Data shows use of a combination vaccine increased on-time immunization rates in infants

April 07, 2006

Seattle, WA - Results from a retrospective observational study of data among members of a managed care health plan in Utah showed that infants who received a combination vaccine had significantly higher rates of receiving all of their vaccinations on-time in the first two years of life compared to infants given separate component vaccines. Results from the study were presented today at the Academy of Managed Care Pharmacy's (AMCP) 18th Annual Conference in Seattle, WA, by Laura Happe, Pharm.D., M.P.H., associate director at Applied Health Outcomes, a research strategy company in Palm Harbor, FL. This study was conducted by Applied Health Outcomes.

"While immunization rates in the United States are at an all time high, the 2003 National Immunization Survey showed that only 26 percent of infants receive their vaccinations on-time according to the ACIP recommended childhood schedule," said Dr. Happe. "Delayed immunizations may put children at risk for vaccine-preventable diseases and contribute to failure to complete the vaccination schedule. Combination vaccines may increase the number of infants who receive their vaccinations on-time."

The study evaluated the immunization history using claims and registry data of infants born between January 2003 and October 2003 with continuous enrollment in Intermountain Healthcare Health Plans, Incorporated, an integrated nonprofit health plan. Infants who were eligible for the study were distributed into two matched cohorts: the combination group (n=1,135) was made up of those who received at least one dose of PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed (DTaP), Hepatitis B (Recombinant, HepB) and Inactivated Poliovirus Vaccine (IPV) Combined]; and the component group (n=1,913) was made up of those who were not immunized with combination DTaP-HepB-IPV. Timeliness was calculated as a percentage of children who received the immunization series of interest within the timeframe recommended by the ACIP/AAP/AAFP immunization schedule.

Results from the analysis showed that the combination cohort had significantly more children who received their vaccinations on-time compared to the component group for HEDIS Combo 2 series (includes 4 doses of DTaP, 3 doses of polio, 1 dose of MMR, 3 doses of hepatitis B, 3 doses of Hib, and 1 dose of varicella vaccine) (42.7 percent vs. 34.9 percent; p<0.001). On-time rates were also significantly higher in the combination cohort compared to the component cohort for the following immunization series: 3 doses of hepatitis B vaccine (90.4 percent vs. 77.9 percent; p<0.001); 3 doses of polio (IPV) vaccine (86.9 percent vs. 78.2 percent; p<0.001); 3 or 4 doses of Haemophilus influenzae type b (Hib) vaccine (56.3 percent vs. 49.2 percent; p<0.001); and 1 dose of measles, mumps and rubella vaccine (MMR) vaccine (88.5 percent vs. 85.4 percent; p=0.020).

"Coverage rates are widely recognized as a quality indicator; however, timeliness of childhood vaccinations may have important implications in reducing the risk of vaccine-preventable disease," continued Dr. Happe. "These results suggest that expanding the number of infants who receive combination vaccines may increase the number of infants who receive their vaccinations on-time."
GlaxoSmithKline provided financial support for this observational study.

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 as a three-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age. PEDIARIX should not be administered to any infant before the age of 6 weeks or to individuals 7 years of age or older. PEDIARIX has been marketed in the United States since 2003. PEDIARIX has been evaluated in numerous clinical trials, where 20,739 doses of PEDIARIX were administered to 7,028 infants. In clinical studies, adverse events in infants receiving PEDIARIX included injection-site reactions (pain, redness, or swelling), fever, and fussiness. Administration of PEDIARIX was associated with higher rates of fever relative to separately administered vaccines (see Adverse Reactions section of the package insert). PEDIARIX is contraindicated in infants with known hypersensitivity to any component of the vaccine including yeast, neomycin, and polymyxin-B. As with any vaccine, vaccination with PEDIARIX may not protect 100% of susceptible individuals.

PEDIARIX is manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium and distributed by GlaxoSmithKline.

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.

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