Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

Condition(s) targeted: Haemophilus Infections; Diphtheria; Tetanus; Polio; Pertussis

Intervention: DTaP-IPV/Hib (Biological)

Phase: N/A

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.

Overall contact:
Public Registry Sanofi Pasteur, Email: RegistryContactUs@sanofipasteur.com

To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.

Official title: Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines

Study design: Cohort, Cross-Sectional

Primary outcome: The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program.

Detailed description: The purpose of the study is to conduct surveillance for Hib disease.

Prospective active population-based surveillance for invasive Hib disease, conducted by the Center for Disease Control and Prevention (CDC) Active Bacterial Core (ABCs) program within geographic regions currently representing 12% of the US population, will provide Hib case-occurrence (numerator) data.

The ABCs program and the National Center for Health Statistics will provide annual estimates of the number of persons under surveillance, by age group, within the ABCs catchment area.

Ongoing telephone sample surveys, conducted by M/A/R/C, a national sampling organization, will provide brand-specific vaccine exposure data by age group within the ABCs program catchment area at appropriate pre-specified intervals (denominator data).

Minimum age: N/A. Maximum age: 59 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Residence within the geographic scope of Active Bacterial Core surveillance (ABCs)

during the period of surveillance

- Aged 0 through 59 months (prior to 5th birthday) on the day of inclusion for Hib

disease surveillance and 2 through 23 months (prior to 2nd birthday) for Hib vaccine brand usage survey.

- 2009-2014 calendar years inclusive.

- For the Hib vaccine usage survey, agreement to complete the required survey.

Exclusion Criteria:

Not applicable.

Public Registry Sanofi Pasteur, Email: RegistryContactUs@sanofipasteur.com

San Francisco, California 94102, United States; Recruiting

Albany, California 94706, United States; Recruiting

Martinez, California 94553, United States; Recruiting

Denver, Colorado 80012, United States; Recruiting

Aurora, Colorado 80011, United States; Recruiting

Brighton, Colorado 80601, United States; Recruiting

Castle Rock, Colorado 80108, United States; Recruiting

Applewood, Colorado 80401, United States; Recruiting

Hartford, Connecticut 06101, United States; Recruiting

Auburn, Georgia 30011, United States; Recruiting

Cartersville, Georgia 30120, United States; Recruiting

Carrollton, Georgia 30112, United States; Recruiting

Canton, Georgia 30114, United States; Recruiting

Jonesboro, Georgia 30236, United States; Recruiting

Marietta, Georgia 30090, United States; Recruiting

Newnan, Georgia 30263, United States; Recruiting

Decatur, Georgia 30030, United States; Recruiting

Douglasville, Georgia 30134, United States; Recruiting

Fayetteville, Georgia 30214, United States; Recruiting

Cumming, Georgia 30040, United States; Recruiting

Adamsville, Georgia 30331, United States; Recruiting

Hampton, Georgia 30228, United States; Recruiting

Covington, Georgia 30014, United States; Recruiting

Dallas, Georgia 30132, United States; Recruiting

Jasper, Georgia 30143, United States; Recruiting

Conyers, Georgia 30012, United States; Recruiting

Griffin, Georgia 30223, United States; Recruiting

Good Hope, Georgia 30641, United States; Recruiting

Annapolis, Maryland 21401, United States; Recruiting

St. Paul, Minnesota 55101, United States; Recruiting

Santa Fe, New Mexico 87501, United States; Recruiting

Rochester, New York 14603, United States; Recruiting

Albany, New York 12207, United States; Recruiting

Chatham, New York 12037, United States; Recruiting

Batavia, New York 14020, United States; Recruiting

Catskill, New York 12414, United States; Recruiting

Avon, New York 14414, United States; Recruiting

Amsterdam, New York 12010, United States; Recruiting

Canandaigua, New York 14424, United States; Recruiting

Geneva, New York 14456, United States; Recruiting

Medina, New York 14103, United States; Recruiting

Troy, New York 12180, United States; Recruiting

Mechanicville, New York 12118, United States; Recruiting

Schoharie, New York 12157, United States; Recruiting

Schenectady, New York 12008, United States; Recruiting

Palmyra, New York 14522, United States; Recruiting

Bellona, New York 14415, United States; Recruiting

Salem, Oregon 97301, United States; Recruiting

Ashland City, Tennessee 37015, United States; Recruiting

Nashville, Tennessee 37201, United States; Recruiting

Charlotte, Tennessee 37036, United States; Recruiting

Chattanooga, Tennessee 37402, United States; Recruiting

Knoxville, Tennessee 37902, United States; Recruiting

Springfield, Tennessee 37172, United States; Recruiting

Murfreesboro, Tennessee 37127, United States; Recruiting

Memphis, Tennessee 38103, United States; Recruiting

Gallatin, Tennessee 37066, United States; Recruiting

Franklin, Tennessee 37064, United States; Recruiting

Lebanon, Tennessee 37087, United States; Recruiting

Starting date: February 2009
Ending date: June 2015
Last updated: July 8, 2009