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, Vaccines for Virus Diseases, GlaxoSmithKline Biologicals. "If the candidate vaccine is approved, infants could complete the rotavirus vaccine series by four months of age."
The CDC Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that infants receive routine vaccination with the vaccine currently licensed by the FDA at two, four, and six months of age in order to prevent rotavirus gastroenteritis.
About the Rotarix(R) Co-Administration Study
This Phase III study was conducted to confirm that two doses of the rotavirus candidate vaccine do not impair the immune response to routine infant vaccines currently used in the U.S. In the study, 484 healthy infants ranging from six to 12 weeks of age were randomized (1:1) into two groups. One group received three doses of the currently recommended infant vaccines, Pediarix(R) (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine), Prevnar(R) (Pneumococcal 7-valent Conjugate Vaccine) and ActHIB(R) (Haemophilus b Conjugate Vaccine), at two, four, and six months of age with the rotavirus candidate vaccine co-administered at two and four months of age (n=249). The second group received the rotavirus candidate vaccine administered separately at three and five months of age (n=235) as well as three doses of the currently recommended infant vaccines at two, four and six months of age.
Serum antibodies were measured one month after the third dose of routine vaccines (Pediarix, Prevnar and ActHIB). Antibody responses to routine vaccines were similar in both groups, indicating that the rotavirus candidate vaccine can be co-administered with other routine vaccinations without interfering with the immune response to any of the administered vaccines.
Results from the active phase of this study were included in GSK's Biologics License Application (BLA) for the rotavirus candidate vaccine, which was recently accepted for review by the FDA.
The GSK rotavirus candidate vaccine is a live-attenuated oral rotavirus vaccine licensed in 99 countries around the world. The vaccine is designed to prevent rotavirus gastroenteritis by mimicking natural rotavirus infection. Studies have shown that natural rotavirus infection provides significant protection from moderate to severe disease, regardless of rotavirus strain. In the BLA currently under review by the FDA, it is proposed that the vaccine would be given in two oral doses beginning at six weeks of age and completed by 24 weeks of age, with a minimum four-week interval between the doses. If approved, the vaccine could be integrated into the two and four month immunization visits.
Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe acute gastroenteritis in infants and young children in the U.S. and worldwide. Severe diarrhea and dehydration occurs from as young as three months of age.
In the U.S. each year, 2.7 million children younger than five years of age suffer from rotavirus disease, resulting in 410,000 clinic visits and up to 272,000 emergency room visits. In addition, between 55,000 and 70,000 children are hospitalized each year and 20-60 die.
GlaxoSmithKline: A Leader in Vaccines
GlaxoSmithKline, with U.S. operations in Philadelphia, PA, and Research Triangle Park, NC, is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Biologicals (GSK Bio), one of the world's leading vaccine manufacturers, is headquartered in Rixensart, Belgium, where the majority of GlaxoSmithKline's activities in the field of vaccine research, development and production are conducted.
GSK Bio employs more than 1,500 scientists, who are devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide. In 2006, GSK Bio distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and the developing world - an average of 3 million doses a day. Of those vaccine doses, approximately 136 million were doses of combination pediatric vaccines which protect the world's children from up to six diseases in one vaccine.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this Announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2006.
Prevnar(R) is a registered trademark of Wyeth Pharmaceuticals.
ActHib(R) is a registered trademark of sanofi pasteur, the vaccines business of sanofi-aventis Group.
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1 Abu-Elyazeed R, et al. Co-Administration of RIX4414 Oral Human Rotavirus Vaccine, does not Impact the Immune response to Antigens Contained in Routine Infant Vaccines in the United States.
2 Centers for Disease Control and Prevention. Prevention of Rotavirus Gastroenteritis Among Infants and Children. MMWR. 2006; 55(RR12); 1-13. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5512a1.htm
3 Green KY, et al. Homotypic and Heterotypic Epitope-Specific Antibody Responses in Adult and Infant Rotavirus Vaccines: Implications for Vaccine Development. The Journal of Infectious Diseases. 1990;161:667-679.
4 Centers for Disease Control and Prevention. Recommended Immunization Schedule for Ages 0-6 Years - United States 2007. Available at (please copy- paste into your browser): http://www.cdc.gov/vaccines/recs/schedules/downloads/child/2007/child- schedule-bw-print.pdf
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