Manual for the Surveillance of Vaccine-Preventable Diseases

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VPD Surveillance Manual Manual for the Surveillance of Vaccine-Preventable Diseases Edited by Sandra W. Roush, MT, MPH Linda M. Baldy, MPH National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention Department of Health and Human Services

VPD Surveillance Manual Manual for the Surveillance of Vaccine-Preventable Diseases Available on the internet at: http://www.cdc.gov/vaccines/pubs/surv-manual/ Suggested citation Centers for Disease Control and Prevention. Manual for the surveillance of vaccine-preventable diseases. Centers for Disease Control and Prevention, Atlanta, GA, 2012. This manual is not intended to be a therapeutic guide; therefore, while dosages of antimicrobials and immunobiologics are discussed in the context of prophylaxis and treatment for case-patients and contacts, physicians and other health-care professionals should review the package inserts prepared by the manufacturers to determine appropriate dosages. This manual is designed to provide general guidance regarding surveillance activities for vaccine-preventable diseases. Because recommendations for use of vaccines may change, readers should consult their local or state health departments or CDC s Vaccines website at http://www.cdc.gov/vaccines/. Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Public Health Service or the U.S. Department of Health and Human Services.

VPD Surveillance Manual Acknowledgments This manual was prepared by the Centers for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases. We thank colleagues in the National Center for Immunization and Respiratory Diseases, CDC, and others who offered advice, made specific recommendations on format and content, reviewed drafts, or assisted in other ways in the preparation of this manual. We particularly wish to acknowledge the valuable assistance of the following: Cathy Hogan Curt Wommack

VPD Surveillance Manual Table of Contents Introduction Acronyms Definition of Terms Chapter 1: Diphtheria Chapter 2: Haemophilus influenzae Type b Invasive Disease Chapter 3: Hepatitis A Chapter 4: Hepatitis B Chapter 5: Human Papillomavirus Chapter 6: Influenza Chapter 7: Measles Chapter 8: Meningococcal Disease Chapter 9: Mumps Chapter 10: Pertussis Chapter 11: Pneumococcal Disease Chapter 12: Polio (not available) Chapter 13: Rotavirus Chapter 14: Rubella Chapter 15: Congenital Rubella Syndrome Chapter 16: Tetanus Chapter 17: Varicella Chapter 18: Surveillance Indicators Chapter 19: Enhancing Surveillance Chapter 20: Analysis of Surveillance Data Chapter 21: Surveillance for Adverse Events Following Immunization Chapter 22: Laboratory Support for the Surveillance of Vaccine-Preventable Diseases Chapter 23: National Surveillance of Vaccine-Preventable Diseases Chapter 24: State-Specific Surveillance of Vaccine-Preventable Diseases Appendices

Introduction v Introduction This manual was first developed in 1996 to provide general guidance to state and local health department personnel who are involved in surveillance activities for vaccine-preventable diseases. This manual answers commonly asked questions regarding the surveillance and reporting of vaccine-preventable diseases and provides information on enhancing existing surveillance systems. Several reference documents, tables, and worksheets have been included in this manual for your convenience and information. The worksheets in this manual are in the public domain and may be copied and distributed for use in public health surveillance activities. Please forward any suggestions and comments regarding this manual to: Surveillance Officer National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention 1600 Clifton Road NE, MS-A27 Atlanta, GA 30333 Phone: 404-639-8741

Acronyms vi Acronyms ACIP APHL CDC CF CMV CPHA CRS CSF CSTE DAT DFA DHHS DRSP DT DTP DTaP EBV EIA ELISA ELR FAMA FDA HA HAV HBcAg HBIG HBeAg HBsAg HBV HCV HDV HI Hi Hib HMO IFA IG IOM Advisory Committee on Immunization Practices Association of Public Health Laboratories Centers for Disease Control and Prevention Complement fixation Cytomegalovirus Commission on Professional and Hospital Activities Congenital rubella syndrome Cerebrospinal fluid Council of State and Territorial Epidemiologists Diphtheria antitoxin Direct fluorescent antibody Department of Health and Human Services Drug-resistant Streptococcus pneumoniae Diphtheria and tetanus toxoids Diphtheria and tetanus toxoids and whole-cell pertussis vaccine Diphtheria and tetanus toxoids and acellular pertussis vaccine Epstein-Barr virus Enzyme-immunoassay Enzyme-linked immunosorbent assay Electronic laboratory reporting Fluorescent antibody to membrane antigen Food and Drug Administration Hemagglutinin Hepatitis A virus Hepatitis B core antigen Hepatitis B immune globulin Hepatitis B e antigen Hepatitis B surface antigen Hepatitis B virus Hepatitis C virus Hepatitis D virus Hemagglutination inhibition Haemophilus influenzae Haemophilus influenzae type b Health maintenance organization Indirect fluorescent antibody Immune globulin Institute of Medicine

