CLOSTRIDIUM DIFFICILE study to confirm the best vaccine dose, to evaluate immune system response, and to collect safety information about VLA84. The study treatment groups are assigned randomly, it is placebo controlled and safety evaluation is performed blinded.

• Conditions: Prevention against Clostridium difficile infection; MedDRA version: 17.1Level: PTClassification code 10054236Term: Clostridium difficile infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-003934-22-DE
• Lead Sponsor: Valneva Austria GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-22
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>To characterize the safety of VLA84 in healthy adults (aged =50 years) up to 6 months after the last vaccination<br>;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