ClinicalTrials.gg
Sign In
CompletedNCT00894686Updated Dec 17, 2018Results posted

Tick-Borne Encephalitis (TBE) Seropersistence After First Booster and Response to a Second Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)

A Phase 4 interventional study of FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL) in Encephalitis, Tick-Borne, sponsored by Pfizer. Completed at 4 sites in 3 countries. Per ClinicalTrials.gov, last updated 2018-12-17.

Sponsored by Pfizer · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
179
Allocation
Non-randomized
Sex
All
01

Study summary

The main purpose of this study is to assess the seropersistence of TBE virus antibodies in children, adolescents and young adults who received the first booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.

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 179 is close to 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
Child (0–17), Adult (18–64), Older adult (65+)
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

Subjects who participated in precursor Study 700401 and meet ALL of the following criteria are eligible for participation in this study:

  • Subject / parent(s) / legal guardian(s) provide(s) written (according to national law);
  • Subject provides written assent to the study according to age and capacity of understanding;
  • Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml during the course of precursor Study 700401;
  • Blood was drawn after the first booster vaccination in precursor Study 700401;
  • Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the Subject Diary).

Exclusion criteria

Exclusion Criteria:

Subjects who participated in precursor Study 700401 and meet ANY of the following criteria are not eligible for participation in this study:

  • Subject received any TBE vaccination since his / her first booster vaccination in precursor Study 700401;
  • Subject has a history of infection with or vaccination against other flaviviruses (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first booster vaccination in precursor Study 700401;
  • Subject is known to be positive since his / her first booster vaccination in precursor Study 700401 (a special HIV test is not required for the purpose of the study);
  • Subject received a blood product or immunoglobulins within 90 days before any blood draw or in the period between the blood draw and the booster vaccination (as applicable);
  • Subject has a known or suspected problem with drug or alcohol abuse (> 4 liters of wine/week or equivalent level of other alcoholic beverages);
  • Subject / parent(s) / legal guardian(s) is / 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 the site conducting the study.
Terms in these criteria, in plain language(2)

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.

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.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Masking
None (open label)
Enrollment
179 participants (actual)

Study arms

  • Experimental
    All subjects

    Assessment of seropersistence of TBE antibodies at yearly intervals from approximately 3 years (38 months) to 10 years (118 months) after the first booster vaccination (in Study 700401), as well as antibody response to a second booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL, depending on the subject´s age. Timing of the second booster vaccination will depend on the level of serum TBE antibodies detected at the defined assessment time points. Subjects who are not protected against TBE for an entire further season (NT titer \<= 20 and/or ELISA value \<=126 VIE U/mL) will be invited to receive the second booster vaccination at either the 40, 48, 60, 72, 84, 96, 108, or 120-month time point.

    Biological: FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)

Interventions

  • BiologicalFSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL)

    Dosage form: solution/suspension; injectable. Dosage frequency: once. Mode of administration: intramuscular.

06

What researchers measure

Primary outcomes

  1. Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Seropositivity rate was reported as percentage of participants with NT level greater than equal to (\>=) 10 at 21-35 days after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants.

    Time frame: 21-35 days after first TBE booster vaccination

  2. Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Seropositivity rate was reported as percentage of participants with NT level \>=10 at 38 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants.

    Time frame: 38 months after first TBE booster vaccination

  3. Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Seropositivity rate was reported as percentage of participants with NT level \>=10 at 46 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

    Time frame: 46 months after first TBE booster vaccination

  4. Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Seropositivity rate was reported as percentage of participants with NT level \>=10 at 58 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

    Time frame: 58 months after first TBE booster vaccination

  5. Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Seropositivity rate was reported as percentage of participants with NT level \>=10 at 70 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

    Time frame: 70 months after first TBE booster vaccination

  6. Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Seropositivity rate was reported as percentage of participants with NT level \>=10 at 82 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

    Time frame: 82 months after first TBE booster vaccination

  7. Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Seropositivity rate was reported as percentage of participants with NT level \>=10 at 94 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

    Time frame: 94 months after first TBE booster vaccination

  8. Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Seropositivity rate was reported as percentage of participants with NT level \>=10 at 106 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

    Time frame: 106 months after first TBE booster vaccination

  9. Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Seropositivity rate was reported as percentage of participants with NT level \>=10 at 118 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

    Time frame: 118 months after first TBE booster vaccination

  10. Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

    Seropositivity rate was reported as percentage of participants with NT level \>=10 at 21-35 days after the second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

    Time frame: 21-35 days after second TBE booster vaccination

Secondary outcomes

  1. Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Seropositivity rate was reported as percentage of participants with ELISA level greater than (\>) 126 vienna units per milliliter (VIE U/mL) at each blood sampling time point after first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

    Time frame: 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination

  2. Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

    Seropositivity rate was reported as percentage of participants with ELISA level \>126 VIE U/mL at 21-35 days after second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

    Time frame: 21-35 days after second TBE booster vaccination

  3. Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Antibody against TBE booster vaccination was measured as geometric mean concentration (GMC) by ELISA level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations.

