Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2018-000211-25-GB
EUCTR2018-000211-25-GB
Active, not recruiting
Phase 1

Observer blinded, randomised study to investigate safety, tolerability and long-term immunogenicity of different dose regimens and formulations of MV-CHIK in healthy volunteers

Themis Bioscience GmbH0 sites60 target enrollmentJune 1, 2018
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsThe study is being conducted in healthy volunteers for the prophylaxis of chikungunya virus (CHIKV) infection.Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
The study is being conducted in healthy volunteers for the prophylaxis of chikungunya virus (CHIKV) infection.
Sponsor
Themis Bioscience GmbH
Enrollment
60
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 1, 2018
End Date
November 16, 2019
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Signed informed consent obtained before any trial\-related activities
  • •2\. Healthy men or women aged 18 to 55 years on the day of consenting
  • •3\. Ability to comprehend the full nature and purpose of the study, including possible risks
  • •and side effects; ability to cooperate with the investigator and to comply with the
  • •requirements of the entire study
  • •4\. All female subjects must have a negative serum pregnancy test at screening
  • •5\. Willingness not to become pregnant or to father a child during the entire study period by
  • •practicing reliable methods of contraception as specified in protocol section 8\.11\.4
  • •6\. Availability during the duration of the trial
  • •Are the trial subjects under 18? no

Exclusion Criteria

  • •1\. Participation in another clinical study (including exposure to an investigational medicinal
  • •product ore device) within one month before the screening visit or planned concurrent
  • •participation in another clinical study before completion of the treatment period (day 56\)
  • •2\. History of immunodeficiency, known human immunodeficiency virus (HIV) infection or
  • •current hepatitis B/C infection
  • •3\. History of drug addiction including alcohol dependence within the last 2 years
  • •4\. Inability or unwillingness to avoid intake of more than around 20g alcohol per day during
  • •48 hours after each vaccination (equals roughly 0\.5 L beer or 0\.25 L of wine)
  • •5\. Vaccination within 4 weeks prior to first vaccination or planning to receive any non\-study
  • •vaccine until end of treatment period (day 56\)

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
Prospective randomized observer-blinded study comparing the analgesic efficacy of ultrasound-guided rectus sheath block to local anesthetic infiltration for laparoscopic percutaneous extraperitoneal closurelaparoscopic inguinal hernia surgery of children performed under general anesthesia
JPRN-UMIN000020912Hokkaido University34
Active, not recruiting
Not Applicable
A randomised assessor blinded study to examine the role of skin testing in the prediction of peri-operative anaphylaxis and its correlation with mast cell tryptase and total IgE. - Peri-operative screening for sensitization to NMDAsPrevalance of sensitivity of immune system to the four named neuromuscular blocking drugs in patients undergoing anaesthesia.
EUCTR2005-001622-91-GBRoyal Group Hospitals160
Not yet recruiting
Phase 4
A randomised controlled observer blinded trial comparing a standard technique with an ultrasound technique for axillary blockade in teaching hospitalsSURGICALSurgery - Surgical techniques
ACTRN12605000750684St Vincents Hospital, Melbourne450
Completed
Phase 2
The use of 5% tea tree oil for the prevention of infections in renal dialysis patientsInfection in renal dialysis patientsAlternative and Complementary Medicine - Other alternative and complementary medicineInfection - Studies of infection and infectious agentsRenal and Urogenital - Kidney disease
ACTRN12610000874011The University of Western Australia100
Active, not recruiting
Not Applicable
A prospective, randomized, observer-blind, reference-controlled (Provicol ®) Phase III clinical study on the efficacy and safety of Ledermix® Zementpulver after the treatment (preparation) of teeth with dentine carious lesions and / or defective filling margins and reversible hyperaemia - Ledermix ZementTeeth with dentine carious lesions without clinical symptoms of inflammation,and / or Teeth with defective filling margins
EUCTR2006-005091-41-DERIEMSER Arzneimittel AG