Acronyms vii IPV Inactivated poliovirus vaccine LA Latex agglutination MMR Measles-mumps-rubella vaccine MMWR Morbidity and Mortality Weekly Report MR Measles-rubella vaccine MSAEFI Monitoring System for Adverse Events Following Immunization NA Neuraminidase NCCLS National Committee for Clinical Laboratory Standards NCHS National Center for Health Statistics NCIRD National Center for Immunization and Respiratory Diseases NCRSR National Congenital Rubella Syndrome Registry NCVIA National Childhood Vaccine Injury Act of 1986 NEDSS National Electronic Disease Surveillance System NETSS National Electronic Telecommunications System for Surveillance NHANES National Health and Nutrition Examination Survey NHIS National Health Interview Survey NNDSS National Notifiable Diseases Surveillance System NVICP National Vaccine Injury Compensation Program OPV Oral poliovirus vaccine P&I Pneumonia and influenza PCR Polymerase chain reaction PHA Passive hemagglutination RASH Rapid Surveillance Helper RET Reportable Events Table RIA Radioimmunoassay SIDS Sudden Infant Death Syndrome SHC State health coordinator SPSS Supplementary Pertussis Surveillance System TIG Tetanus immune globulin TT Tetanus toxoid VAE Vaccine adverse event VAERS Vaccine Adverse Event Reporting System VAPP Vaccine-associated paralytic poliomyelitis VHSP Viral Hepatitis Surveillance Program VPD Vaccine-preventable disease VZIG Varicella-zoster immune globulin VZV Varicella-zoster virus WBC White blood-cell count WHO World Health Organization

Definitions of Terms viii Definitions of Terms Attenuated virus Breakthrough Clinically compatible case Confirmed case Contraindication Encephalitis Epidemiologically linked case Erythema Exanthem Immunocompromised Incubation period Laboratory confirmed case Line listing Meets the clinical case definition Primary vaccine failure Probable case Secondary vaccine failure Sentinel event A strain of virus whose virulence has been lowered by physical or chemical processes or by repeated passage through the cells of another species. The appearance of clinical disease in an individual who has previously been vaccinated against the agent causing the disease. A case featuring a clinical syndrome generally compatible with the disease, but for which specific clinical criteria may not have been met unless they are noted in the case classification. A case that is classified as confirmed for reporting purposes. A characteristic or attribute of an individual that may be temporary or permanent that prohibits the administration of a drug, vaccine, or other therapeutic intervention. An inflammatory condition of brain tissue caused by a variety of infectious and non-infectious diseases. In varicella, influenza, and measles, this is sometimes referred to as post-infectious encephalitis. A case in which the patient has or has had contact with one or more persons who have or have had the disease, and transmission of the agent by the usual modes of transmission is plausible. In general, a case may be considered epidemiologically linked to a laboratory-confirmed case if at least one case in the chain of transmission is laboratory confirmed. Redness (or inflammation) of the skin or mucous membranes that is the result of dilation and congestion of superficial capillaries. A skin eruption or rash that may have specific diagnostic features of an infectious disease. Chickenpox, measles, roseola infantum, rubella, and smallpox are usually characterized by a particular type of exanthem. A state in which an individual has either a decreased or absent ability to mount an antibody and/or cell-mediated immune response to infectious agents. The period of time from exposure to an infecting agent to the onset of symptoms of disease. A case that is confirmed by one or more of the laboratory methods listed in the case definition under Laboratory criteria. Although other laboratory methods may be used in clinical diagnosis, only those listed are accepted for laboratory confirmation for reporting purposes. A tool used during epidemiologic investigations to allow investigators to record case information and to review and follow up case reports or conduct data analysis. Meets precisely the clinical case definition. Although in clinical practice the diagnosis may be made with the use of other criteria, for reporting purposes the stated criteria must be met. The absence of seroconversion after vaccination. This is manifest as the occurrence of disease in a vaccinated individual in which the disease occurrence closely resembles that found in natural infection with wild-type virus, i.e., more commonly moderate or severe disease. A case that is classified as probable for reporting purposes. Loss of immunity acquired after vaccination. A preventable disease, disability, or untimely death that serves as a warning signal of a possible underlying problem.

Definitions of Terms ix Sentinel surveillance Supportive laboratory results Susceptible Thermolability Vaccine coverage Vaccine effectiveness Vaccine efficacy Activities focused on monitoring key health indicators in the general population or in special populations. The primary intent is to obtain timely information needed for public health or medical action in a relatively inexpensive manner rather than to derive precise estimates of prevalence or incidence in the general population. Specified laboratory results consistent with the diagnosis but not meeting the criteria for laboratory confirmation. Being sensitive to effects of an infectious disease, allergen, or other pathogenic agent; lacking immunity or resistance. A characteristic of vaccines that cause them to lose potency when stored or held at temperatures other than that recommended by the manufacturer. The proportion or percentage of persons that have received a vaccine among all individuals in a particular group who are eligible to receive the vaccine. The ability of a vaccine to provide protection against disease when used under field conditions (e.g., use of the vaccine in routine practice). The ability of a vaccine to provide protection against disease under ideal circumstances (e.g., during a clinical trial).