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GlaxoSmithKline’s investigational DTaP-IPV combination vaccine shown to be immunogenic and well-tolerated in Phase III clinical trial


WEBWIRE

GlaxoSmithKline (GSK) today announced results from a U.S. phase III vaccine clinical study presented this week at the Pediatric Academic Societies’ (PAS) Annual Meeting in Toronto, Canada. The study evaluated the immune response and safety profile of the investigational combination DTaP-IPV (diphtheria, tetanus, acellular pertussis - inactivated poliovirus) vaccine in children ages 4 to 6 years-old as compared to separately administered DTaP (INFANRIX®) and IPV (IPOL®) vaccines, when co-administered with measles, mumps and rubella (MMR) vaccine (M-M-RII®) at a separate site. 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.

The investigational DTaP-IPV vaccine has not been approved for use in the United States.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP) recommend that children receive booster shots to protect against diphtheria, tetanus and pertussis (DTaP) and polio (IPV) at the 4 to 6 year-old doctor visit. Most states in the U.S. require either a fifth dose of DTaP vaccine and/or a fourth dose of IPV vaccine for kindergarten school entry. Separately administered DTaP and IPV vaccines are currently used to complete these recommended immunizations.

“An increasing number of vaccines are being recommended to prevent childhood diseases, including additional vaccines at the 4 to 6 year-old doctor’s visit,” said Barbara Howe, MD, Vice President, North American Vaccine Development, GlaxoSmithKline. “We are pleased to be developing a new combination vaccine that if approved, could offer one potential solution to the problem of increased number of injections during single doctor visits.”

DTaP-IPV Study Results
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 plus MMR vaccines. The component group (N=1,053) was made up of those infants who received separately administered DTaP and IPV vaccines plus MMR vaccine. A subset of the children (N=1,331) had serological testing to evaluate the immunogenicity of 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:
• Booster response was seen in at least 92.2 percent and 92.6 percent of children in the DTaP-IPV and INFANRIX plus IPOL groups, respectively, for each DTaP antigen.
• All subjects in both treatment groups had seroprotective levels of anti-D, anti-T, and anti-poliovirus types 2 and 3 antibodies; all but 1 subject (in the DTaP-IPV group) had seroprotective anti-poliovirus type 1 levels. At least 99.8 percent of subjects in both groups were seropositive for antibodies to pertussis agents.
• All pre-specified immunogenicity and safety non-inferiority criteria were achieved.
• Overall reported adverse events – including swelling at the DTaP-based injection site – were comparable in both study groups.

The most commonly reported solicited adverse event (AE) was pain at the DTaP-based injection site: reported by 57 percent of the children who received the investigational DTaP-IPV vaccine and 53 percent of the children who received the separately administered DTaP vaccine. This difference was statistically significant. Redness at the DTaP-based injection site was reported by 37 percent of the children who received the investigational DTaP-IPV vaccine and 37 percent of the children who received the separately administered DTaP vaccine; and swelling at the DTaP-based injection site was reported by 26 percent of the children who received the investigational DTaP-IPV vaccine and 27 percent of the children who received the separately administered DTaP vaccine.

The most commonly reported solicited general AE was drowsiness reported by 19 percent of the children who received the investigational DTaP-IPV vaccine and 18 percent of the children who received the separately administered DTaP and IPV vaccines. In addition, incidence of swelling with increased upper arm circumference at the DTaP-based injection site was 0.6 percent in the investigational DTaP-IPV vaccine group and one percent in the separately administered DTaP and IPV vaccines group.

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.



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