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CDC Immunization Advisory Committee Recommends Two New Pediatric Vaccines from GlaxoSmithKline

ATLANTA and PHILADELPHIA, June 26 /PRNewswire-FirstCall/ --

Highlights Include:

-- GSK's ROTARIX(R) [Rotavirus Vaccine, Live, Oral] recommended for routine vaccination of infants to protect against rotavirus gastroenteritis (RGE)

-- ROTARIX, approved by the FDA on April 3, 2008, is the only rotavirus vaccine that offers completion of rotavirus immunization by four months of age in just two oral doses

-- GSK's KINRIX(TM) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine] recommended for vaccination of children to protect against diphtheria, tetanus, pertussis and polio diseases

-- KINRIX was approved by the FDA on June 24, 2008 to offer protection against four serious diseases (diphtheria, tetanus, pertussis and polio) in one shot for eligible 4 to 6 year-olds

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) voted to include the company's two newest pediatric vaccines, ROTARIX(R) [Rotavirus Vaccine, Live, Oral] and KINRIX(TM) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine], in the childhood immunization program. ROTARIX is a two-dose oral rotavirus vaccine for infants and KINRIX is a combination vaccine that protects children against four diseases (diphtheria, tetanus, pertussis and polio) in one shot. These vaccines are additions to GSK's expanding U.S. vaccines portfolio, which includes some of the most widely used immunizations for serious vaccine-preventable diseases in infants, adolescents and adults.

"The advisory committee's recommendations for ROTARIX and KINRIX are important milestones that reinforce GSK's commitment to developing innovative, effective vaccines that can be easily added to the current childhood immunization schedule," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "In 2003, GSK introduced the first combination vaccine to protect infants against five diseases in only one shot. These recommendations affirm that GSK continues to develop vaccines that can play a crucial role in public health."

The CDC's ACIP recommended that ROTARIX be routinely given to infants to protect against rotavirus gastroenteritis (RGE). ROTARIX is the only rotavirus vaccine to allow for completion of the rotavirus series by four months of age with just two oral doses. In addition, the ACIP recommended that KINRIX may be given to children 4 to 6 years-old as the fifth dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) and the fourth dose of Inactivated Poliovirus (IPV).

KINRIX is the first approved combination vaccine to offer protection against all of these diseases in one shot for eligible 4 to 6 year olds. Children this age may need five or more vaccinations in a single office visit. By combining two vaccinations into one shot, KINRIX can help ease the vaccination process for children, parents and vaccinators. The ACIP also voted to include ROTARIX and KINRIX in the U.S. federal government's Vaccines for Children (VFC) program.

ROTARIX Offers Protection Against the Most Commonly Circulating Rotavirus Types

ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered orally as a two-dose series in infants and children. ROTARIX was developed to mimic natural infection and to protect against rotavirus gastroenteritis without regard to serotype. Studies have shown that naturally occurring rotavirus infection protects against subsequent moderate to severe rotavirus gastroenteritis regardless of the infecting serotype(s).

Rotavirus infects virtually every child worldwide by age five and is the leading cause of severe gastroenteritis in infants and young children in the U.S. and worldwide. Severe, dehydrating gastroenteritis can occur as young as three months of age.

Clinical data published on two oral doses of ROTARIX show that protection was sustained through the first two years of life and ROTARIX was highly efficacious against rotavirus hospitalizations (96%) and severe rotavirus gastroenteritis (90%). Additionally, in a European phase III study, 90 percent efficacy against RGE of any severity was observed immediately following dose one and prior to the second dose. The protection offered by the two-dose schedule of ROTARIX, observed as early as after dose one, is particularly relevant as severe dehydrating rotavirus gastroenteritis can occur as young as three months of age.

In clinical studies, ROTARIX demonstrated significant and sustained efficacy through two rotavirus seasons against severe rotavirus gastroenteritis caused by types G1 (96%), G2 (86%), G3 (94%), G4 (95%), and G9 (85%), the most common circulating rotavirus types in the U.S.

ROTARIX is licensed in more than 100 countries around the world. More than 25 million doses of ROTARIX have been distributed worldwide. The U.S. FDA's approval of ROTARIX was based on one of the largest clinical development plans undertaken by a vaccine manufacturer and includes data from nearly 75,000 infants.

In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting. History of uncorrected congenital malformation of the gastrointestinal tract is a contraindication. Previous hypersensitivity to any component of ROTARIX, including latex rubber, should be reviewed prior to administration. Administration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness in infants with chronic gastrointestinal disorders, or with known primary or secondary immunodeficiencies, have not been evaluated. More information about ROTARIX is available at

KINRIX Offers Protection Against Four Serious Diseases in One Shot

KINRIX is approved for children 4 to 6 years of age whose previous DTaP vaccinations have been with PEDIARIX(R) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] and/or INFANRIX(R) [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed] to protect against diphtheria, tetanus, pertussis and polio diseases.

Health experts recommend combination vaccines to reduce the number of shots children receive in a single doctor visit. In fact, combination vaccines, such as DTP [diphtheria, tetanus and pertussis], have been available and effectively used for almost 60 years.

Clinical studies of KINRIX have demonstrated that this new combination vaccine offers similar protection to the separately administered Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) and Inactivated Poliovirus (IPV) vaccines, with a comparable safety profile. These results were confirmed in the pivotal Phase III trial of KINRIX, which was a randomized, controlled study conducted in the U.S. in which 3,156 children 4 to 6 years of age were vaccinated with KINRIX. All children studied had previously received four doses of DTaP (INFANRIX) and three doses of IPV (IPOL(R)). All children in the study also received the second dose of U.S. licensed measles, mumps and rubella (MMR) vaccine (M-M-RII(R)) at the same time.

In clinical studies, common adverse events were injection-site reactions (pain, redness, swelling, or increase in arm circumference), drowsiness, fever, and loss of appetite. Previous hypersensitivity to any component of KINRIX, including neomycin and polymyxin B, is a contraindication. Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. The decision to give KINRIX should be based on potential benefits and risks, if Guillain-Barr syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events have occurred in temporal relation to receipt of a pertussis-containing vaccine. The needleless, prefilled syringes contain dry natural latex rubber and may cause allergic reactions. For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination. Vaccination with KINRIX may not protect all individuals who received the vaccine. More information on KINRIX is available at

GlaxoSmithKline: A Leader in Vaccines

GlaxoSmithKline Biologicals (GSK Biologicals) is a leading global vaccine manufacturer committed to preventing disease in people of all ages with innovative vaccines and delivery systems.

The division, headquartered in Belgium, is active in vaccine research, development and production with more than 30 vaccines currently available globally and 20 more in development. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines - an average of 3 million doses a day.

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit

ROTARIX, KINRIX, PEDIARIX and INFANRIX are all trademarks of the GlaxoSmithKline group of companies.
US Media Inquiries Jeff McLaughlin +1-919-483-2839

Jennifer Armstrong

SOURCE GlaxoSmithKline
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