Prevention against Clostridium difficile infection MedDRA version: 17.1 Level: PT Classification code 10054236 Term: Clostridium difficile infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: VLA84 with Aluminium Hydroxide
Product Code: VLA84 w/ Alum
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Injection
Route of administration of the plac
Sponsors
Valneva Austria GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged =50 years of good general health, including subjects with pharmacologically controlled conditions like hypercholesterolemia, hypertension, or type 2 diabetes mellitus. 2. Informed consent form has been signed and dated Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: 1. Subjects with any confirmed or suspected prior Clostridium difficile infection episode 2. Previous vaccination against Clostridium difficile with any (investigational) vaccine or receipt of (investigational) monoclonal antibodies against Clostridium difficile toxins 3. Use of any other investigational or non-registered medicinal product within 30 days prior to VLA84 vaccination at Visit 1 (Day 0) and throughout the entire study period. 4. Active or passive vaccination four weeks before first vaccination at Visit 1 and during the entire study period, except for influenza (seasonal or pandemic) and pneumococcal vaccines which may be administered outside a 7-days interval before and after any trial vaccination 5. Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile) 6. Known thrombocytopenia, bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion or until Visit 4 (Day28), contraindicating IM vaccination as judged by the investigator 7. Clinically relevant renal, hepatic, cardiac, pulmonary or central nervous disorders, as judged by the investigator. Subjects with hypercholesterolemia, hypertension, or type 2 diabetes mellitus requiring medication are allowed if disease is adequately controlled 8. Receipt of blood or blood-derived products in the past 3 months or anticipation of such products during the study period 9. Known congenital, hereditary or acquired immunodeficiency, including known infection with human immunodeficiency virus (HIV), administration of chronic (defined as longer than 14 days) immunosuppressants or other immune-modifying drugs within 30 days prior to VLA84 vaccination at Visit 1 (Day 0) and during the study until Visit 5 (Day 35). For corticosteroids this means prednisone or equivalent = 0.05 mg/kg/day; topical and inhaled steroids are allowed. Periodic steroid injections, e.g., intra-articular, are are not allowed within 30 days prior to first VLA84 vaccination at Visit 1 (Day 0) and until Visit 5 (Day 35) 10. History of autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded 11. Any malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled 12. Known hypersensitivity or allergic reactions to one of the components of the vaccine 13. Inability or unwillingness to provide informed consent 14. Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities) 15.Persons who are in a dependent relationship with the sponsor, an investigator or other study team members (i.e., children, partner/spouse, siblings, parents) as well as employees of the investigator or study center personnel
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity Endpoints: + SCR for IgG against both Toxin A and Toxin B on Days 0, 14, 28, 35, 120 and 210 + SCR for IgG against Toxin A on Days 0, 14, 28, 35, 56, 120 and 210 + SCR for IgG against Toxin B on Days 0, 14, 28, 35, 56, 120 and 210 + Geometric Mean Titer (GMT) for IgG against Toxin A as determined by ELISA on Days 0, 14, 28, 35, 56, 120 and 210 + Geometric Mean Titer (GMT) for IgG against Toxin B as determined by ELISA on Days 0, 14, 28, 35, 56, 120 and 210 + Responder Rate (defined as proportion of subjects achieving a =4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against both Toxin A and Toxin B on Days 0, 35, 56, 120* and 210 + Responder Rate for Toxin A neutralizing antibodies on Days 0, 35, 56, 120* and 210 + Responder Rate for Toxin B neutralizing antibodies on Days 0, 35, 56, 120* and 210 + GMT for Toxin A neutralizing antibodies as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210 + GMT for Toxin B neutralizing antibodies as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210 + SCR for IgG against Toxin A, against Toxin B and against both Toxin A and Toxin B on Days 0, 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older) + GMT for IgG against Toxin A and against Toxin B on Days 0, 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older) + Responder Rate for neutralizing antibodies against Toxin A, against Toxin B and against both Toxin A and Toxin B on Days 0, 35, 56, 120* and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older) + GMTs for Toxin A neutralizing antibodies and for Toxin B neutralizing antibodies as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older) Safety Endpoints: + Rate of SAEs to Day 56 and Day 210 + R | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the optimal dose and formulation of VLA84 in healthy adults (aged =50 years);Secondary Objective: To investigate the immunogenicity of VLA84 in healthy adults (aged =50 years) up to 6 months after the last vaccination To characterize the safety of VLA84 in healthy adults (aged =50 years) up to 6 months after the last vaccination ;Primary end point(s): Seroconversion Rate (SCR, defined as proportion of subjects achieving a =4-fold increase in antibody titer from Day 0) for IgG against both Toxin A and Toxin B on Day 56 ;Timepoint(s) of evaluation of this end point: Day 56 | — |
Countries
Germany, United States
Contacts
Public Contactapplicant
Assign Clinical Research GmbH
Outcome results
None listed