    Time frame: 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination

  4. Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

    Antibody against TBE booster vaccination was measured as GMC by ELISA level after the second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations.

    Time frame: 21-35 days after second TBE booster vaccination

  5. Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

    Antibody against TBE booster vaccination was measured as geometric mean titer (GMT) by NT level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers.

    Time frame: 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination

  6. Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

    Antibody against TBE booster vaccination was measured as GMT by NT level after second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers.

    Time frame: 21-35 days after second TBE booster vaccination

  7. Geometric Mean Fold Rise (GMFR) in Antibody Concentrations After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

    GMFR in antibody concentration from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises.

    Time frame: Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination

  8. Geometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT)

    GMFR in antibody titers from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises.

    Time frame: Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination

  9. Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

    Injection site reactions included swelling, induration, redness, injection site pain, tenderness, ecchymosis and hematoma. Systemic reaction included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, malaise and fatigue. Participants with any injection site reaction and systemic reaction after second TBE booster vaccination in Study 700802 were reported in this outcome measure.

    Time frame: From second booster vaccination up to 21-35 days after the vaccination

07

Results

Posted Dec 17, 2018

Participant flow

Participant flow — Overall Study
MilestoneFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Started179
Completed123
Not completed56
Withdrew: Withdrawal by subject50
Withdrew: Physician decision1
Withdrew: Other5

Outcome measures

PrimarySeropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level greater than equal to (\>=) 10 at 21-35 days after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants.

Time frame:
21-35 days after first TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401100.0 (97.9 to 100.0)
PrimarySeropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level \>=10 at 38 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants.

Time frame:
38 months after first TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401100.0 (97.8 to 100.0)
PrimarySeropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level \>=10 at 46 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Time frame:
46 months after first TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401100.0 (97.5 to 100.0)
PrimarySeropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level \>=10 at 58 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Time frame:
58 months after first TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 70040199.4 (96.5 to 100.0)
PrimarySeropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level \>=10 at 70 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Time frame:
70 months after first TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 70040198.1 (94.5 to 99.6)
PrimarySeropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level \>=10 at 82 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Time frame:
82 months after first TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 70040196.8 (92.7 to 99.0)
PrimarySeropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level \>=10 at 94 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Time frame:
94 months after first TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 70040195.5 (91.0 to 98.2)
PrimarySeropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level \>=10 at 106 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Time frame:
106 months after first TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 70040194.9 (90.1 to 97.8)
PrimarySeropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with NT level \>=10 at 118 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Time frame:
118 months after first TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 70040190.3 (84.5 to 94.5)
PrimarySeropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Seropositivity rate was reported as percentage of participants with NT level \>=10 at 21-35 days after the second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Time frame:
21-35 days after second TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802100.0 (86.8 to 100.0)
SecondarySeropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Seropositivity rate was reported as percentage of participants with ELISA level greater than (\>) 126 vienna units per milliliter (VIE U/mL) at each blood sampling time point after first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Time frame:
21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
After 21-35 days98.8 (95.8 to 99.9)
After 38 months97.0 (93.1 to 99.0)
After 46 months100.0 (97.5 to 100.0)
After 58 months97.5 (93.6 to 99.3)
After 70 months96.8 (92.7 to 99.0)
After 82 months96.2 (91.8 to 98.6)
After 94 months96.2 (91.8 to 98.6)
After 106 months91.7 (86.2 to 95.5)
After 118 months87.7 (81.5 to 92.5)
SecondarySeropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Seropositivity rate was reported as percentage of participants with ELISA level \>126 VIE U/mL at 21-35 days after second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants.

Time frame:
21-35 days after second TBE booster vaccination
Reported as:
Number · Percentage of participants
Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
Percentage of participantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802100.0 (86.8 to 100.0)
SecondaryGeometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Antibody against TBE booster vaccination was measured as geometric mean concentration (GMC) by ELISA level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations.

