Clinical trial NCT00855855: Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
Official title: Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemophilus Infections
Diphtheria
Tetanus
Polio
Pertussis
Keywords: Diphtheria
Tetanus
Pertussis
Poliovirus types 1-3
Haemophilus influenzae type b
Pentacel®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-03-04
Enrollment: 20830
Sex: ALL
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 5.2 million person years over the 6 year study period

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

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).

Eligibility 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.

Primary outcomes:
measure: The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program.
timeFrame: Up to 6 years post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
state: California
city: Martinez
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Applewood
country: United States
state: Colorado
city: Aurora
country: United States
state: Colorado
city: Brighton
country: United States
state: Colorado
city: Castle Rock
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Hartford
country: United States
state: Connecticut
city: Adamsville
country: United States
state: Georgia
city: Auburn
country: United States
state: Georgia
city: Canton
country: United States
state: Georgia
city: Carrollton
country: United States
state: Georgia
city: Cartersville
country: United States
state: Georgia
city: Conyers
country: United States
state: Georgia
city: Covington
country: United States
state: Georgia
city: Cumming
country: United States
state: Georgia
city: Dallas
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Douglasville
country: United States
state: Georgia
city: Fayetteville
country: United States
state: Georgia
city: Good Hope
country: United States
state: Georgia
city: Griffin
country: United States
state: Georgia
city: Hampton
country: United States
state: Georgia
city: Jasper
country: United States
state: Georgia
city: Jonesboro
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Newnan
country: United States
state: Georgia
city: Annapolis
country: United States
state: Maryland
city: Saint Paul
country: United States
state: Minnesota
city: Santa Fe
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Amsterdam
country: United States
state: New York
city: Avon
country: United States
state: New York
city: Batavia
country: United States
state: New York
city: Bellona
country: United States
state: New York
city: Canandaigua
country: United States
state: New York
city: Catskill
country: United States
state: New York
city: Chatham
country: United States
state: New York
city: Geneva
country: United States
state: New York
city: Mechanicville
country: United States
state: New York
city: Medina
country: United States
state: New York
city: Palmyra
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Schenectady
country: United States
state: New York
city: Schoharie
country: United States
state: New York
city: Troy
country: United States
state: New York
city: Salem
country: United States
state: Oregon
city: Ashland City
country: United States
state: Tennessee
city: Charlotte
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Franklin
country: United States
state: Tennessee
city: Gallatin
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Lebanon
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Murfreesboro
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Springfield
country: United States
state: Tennessee
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: