A/H5N1/LT Dose Ranging Study (NCT00908687) | Clinical Trial Compass
CompletedPhase 2
A/H5N1/LT Dose Ranging Study
United States500 participantsStarted 2009-05
Plain-language summary
This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).
Who can participate
Age range18 Years – 49 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy adult male or females 18 to 49 years of age (inclusive)
* Signed Informed Consent
* Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours of vaccination with understanding (through informed Consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide) and IUD
Exclusion Criteria:
* Clinically significant laboratory abnormalities at screening
* Abnormalities at physical examination \[as determined by the Toxicity Grading Scale (grade 1-4)\]
* Known allergies to any component of the vaccine
* Known egg protein allergy
* Known allergies to adhesives
* Known disturbance of coagulation
* Participated in research involving investigational product within 45 days before planned date of vaccination
* Donated or received blood or blood products such as plasma within the past 45 days
* Received any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to planned date of vaccination
* Ever received investigational enterotoxigenic E. coli, or LT (R192G) or NasalFlu, Berna Biotech Ltd
* Ever received cholera toxin or vaccine (e.g. Orochol, Dukoral)
*…
What they're measuring
1
Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.