MedImmune says phase 3 data shows refrigerator-stable FluMist more effective than injectable vaccine

By E. Janene Geiss

Philadelphia, Dec. 12 - MedImmune, Inc. announced Monday that preliminary data from a phase 3 study indicating that CAIV-T (cold-adapted influenza vaccine, trivalent) showed a 55% significant reduction in influenza illness caused by any influenza strain compared to the injectable influenza vaccine (TIV).

The influenza attack rate was 8.6% for study participants receiving TIV compared to 3.9% for those who received CAIV-T, according to a company news release.

CAIV-T is MedImmune's investigational, refrigerator-stable formulation of FluMist (Influenza Vaccine Live, Intranasal), a frozen vaccine currently approved to prevent influenza in healthy children and adolescents, five to 17 years of age, and healthy adults, 18 to 49 years of age.

"This pivotal trial is the third phase 3 trial of CAIV-T to show statistically significant reductions in influenza disease compared to the injectible influenza vaccine. Collectively, these data suggest better efficacy against matched and mismatched strains and against both A and B strains," David M. Mott, president and chief executive officer, said in the release.

"Our objective now is to complete our analyses and prepare the data for submission, for which we will request priority review designation to the U.S. Food & Drug Administration in the second quarter of 2006. If approved by the FDA, we hope to have the opportunity to offer CAIV-T as an alternative to the injectable influenza vaccine beginning in the 2007 influenza season," Mott said.

The trial was a randomized, double-blind study designed to assess the safety and relative efficacy of CAIV-T and TIV in children ages six months through 59 months during the 2004-2005 influenza season.

The primary endpoint was culture confirmed influenza-like illness caused by wild type strains antigenically matched to the vaccine. CAIV-T showed a 44% reduction in the number of these cases, compared to TIV, officials said.

The trial also met its secondary efficacy endpoints, with CAIV-T showing a 58% reduction in modified influenza-like illness caused by antigenically mismatched wild type strains.

The study enrolled 8,492 children and was conducted at 249 sites in 16 countries in North America, Europe and Asia. The rates of serious adverse events and adverse events were similar in the two groups.

Two previously completed phase 3 studies have been conducted comparing CAIV-T to TIV, and MedImmune recently completed a study evaluating the safety and immunogenicity of FluMist when given concurrently with measles-mumps-rubella (MMR) and varicella vaccines in 1,245 healthy children ages 12 months through 15 months.

In September, MedImmune submitted a supplemental Biologics License Application with the FDA for approval to use CAIV-T in preventing influenza in healthy individuals 5 to 49 years of age. Included in the application were data from a recently completed pivotal phase 3 study comparing the immunogenicity of FluMist and CAIV-T, as well as additional preclinical and clinical data supporting the comparability of the two formulations, officials said.

MedImmune also said recently that it is working with the National Institutes of Health under a cooperative research and development agreement to produce and test attenuated, live intranasal influenza vaccines against pandemic influenza strains.

MedImmune is a Gaithersburg, Md., biotechnology company focused on development, manufacturing and commercialization of products to treat or prevent infectious diseases, immune system disorders and cancer.

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