/511/517/513/511/517/510/992/1003/99
HEADACHENervous system disorders0/500/500/500/512/510/516/493/490/480/500/500/501/514/510/515/512/511/510/993/1007/99
ACUTE TONSILLITISInfections and infestations0/500/505/501/510/514/510/490/491/482/501/505/500/510/514/510/510/512/510/990/1000/99
RESTLESSNESSPsychiatric disorders2/502/500/500/510/510/510/490/490/485/501/500/500/510/510/510/510/510/511/990/1000/99

Baseline characteristics

The safety analysis set included all participants who received the third vaccination of FSME-IMMUN, after first 2 doses of FSME-IMMUN or Encepur and had documented adverse event information at least immediately afterwards.

Age, Customized
Age, Customized(Participants)Part A: FSME-IMMUNPart A: EncepurTotal
Infants and toddlers (28 days- 23 months)5050100
Children (2-11 years)100102202
Sex: Female, Male
Sex: Female, Male(Participants)Part A: FSME-IMMUNPart A: EncepurTotal
Female7774151
Male7378151
08

Study locations

8 sites
  • Unterer Graben 2
    Eferding, Upper Austria 4070, Austria
  • Grieskirchnerstr.17
    Wels, Upper Austria 4600, Austria
  • Private surgery of General Practitioner for children and juveniles
    Havlickuv Brod, 580 01, Czechia
  • University Hospital Hradec Kralove, Vaccinal center, Clinic of infectious diseases, Sokolská 581
    Hradec Králové, 50005, Czechia
  • Chemiku 129
    Pardubice-Polabiny, 530 09, Czechia
  • Private surgery of General Practitioner for children and juveniles
    Pardubice, 530 02, Czechia
  • Private surgery of General Practitioner for children and juveniles
    Pardubice, 530 03, Czechia
  • Private surgery of General Practitioner for children and juveniles
    Pardubice, 530 09, Czechia
09

References and documents

Individual participant data

Plan to share: 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.

Data sharing details ↗ · www.pfizer.com

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00840801
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 10, 2009
Start date
Feb 6, 2009
Primary completion
May 20, 2010
Completion
May 20, 2010
Results posted
Jan 19, 2024
Last update
Jan 19, 2024

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
Baxter Bioscience Investigator
principal investigator · Baxter BioScience

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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