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GAITHERSBURG, Md. -- MedImmune, Inc.
announced today that it has completed enrolling nearly 8,500
children in a pivotal Phase 3 trial approximately one week after initiating
the study. The trial is designed to compare the next-generation,
refrigerator-stable intranasal influenza vaccine, known as CAIV-T (cold
adapted intranasal influenza vaccine, trivalent), to the injectable influenza
vaccine. MedImmune is developing CAIV-T as a potential improvement over its
currently marketed frozen influenza vaccine, FluMist (Influenza Virus Vaccine
MedImmune also announced today that it has begun enrolling
patients in a Phase 1/2 study comparing the safety and efficacy of FluMist to
the injectable influenza vaccine in children infected with HIV.
"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."
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 21 trials involving
approximately another 34,000 subjects have already been completed for CAIV-T.
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
Source: MedImmune, Inc.