This press release is intended for business journalists and analysts/investors. Please note that this release may not have been issued in every market in which GSK operates.

Phase III study results show candidate combination vaccine KINRIX is immunogenic and well-tolerated

Data published in Pediatric Infectious Disease Journal show investigational DTaP-IPV combination vaccine can offer protection in 4 to 6 year-olds with one less shot

Philadelphia, PA (March 27, 2008) – Results from a U.S. Phase III clinical study of KINRIX™, GlaxoSmithKline’s candidate DTaP-IPV (diphtheria, tetanus, acellular pertussis - inactivated poliovirus) combination vaccine, have been published in the April 2008 issue of the Pediatric Infectious Disease Journal.   In this study, KINRIX demonstrated immune response and a safety profile that was comparable to separately administered DTaP and IPV vaccines.  If approved, KINRIX would be the first combination vaccine to offer protection against four serious diseases (diphtheria, tetanus, pertussis and polio) in one shot for children 4 to 6 years of age in the U.S. 

The randomized, multi-center Phase III clinical trial involved over 4,000, 4 to 6 year old children and evaluated the immune response and safety profile of KINRIX in children receiving this combination (N=3,156) as compared to separately administered DTaP (INFANRIX^®) and IPV (IPOL^®) vaccines (N=1,053), when co-administered with measles, mumps and rubella (MMR) vaccine (M-M-R^®_II) at a separate site.  The data show that the immune response to KINRIX was comparable to the response separately administered DTaP and IPV vaccines with respect to DTaP antigen booster response rates and poliovirus antibody geometric mean titer (GMT) ratios.

“The results of this Phase III clinical trial show that KINRIX, if approved, would offer protection similar to the DTaP and IPV vaccines that are given separately, and it has a comparable safety profile,”said Steven Black, M.D., Professor of Pediatrics, Center for Global Child Health, Cincinnati Children’s Hospital.  “The advantage of Kinrix is that it combines two shots into one, and could mean one less shot for 4 to 6 year-olds.”

According to the Centers for Disease Control and Prevention’s (CDC’s)-recommended immunization schedule, 4 to 6 year-olds may receive five or more vaccinations in a single visit. Currently, the 4 to 6 year-old DTaP and IPV vaccinations are given as two separately administered shots.  If approved, KINRIX would reduce the total number of shots preschoolers and kindergarteners need to get, to meet CDC recommendations.

GlaxoSmithKline’s candidate DTaP-IPV combination vaccine, KINRIX, is under review with the U.S. Food and Drug Administration (FDA).  The data from this clinical trial was included by GlaxoSmithKline as part of the Biologics License Application (BLA) filed with the FDA.

About the Study

Study participants were distributed into two groups.  The combination group (N=3,156 – consisting of three groups who received three different lots of DTaP-IPV pooled together) was made up of those children who received the DTaP-IPV vaccine co-administered with MMR vaccine at separate sites.  The component group (N=1,053) was made up of those infants who received separately administered DTaP and IPV vaccines co-administered with MMR vaccine at separate sites.  A subset of the children (N=1,331) had serological testing to evaluate the immunogenicity of the DTaP-IPV vaccine.

Study results showed that children receiving the combination vaccine demonstrated overall a comparable immunogenicity and safety profile to children receiving the separately administered component vaccines.  More specifically:

• One month following vaccination, all subjects in both treatment groups had seroprotective levels of anti-D and anti-T (≥0.1 IU/mL), and anti-poliovirus types 2 and 3 (titer ≥1:8), and all but one subject (in the DTaP-IPV group) had seroprotective levels of anti-poliovirus type 1 antibody.  At least 99.8 percent of subjects in both groups were seropositive for antibodies to pertussis antigens.
• The booster response rate for one or more DTaP antigens was at least 92.2% in the Kinrix recipients and 92.6% in the separately administered Infanrix and IPOL vaccines recipients.
• The booster response rate for one or more poliovirus antigens was at least 96.6% in the Kinrix recipients and 92.8% in the separately administered Infanrix and IPOL vaccines recipients.
• All pre-specified immunogenicity and safety non-inferiority criteria were achieved.
• Overall reported incidence of local and systemic adverse events were comparable in both study groups.

 

The most frequently reported solicited local reaction (>50%) was injection site pain.  Other common solicited local reactions (≥25%) were redness, increase in arm circumference, and swelling.  Common solicited general adverse events (≥15%) were drowsiness, fever (≥99.5ºF), and loss of appetite. 

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.

GlaxoSmithKline Biologicals (GSK Biologicals) is a global vaccine company which has shown to be a leader in innovation.  The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development.  Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2007 GSK Biologicals distributed 1.1 billion doses of vaccines to 169 countries in both developed and the developing world – an average of 3 million doses a day.

GSK Biologicals employs over 9 000 people worldwide including more than 1,600 passionate scientists engaged in research aimed at discovering innovative vaccines that contribute to the health and well-being of people of all generations around the world.

KINRIX, INFANRIX, and PEDIARIX are trademarks of the GlaxoSmithKline group of companies.

###

IPOLis a registered trademark of Sanofi Pasteur, the vaccines business of sanofi-aventis Group.

M-M-R_II is a registered trademark of Merck & Co., Inc.

Inquiries:

 US Media Inquiries
Jennifer Armstrong
+1 919 483 2839