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New Data Show That GlaxoSmithKline's Rotarix(R) Could Be Given With Other Routine Infant Vaccines in the U.S.
Date:9/19/2007

If Approved by FDA, Rotavirus Candidate Vaccine Could Be Integrated Into the Current Two and Four Month Infant Immunization Schedule in the U.S.

CHICAGO, Sept. 19 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced new study results today that indicate that Rotarix(R), an oral candidate vaccine for infants to prevent rotavirus gastroenteritis, could be co-administered with routine infant vaccines recommended in the U.S. at the two and four month old immunization visits, if approved by the U.S. Food and Drug Administration (FDA).

The data show that co-administration of GSK's rotavirus candidate vaccine does not impair the immune responses to vaccines currently included in the Centers for Disease Control and Prevention's (CDC) schedule of recommended immunizations for infants. These data are results from a Phase III clinical trial presented today at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago, Illinois.

Severe, dehydrating gastroenteritis occurs primarily among children aged three to 35 months. Of children hospitalized with rotavirus, approximately 17 percent are younger than six months old. The candidate vaccine contains a live, weakened form of natural human rotavirus derived from the most common human rotavirus strain. Published data show that immunity resulting from natural human rotavirus infection provides significant protection against moderate to severe disease, regardless of rotavirus strain.

"These co-administration data indicate that GSK's rotavirus candidate vaccine could be integrated into the current infant immunization schedule in the U.S.," said Remon Abu-Elyazeed, M.D., Ph.D., Director, Clinical Development, Vacc
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SOURCE GlaxoSmithKline
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