SCOTTSDALE, Ariz., Aug. 28, 2015 /PRNewswire-USNewswire/ -- Passport Health, in partnership with vaccine manufacturer PaxVax, Inc. is participating in a clinical study to test the effects of the oral typhoid vaccination, Vivotif® (Typhoid Vaccine Live Oral Ty21a). The study will look at the side effects that could occur when taking Vivotif across the range of approved potencies. The study is part of a post-marketing commitment to the U.S. Food and Drug Administration.
Participants will be required to keep a 21-day log of any potential side effects they may feel from the vaccine. For their time, Passport Health will provide to participants a free Vivotif vaccination as well as stipend for completing the study. Those eligible to participate are Passport Health clients within the following areas: Baltimore, MD, San Diego, CA, and Tustin, CA.
"This is a unique opportunity for both Passport Health and our clients," said Melanie French, Vice President of Clinic Operations for Passport Health. "Our clients will be able to give feedback directly to PaxVax on this vaccine. Our nurses often help individuals with any feedback they may have, but being able to give it directly to the manufacturer is something that will help both PaxVax and future travel clients."
The study will last from August 2015 to approximately August 2016 and will involve approximately 950 participants located within the three regions listed above.
For more information on the study, please see here.
To find the Passport Health location nearest to you and to access the latest travel and health information, please visit www.passporthealthusa.com, or call 1-877-499-PASS(7277).
About Passport Health:
Passport Health is the largest and leading provider of travel medicine and vaccination services in the North America. With over 250 clinic locations, 20+ years of experience, a commitment to first class medical care, and rigorously trained medical staff, Passport Health sets the immunization industry standard. Passport Health's core services have grown from travel medicine to include on-site flu clinics, specialty physical exams, routine immunizations, and vaccination records management solutions for public and private sector clients of all sizes.
Indications and Usage
Vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi. Routine typhoid vaccination is not recommended in the United States of America. Selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to S. typhi, 2) persons with intimate exposure (e.g. household contact) to a S. typhi carrier, and 3) microbiology laboratorians who work frequently with S. typhi (7). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps.
Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. The vaccine will not afford protection against species of Salmonella other than Salmonella typhi or other bacteria that cause enteric disease. The vaccine is not suitable for treatment of acute infections with S. typhi.
Important Safety Information*
The vaccine should not be given to persons with hypersensitivity to any component of the vaccine or the enteric-coated capsule. The vaccine should not be administered to persons during an acute febrile illness. Safety of the vaccine has not been demonstrated in persons deficient in their ability to mount a humoral or cell-mediated immune response, due to either a congenital or acquired immunodeficient state including treatment with immunosuppressive or antimitotic drugs. The vaccine should not be administered to these persons regardless of benefits.
Vivotif® (Typhoid Vaccine Live Oral Ty21a) is not to be taken during an acute gastrointestinal illness. The vaccine should not be administered to individuals receiving sulfonamides and antibiotics since these agents may be active against the vaccine strain and prevent a sufficient degree of multiplication to occur in order to induce a protective immune response. Postpone taking the vaccine if persistent diarrhea or vomiting is occurring. Unless a complete immunization schedule is followed, an optimum immune response may not be achieved. Not all recipients of Vivotif® will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms, i.e. travelers should take all necessary precautions to avoid contact or ingestion of potentially contaminated food or water. The health care provider should take all necessary precautions to ensure the safe and effective use of the vaccine.
*For additional Important Safety Information, please see full Prescribing Information.
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SOURCE Passport Health