a phase III bridging study for evaluation of safety and efficacy of Pseudovac Vaccine against Pseudomonas aeruginosa infection in burn patients.
- Conditions
- Health Condition 1: null- Burn
- Registration Number
- CTRI/2012/06/002723
- Lead Sponsor
- AllMed International Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 210
•Male or female patients aged between 18 to 60 yrs.
•Patients with thermal burns caused by flame or hot liquid or steam.
•Patients with or without Pseudomonas infections
•Patients who are admitted in the hospital within 24 hrs of the burns infliction.
•Patients with second and third degree burns covering between 11-60% of the total body surface.
•Abbreviated Burn Severity Index (ABSI) score between 4 and 10.
•Patients willing to give written, signed or thumb-printed and witnessed informed consent.
•Willing to comply with protocol requirements.
•Female subjects with child bearing potential are included only if serum- pregnancy test is negative at the time of enrollment and are willing to practice reliable method of contraception during the study period.
•Patients with electrical burns, chemical burns, and radiation burns.
•Acute infections complicated with fever.
•Patients with facial, genital or perineal burns.
•Pregnant women (positive pregnancy test) or nursing mothers.
•Serious acute or chronic illness (such as immuno-compromising diseases, life threatening trauma, or neoplastic disease) determined by clinical or physical examination and laboratory screening tests.
•Hypersensitivity to any of the substances used in the vaccine or any chemically related substances.
•Chronic administration of immune-suppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
•Patients whose laboratory test results are out of acceptable limits, performed at the time of screening.
•Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine or planned use during the study period.
•History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Burns due to suicide attempt.
•Current alcohol or drug abuse.
•Family history of immuno-deficiency.
•Any other findings that the Investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method