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Patient Enrollment in Phase 3 Study Complete, Comparison of Next-Generation, Intranasal Influenza Vaccine to Injectable Vaccine
"To have enrolled nearly 8,500 children in a pivotal Phase 3 clinical trial in one week's time is a great accomplishment," commented Dr. Robert Walker, senior director of clinical research and the project's director, "because it allows all children in the study to receive their first dose of vaccine before the influenza season starts in earnest. This could not have been achieved without the tremendous cooperation of parents and children involved in the study, as well as the incredible effort of hundreds of participating investigational physicians, nurses and their dedicated staffs. Our hope is that the result of our combined activities will show that CAIV-T may offer an improved influenza vaccination strategy with an acceptable safety profile for young children."
About the CAIV-T Phase 3 Comparison Trial
MedImmune's pivotal Phase 3 trial is a randomized, double-blind study designed to assess the comparable safety and relative efficacy of CAIV-T and the injectable influenza vaccine during the 2004/2005 influenza season. The study, being conducted at 249 sites in 16 countries in the Northern Hemisphere, has enrolled 8,492 children between the ages of 6 months through 59 months. Participants have been randomized one-to-one to receive either CAIV-T or the injectable influenza vaccine. A placebo mist and injection will be used to preserve the double-blind design of the study. Participants will be followed throughout the influenza season and evaluated to identify illnesses caused by influenza virus.
This Phase 3 trial is one of eight clinical trials currently being conducted by MedImmune with either FluMist or CAIV-T that are building upon data collected from a large number of previously completed studies. Twenty- one clinical trials involving approximately 30,000 subjects have already been completed for FluMist, while an additional twenty-one trials involving approximately another 34,000 subjects have already been completed for CAIV-T.
About the FluMist HIV Comparison Trial
MedImmune has entered into a collaboration with the Pediatric AIDS Clinical Trials Group (PACTG) to compare FluMist to the injectable influenza vaccine in HIV-infected children. This Phase 1/2 trial is a randomized, open label study designed to evaluate the safety, immunogenicity and vaccine virus shedding in HIV-infected children. The study will enroll approximately 300 HIV-infected children from 5 to 18 years of age at approximately 50 participating PACTG sites in the United States. Each participant will be followed for six months after dosing.
In a previous clinical study, FluMist was safely administered to 24 HIV- infected children aged 1 to 8 years. Signs and symptoms in the HIV-infected children in this study were similar to those seen in healthy children who have received FluMist, and there were no vaccine-related serious adverse events. Similar results were obtained in a study involving 57 HIV-infected adults.
FluMist is the first live, attenuated influenza vaccine indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age.
For the 2004-2005 influenza season, the CDC has encouraged the use of intranasally administered, live, attenuated influenza vaccine (FluMist), if available, for healthy, non-pregnant individuals ages 5 to 49 years, including healthcare workers (except those who care for severely immunocompromised patients in special care units) and individuals caring for children younger than six months.
There are risks associated with all vaccines, including FluMist. FluMist does not protect 100-percent of individuals vaccinated, or may not protect against viral strains not represented in the vaccine. FluMist is contraindicated in persons with hypersensitivity to any component of the vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a history of Guillain-Barre syndrome; and in individuals with known or suspected immune deficiency. The safety and efficacy of FluMist have not been established in pregnant women or for patients with chronic underlying medical conditions, including asthma or reactive airways disease; the vaccine should not be administered to these patients. See Prescribing Information for indications and usage, dosage and administration and safety information.