Time frame:
21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination
Reported as:
Geometric mean · VIE U/mL
Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
VIE U/mLFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
After 21-35 days4368.2 (3605.22 to 5292.63)
After 38 months1081.5 (933.04 to 1253.51)
After 46 months1212.1 (1055.77 to 1391.65)
After 58 months1005.1 (876.16 to 1153.08)
After 70 months883.4 (767.09 to 1017.25)
After 82 months728.6 (626.66 to 847.12)
After 94 months636.8 (541.70 to 748.55)
After 106 months561.0 (469.95 to 669.58)
After 118 months506.4 (414.96 to 618.10)
SecondaryGeometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Antibody against TBE booster vaccination was measured as GMC by ELISA level after the second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations.

Time frame:
21-35 days after second TBE booster vaccination
Reported as:
Geometric mean · VIE U/mL
Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
VIE U/mLFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 7008021844.1 (1305.54 to 2604.91)
SecondaryGeometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401

Antibody against TBE booster vaccination was measured as geometric mean titer (GMT) by NT level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers.

Time frame:
21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401
TitersFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
After 21-35 days380.7 (336.73 to 430.31)
After 38 months162.1 (139.29 to 188.58)
After 46 months108.1 (92.41 to 126.34)
After 58 months111.3 (96.10 to 128.84)
After 70 months123.4 (105.31 to 144.59)
After 82 months122.3 (102.33 to 146.28)
After 94 months82.8 (68.88 to 99.57)
After 106 months56.0 (46.42 to 67.57)
After 118 months53.9 (43.40 to 66.87)
SecondaryGeometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Antibody against TBE booster vaccination was measured as GMT by NT level after second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers.

Time frame:
21-35 days after second TBE booster vaccination
Reported as:
Geometric mean · Titers
Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
TitersFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802126.8 (94.76 to 169.64)
SecondaryGeometric Mean Fold Rise (GMFR) in Antibody Concentrations After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

GMFR in antibody concentration from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises.

Time frame:
Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination
Reported as:
Geometric mean · Fold rise
Geometric Mean Fold Rise (GMFR) in Antibody Concentrations After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Fold riseFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Geometric Mean Fold Rise (GMFR) in Antibody Concentrations After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)8.6 (6.69 to 11.10)
SecondaryGeometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT)

GMFR in antibody titers from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises.

Time frame:
Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination
Reported as:
Geometric mean · Fold rise
Geometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT)
Fold riseFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Geometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT)5.2 (2.78 to 9.67)
SecondaryNumber of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802

Injection site reactions included swelling, induration, redness, injection site pain, tenderness, ecchymosis and hematoma. Systemic reaction included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, malaise and fatigue. Participants with any injection site reaction and systemic reaction after second TBE booster vaccination in Study 700802 were reported in this outcome measure.

Time frame:
From second booster vaccination up to 21-35 days after the vaccination
Reported as:
Number · Participants
Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802
ParticipantsFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Injection site reactions1
Systemic reactions0

Adverse events

Collected over From second booster vaccination up to 21-35 days after the vaccination. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL0/26 (0%)0/26 (0%)1/26 (3.8%)
Most frequent other events
Most frequent other events
EventFSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
TendernessInfections and infestations1/26

Baseline characteristics

Full analysis set included all participants enrolled into the study.

Age, Continuous
Age, Continuous(Years)FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Mean15.1 ± 4.4
Sex: Female, Male
Sex: Female, Male(Participants)FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
Female88
Male91
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL
08

Study locations

4 sites
  • Grieskirchnerstr.17
    Oberösterreich, Austria
  • Untergraben 2
    Oberösterreich, Austria
  • Dr. Ulrich Behre
    Baden-Württemberg, Germany
  • Niepubliczny Zakład Opieki Zdrowotnej Ośrodek Zdrowia w Lipsku
    Zamosc, Poland
09

References and documents

Publications

  • Poellabauer E, Angermayr R, Behre U, Zhang P, Harper L, Schmitt HJ, Erber W. Seropersistence and booster response following vaccination with FSME-IMMUN in children, adolescents, and young adults. Vaccine. 2019 May 27;37(24):3241-3250. doi: 10.1016/j.vaccine.2019.03.032. Epub 2019 Mar 27. PubMed 30928173 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00894686
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
May 7, 2009
Start date
Apr 26, 2009
Primary completion
May 10, 2017
Completion
May 10, 2017
Results posted
Dec 17, 2018
Last update
Dec 17, 2018

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
Eva-Maria Pöllabauer, MD
study director · Baxter Healthcare Corporation

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Encephalitis, Tick-Borne →

Other studies from this sponsor

Pfizer →

Start the discussion