Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02511587
Recruitment Status : Completed
First Posted : July 30, 2015
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Univ. Prof. Dr. Ursula Wiedermann, Medical University of Vienna

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Vaccine Efficacy
Intervention Biological: FSME-Immune vaccination
Enrollment 116
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intra Muscular Application Subcutaneous Application
Hide Arm/Group Description

intra muscular application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

subcutaneous application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

Period Title: Overall Study
Started 58 58
Completed 58 58
Not Completed 0 0
Arm/Group Title Intra Muscular Application Subcutaneous Application Total
Hide Arm/Group Description

intra muscular application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

subcutaneous application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

Total of all reporting groups
Overall Number of Baseline Participants 58 58 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 116 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
58
 100.0%
58
 100.0%
116
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 58 participants 116 participants
Female
29
  50.0%
29
  50.0%
58
  50.0%
Male
29
  50.0%
29
  50.0%
58
  50.0%
1.Primary Outcome
Title Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine
Hide Description GMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intra Muscular Application Subcutaneous Application
Hide Arm/Group Description:

intra muscular application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

subcutaneous application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

Overall Number of Participants Analyzed 58 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: Geometric mean titers
574.8
(439 to 751)
612.0
(483 to 775)
2.Secondary Outcome
Title Cellular Immune Responses - Cytokines
Hide Description cytokine production of antigen-specifically restimulated PMBC (peripheral blood mononuclear cells) is evaluated (Interleukin 2, Interleukin 10, Interferon gamma)
Time Frame before (day 0) and 1 week after booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intra Muscular Application Subcutaneous Application
Hide Arm/Group Description:

intra muscular application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

subcutaneous application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

Overall Number of Participants Analyzed 58 58
Mean (Standard Deviation)
Unit of Measure: pg/ml
IFNg before vaccination 2376  (2099) 2199  (1781)
IFNg one week post vacc 3071  (2347) 3387  (4375)
IL-2 before vaccination 81.8  (111.4) 57.6  (66.1)
IL-2 one week post vacc 77.0  (97.8) 56.5  (54.0)
IL-10 before vaccination 183.5  (219.8) 192.8  (307.7)
IL-10 one week post vacc 210.6  (210.3) 297.4  (343.3)
3.Secondary Outcome
Title TBE Titer Profile
Hide Description TBE specific neutralizing antibody titer profiles (geometric mean titers, GMT)
Time Frame before (day 0) and 1week, 1 month, 6 months after booster vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intra Muscular Application Subcutaneous Application
Hide Arm/Group Description:

intra muscular application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

subcutaneous application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

Overall Number of Participants Analyzed 58 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: Geometric mean titers
GMT at d0
249.9
(185.3 to 337.1)
208.8
(159.2 to 273.8)
GMT after 1 week
360.9
(278.8 to 467.2)
317.2
(245.1 to 410.6)
GMT after one month
574.8
(439.5 to 751.6)
612.0
(483 to 775.4)
GMT after 6 month
420.1
(318.5 to 554.2)
380.5
(293.5 to 493.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intra Muscular Application Subcutaneous Application
Hide Arm/Group Description

intra muscular application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

subcutaneous application of FSME-Immune vaccination

FSME-Immune vaccination: booster vaccination with FSME-Immune

All-Cause Mortality
Intra Muscular Application Subcutaneous Application
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intra Muscular Application Subcutaneous Application
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/58 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intra Muscular Application Subcutaneous Application
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/58 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Univ.-Prof. Dr. Ursula Wiedermann
Organization: Medical University of Vienna
Phone: 0043 1 40160 38291
EMail: ursula.wiedermann@meduniwien.ac.at
Layout table for additonal information
Responsible Party: Univ. Prof. Dr. Ursula Wiedermann, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02511587     History of Changes
Other Study ID Numbers: RV_FSME_1.2
First Submitted: July 23, 2015
First Posted: July 30, 2015
Results First Submitted: March 27, 2018
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018