Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2009-017052-27-DE
EUCTR2009-017052-27-DE
Active, not recruiting
Not Applicable

A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a H1N1 Influenza Vaccine in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers - Focetria Tx

Medizinische Hochschule Hannover0 sitesDecember 1, 2009
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsVaccination for H1N1sw of immunocompromised adults who have undergone solid organ or bone marrow transplantation and of healthy adultsMedDRA version: 12.1Level: LLTClassification code 10022000Term: Influenza
DrugsFocetria suspension for injection in pre-filled syringe

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vaccination for H1N1sw of immunocompromised adults who have undergone solid organ or bone marrow transplantation and of healthy adults
Sponsor
Medizinische Hochschule Hannover
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 1, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Medizinische Hochschule Hannover

Eligibility Criteria

Inclusion Criteria

  • •Transplant Recipients
  • •\- Adult subjects 18\-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment
  • •\- Patients able to visit the outpatient clinic with a life expectancy of at least one year
  • •\- Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection
  • •Healthy Adults:
  • •\- Adult subjects 18\-60 years of age
  • •\- Healthy individuals as determined by medical history, physical assessment and clinical judgment of the investigator
  • •\- Within the same age category (\+/\- 5 years) than the incidental transplanted patient
  • •Transplant Recipients and Healthy Adults:
  • •\- Individuals who are able to comply with all study procedures and are available for all clinic visits scheduled in the study

Exclusion Criteria

  • •\- Individuals who received any vaccine within 30 days prior to study entry
  • •\- Individuals who received a H1N1 vaccination less than 6 months prior to the study
  • •\- Influenza diagnosed by a physician within 4 months prior to the study start
  • •\- Pregnant or lactating females
  • •\- History of an anaphylactic (i.e. life\-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)
  • •\- Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study
  • •\- History of or any current illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
  • •\- Temperature is \= 38 °C or oral temperature \= 38\.5 °C within 3 days of intended study vaccination
  • •\- Administration of parenteral immunoglobulin compound – including HBIg, blood products, and/or plasma derivatives within 6 months prior to Visit 1 or planned during the full length of the study
  • •\- HIV infection, as previously determined or reported

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a Seasonal Influenza Vaccine including H1N1 in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers - Fluad Tx
EUCTR2010-022871-78-DEMedizinische Hochschule Hannover
Unknown
Phase 2
DNK-651-3
JPRN-jRCT2080223664DENKA SEIKEN CO.,LTD.500
Active, not recruiting
Not Applicable
A phase II, open, study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine when administered as a booster dose to children aged 16-20 months, previously primed with GSK Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine, containing diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’ Kft [GD] or with GSK Biologicals licensed DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) in the primary vaccination study DTPa-HBV-IPV-116 (106786). - DTPa-HBV-IPV-120 BST:116Booster immunisation of healthy toddlers in the second year of life against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b.
EUCTR2007-005343-16-FIGlaxoSmithKline Biologicals450
Completed
Phase 2
A Phase 2 study to assess the safety, immunogenicity and recommended dose of DS-5670a in Japanese healthy adults
JPRN-jRCT2071210086Inoguchi Akihiro80
Active, not recruiting
Phase 1
A phase II trial to assess the safety, immunological activity of Trovax plus Pemetrexed/ Cisplatin in patients with malignant pleural mesothelioma. - SKOPOS Trial
EUCTR2010-023230-22-GBVelindre NHS Trust29