- Company Also Completes Patient Enrollment in Bridging Study Comparing
Refrigerator-Stable Formulation With Currently Marketed Frozen FluMist(R) -
- New Studies are Pivotal Part of Broad Plan for Intranasal
Influenza Vaccine Technology -
GAITHERSBURG, Md., Oct. 20 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that it has initiated a pivotal head-to-head
Phase 3 clinical trial designed to compare its next-generation, refrigerator-
stable intranasal influenza vaccine (CAIV-T: cold adapted intranasal influenza
vaccine, trivalent) with the injectable flu shot (TIV: trivalent influenza
The company also announced that it has completed enrollment in a bridging
study designed to establish that CAIV-T, the refrigerator-stable form of its
live, attenuated intranasal influenza technology, is equivalent to its
currently marketed frozen formulation, FluMist (Influenza Virus Vaccine Live,
"With the advancement of these studies, we remain on course with our
influenza vaccine development program," said Edward M. Connor, M.D., executive
vice president of clinical development and chief medical officer at MedImmune,
Inc. "These trials will provide pivotal data regarding the safety and
relative efficacy of our intranasal vaccine compared to TIV, as well as data
regarding the comparative safety and immune responses for the frozen and the
refrigerator-stable formulations of FluMist. MedImmune remains hopeful that
it will deliver an improved option for the prevention of influenza disease,
particularly for children."
Phase 3 Head-to-Head Study
The Phase 3 head-to-head trial is a randomized, double-blind study that
will compare the safety and relative efficacy of CAIV-T to TIV during the
2004/2005 influenza season. The study will be conducted at approximately 300
sites in the Northern Hemisphere. Approximately 7,000 children across 18
countries between the ages of 6 months through 59 months will be randomized
one-to-one in this study to receive either CAIV-T or TIV. All participants
will receive both an intranasal mist and an intramuscular injection to
preserve the double-blind design of the study.
MedImmune's bridging study is a double-blind, randomized trial designed to
establish the equivalent immunogenicity and safety of MedImmune's two live,
attenuated intranasal formulations (refrigerator-stable and frozen). The
study is being conducted at 31 sites in the United States. In this study, 977
healthy participants between the ages of 5 and 49 years have been randomized
one-to-one to receive either CAIV-T or FluMist. Participants 5 through 8
years of age will receive two doses of study vaccine, while those 9 through 49
years of age have received one dose of study vaccine.
Additional CAIV-T Studies
To date, the safety, tolerability and efficacy of CAIV-T has been studied
in a number of trials involving populations between the ages of 6 weeks and 98
years, including healthy persons and persons at high-risk of complications due
to influenza. Data from several of these trials showing that the vaccine was
safe and effective in reducing the incidence of community acquired influenza
in the populations studied were presented in October 2003 at the Fifth Annual
Options for the Control of Influenza Conference. Further, data from two Phase
3 trials involving a total of 4,400 children with a history of respiratory
illness or asthma were presented in May 2004 at the Pediatric Academic
Societies' annual meeting, showing that CAIV-T provided superior protection
with a similar safety profile to the injectable flu vaccine.
Post-Marketing and Additional Safety Studies with FluMist
To collect additional safety and efficacy on its currently marketed live,
attenuated intranasal influenza vaccine, MedImmune is advancing a Phase 1
placebo-controlled trial in 20 immunocompromised children with cancer, as well
as a Phase 1/2 trial comparing FluMist to TIV in 300 HIV-infected children.
The HIV trial is being conducted in collaboration with the Pediatrics AIDS
Clinical Trials Group (PACTG).
A number of post-marketing studies for FluMist are also underway,
including: several trials in elementary schools in Washington, Texas, Maryland
and Minnesota to determine the direct and indirect impact of FluMist
immunization among school-aged children and their families; a Phase 4, open-
label, single-arm trial to assess the shedding, immunogenicity and safety of
FluMist in healthy individuals 5 to 49 years of age; a large safety
surveillance trial that will enroll at least 60,000 individuals between 5 and
49 years of age over multiple influenza seasons at participating Kaiser
Permanente centers in Northern California and Colorado; and a community-based,
non-randomized, open-label trial to assess safety and herd immunity in
approximately 5,000 healthy children between 5 and 17 years of age in Central
In a typical year, influenza is responsible for an average of 36,000
deaths (primarily in the elderly) and 200,000 hospitalizations in the United
States. Children have the highest rates of influenza infection of any age
group during the flu season and are important disseminators of the influenza
virus into communities. According to the Centers for Disease Control and
Prevention (CDC), 152 children younger than 18 years of age died in the United
States from influenza and its complications during the 2003-2004 flu season.
Seventy-one percent of these children had no high-risk medical conditions, as
defined by the CDC. Influenza vaccination of all healthy children 6-23 months
of age and their close contacts is now routinely recommended by the CDC's
Advisory Committee on Immunization Practices.
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.
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.
MedImmune's Commitment to Innovation
FluMist represents the first new influenza vaccine introduced to the U.S.
since 1945. It is also the first nasally administered vaccine for any disease
approved by the U.S. Food and Drug Administration. Nearly $1 billion has been
invested to date to bring to market the first new innovation in flu prevention
in nearly 60 years. Twenty-one clinical trials involving more than 30,000
subjects have already been completed for FluMist. Twenty-one additional
trials involving an additional 34,000 subjects have already been completed for
the next-generation, refrigerator-stable formulation of FluMist, known as
CAIV-T. MedImmune currently has an additional eight clinical trials involving
more than 70,000 subjects underway for FluMist and CAIV-T.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value to
shareholders. Dedicated to advancing science and medicine to help people live
better lives, the company is focused on the areas of pediatric infectious
diseases, cancer and inflammatory diseases. With approximately 1,900
employees worldwide, MedImmune is headquartered in Maryland. For more
information, visit the company's website at http://www.medimmune.com.
This announcement may contain, in addition to historical information,
certain forward-looking statements that involve risks and uncertainties. Such
statements reflect management's current views and are based on certain
assumptions. Actual results could differ materially from those currently
anticipated as a result of a number of factors, including risks and
uncertainties discussed in MedImmune's filings with the U.S. Securities and
Exchange Commission. The company is developing several products for potential
future marketing. There can be no assurance that such development efforts
will succeed, that such products will receive required regulatory clearance or
that, even if such regulatory clearance is received, such products will
ultimately achieve commercial success.
SOURCE MedImmune, Inc.
/CONTACT: Media: Jamie Lacey, +1-301-398-4035, or Investors: Peter Vozzo,
+1-301-398-4358, or John Filler, +1-301-398-4086, all of MedImmune, Inc./
/Web site: http://www.medimmune.com /
CO: MedImmune, Inc.
IN: MTC HEA BIO
-- DCW063 --
7567 10/20/2004 14:12 EDT http://www.prnewswire.com