Vaccine EfficacyPhase 4NCT02511587

Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®

A Phase 4 study testing FSME-Immune vaccination in people with Vaccine Efficacy, run by Medical University of Vienna.

Completed

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

Trial summary

FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Vaccine Efficacy
What is being tested?: FSME-Immune vaccination
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 116 participants
Where: No sites listed yet
Study dates: Oct 2012to Jun 2015
Phase: Phase 4
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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

completed primary TBE immunization + at least one booster immunization
adults of both sexes between 18 and 60 years of age
willingness to sign written informed consent form

Who cannot join

age < 18 and > 60 years
prior TBE infection
pregnancy and breast feeding
acute infection on day of inclusion (day 0), (body temperature > 37,9°C)
concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study
administration of other vaccines 4 weeks before/after day 0

Show all 14Show fewer

planned surgery within 2 weeks before/after TBE booster vaccination
specific immunotherapy (Hypo-/Desensibilisation) 14 days before/after vaccination
any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
history of malignant disease within the last 5 years
autoimmune diseases
drug addictions
plasma donors
receipt of blood transfusions or immuno globulins within 3 month before study entry

About this study

FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response.

Read the detailed description

Tick-borne encephalitis (TBE) vaccine (FSME-Immun®) is registered for intra-muscular application. Due to medical reasons (e.g. anticoagulant therapy, adipositas) intra-muscular application is not always possible. The aim of this clinical trial is to investigate whether a comparably good immunogenicity can be achieved via the subcutaneous vaccination route. Thus humoral and cellular immune responses after intramuscular and subcutaneous TBE vaccination in healthy volunteers will be compared.

Conditions: Vaccine Efficacy
Being tested: FSME-Immune vaccination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FSME-Immune vaccinationBiological
booster vaccination with FSME-Immune

Study groups in NCT02511587
Study group	Role	What they receive
intra muscular application	Active comparator	intra muscular application of FSME-Immune vaccination Receives: Biological: FSME-Immune vaccination
subcutaneous application	Experimental	subcutaneous application of FSME-Immune vaccination Receives: Biological: FSME-Immune vaccination

What is being measured

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

Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine
GMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination
Measured: 1 month

Secondary outcomes (2)

Cellular Immune Responses - Cytokines
cytokine production of antigen-specifically restimulated PMBC (peripheral blood mononuclear cells) is evaluated (Interleukin 2, Interleukin 10, Interferon gamma)
Measured: before (day 0) and 1 week after booster vaccination
TBE Titer Profile
TBE specific neutralizing antibody titer profiles (geometric mean titers, GMT)
Measured: before (day 0) and 1week, 1 month, 6 months after booster vaccination

Timeline

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

Oct 2012Jun 2015

First posted30 Jul 2015 (estimated)
Study startOct 2012
Primary completionJun 2015
Study completionJun 2015

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 Vaccine EfficacyStudies of the same condition, open and under way.
More trials run by Medical University of ViennaThe 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02511587
Sponsor's protocol ID: RV_FSME_1.2
Status last verified: May 2018
First submitted: 23 Jul 2015
Last updated: 18 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

Official record

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All Vaccine Efficacy trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®
ClinicalTrials.gov ID: NCT02511587
Acronym / sponsor ID: RV_FSME_1.2
Conditions: Vaccine Efficacy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Medical University of ViennaUniversity, hospital or other
Study start: Oct 2012
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 30 Jul 2015 (estimated)
Results: Posted 18 May 2018

Clinical summary

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

FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
intra muscular application	Active comparator	Biological: FSME-Immune vaccinationintra muscular application of FSME-Immune vaccination
subcutaneous application	Experimental	Biological: FSME-Immune vaccinationsubcutaneous application of FSME-Immune vaccination

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

completed primary TBE immunization + at least one booster immunization
adults of both sexes between 18 and 60 years of age
willingness to sign written informed consent form

Key exclusion criteria (14 listed)

age < 18 and > 60 years
prior TBE infection
pregnancy and breast feeding
acute infection on day of inclusion (day 0), (body temperature > 37,9°C)
concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FSME-Immune vaccinationbooster vaccination with FSME-Immune	Biological	intra muscular application, subcutaneous application

Primary outcome

Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine
Time frame: 1 month
GMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination

2 secondary outcomes

Cellular Immune Responses - Cytokines
Time frame: before (day 0) and 1 week after booster vaccination
TBE Titer Profile
Time frame: before (day 0) and 1week, 1 month, 6 months after booster vaccination

Results and safety

Results posted to the registry on 18 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intra Muscular Application	58	58
Subcutaneous Application	58	58

Primary outcome: Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine

Time frame: 1 month. Geometric mean (95% Confidence Interval). Unit: Geometric mean titers

Measure	Intra Muscular Application n = 58	Subcutaneous Application n = 58
Value	574.8 (439 to 751)	612.0 (483 to 775)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intra Muscular Application	0 of 58 (0%)	0 of 58 (0%)	Not reported
Subcutaneous Application	0 of 58 (0%)	0 of 58 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Vaccine Efficacy

RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Recruiting
Assessment of Communication Interventions on Vaccination Knowledge and Acceptance
Vaccination Knowledge and Acceptance, Informed Vaccine-decision Making
RecruitingPhase 3
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Clostridoides Difficile Associated Disease
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum

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.

Ursula Wiedermann, MD, PhD principal investigator

Medical University Vienna, ISPTM

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FSME-Immune vaccination in people with Vaccine Efficacy, run by Medical University of Vienna.

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 3 inclusion and 14 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 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 18 May 2018). 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?

Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine (time frame: 1 month). 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 NCT02511587.

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 18 May 2018.