Published online February 1, 2005
PEDIATRICS Vol. 115 No. 2 February 2005, pp. 461-467 (doi:10.1542/10.1542/peds.2004-1891)
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Compliance With National Immunization Guidelines for Children Younger Than 2 Years, 1996-1999

Loren K. Mell, MD*,{ddagger}, David S. Ogren, MD{ddagger},§, Robert L. Davis, MD, MPH||, John P. Mullooly, PhD#, Steven B. Black, MD, Henry R. Shinefield, MD, Kenneth M. Zangwill, MD**, Joel I. Ward, MD**, S. Michael Marcy, MD{ddagger}{ddagger}, Robert T. Chen, MD, MA§§ for the Centers for Disease Control and Prevention Vaccine Safety Datalink Project

* Center for Health Studies, Group Health Cooperative, Seattle, Washington
{ddagger} Pritzker School of Medicine, University of Chicago, Chicago, Illinois
§ Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin
|| Departments of Pediatrics and Epidemiology, University of Washington, Seattle, Washington
Division of Research, Kaiser Permanente of Northern California, Oakland, California
# Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon
** Center for Vaccine Research, Harbor–UCLA Medical Center, Torrance, California
{ddagger}{ddagger} Kaiser–UCLA Vaccine Research Group, Southern California Kaiser Permanente, Panorama City, California
§§ National Immunization Program, Vaccine Safety and Development Activity, Centers for Disease Control and Prevention, Atlanta, Georgia

Objectives. To evaluate compliance with national immunization guidelines among a large cohort of children cared for at health maintenance organizations (HMOs) and to examine effects on immunization status.

Methods. A cohort study of 176134 children born between January 1, 1994, and December 31, 1997, and monitored from birth to the second birthday was performed. Subjects belonged to the Vaccine Safety Datalink Project, a study of children enrolled in 1 of 4 HMOs. Children were continuously enrolled in a HMO for the first 2 years of life. Prevailing recommendations regarding optimal ages of immunization and intervals between doses were applied to define appropriate immunization timing and immunization status. Noncompliance was defined as having a missing or late immunization or an immunization error. Immunization errors included invalid immunizations (too early to be acceptable), extra immunizations (superfluous immunizations or make-up immunizations for invalid immunizations), and missed opportunities resulting in late or missing immunizations.

Results. Although 75.4% of children in these HMOs were up to date for all immunizations at 2 years, only 35.6% of children were fully compliant with recommended immunization practices. Less than 8% of children received all immunizations in accordance with strict interpretation of recommended guidelines. Fifty-one percent of children had at least 1 immunization error by age 2 years; 29.7% had a missed opportunity with subsequent late or missing immunization, 20.4% had an invalid immunization, and 11.6% had an extra immunization. Common reasons for noncompliance included missed opportunities for the fourth Haemophilus influenzae type b vaccine (14.6%), invalid fourth diphtheria-tetanus-pertussis/acellular pertussis immunizations (11.0%), and superfluous polio immunizations (9.8%).

Conclusions. Approximately 35.6% of children were compliant with prevailing childhood immunization recommendations from 1996 to 1999. Efforts to improve compliance with guidelines are recommended, to optimize childhood infectious disease prevention.


Key Words: compliance • immunization • guidelines • health maintenance organization

Abbreviations: HMO, health maintenance organization • Hib, Haemophilus influenzae type b • DTP, diphtheria-tetanus-pertussis • DTaP, diphtheria-tetanus-acellular pertussis • HBV, hepatitis B virus • IPV, inactivated polio vaccine • OPV, oral polio vaccine • MMR, measles-mumps-rubella • VSD, Vaccine Safety Datalink • Hib-OMP, H influenzae type b meningococcal outer membrane protein conjugate vaccine • CI, confidence interval


Accepted Oct 27, 2004.


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