Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
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Purpose
To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.
| Condition | Intervention |
|---|---|
|
Haemophilus Infections Diphtheria Tetanus Polio Pertussis |
Biological: DTaP-IPV/Hib |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines |
- The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program. [ Time Frame: Entire study period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 520000 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Hib vaccine
Participants has received at least one dose of an Hib vaccine
|
Biological: DTaP-IPV/Hib
0.5 mL, Intramuscular
Other Names:
|
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| Ages Eligible for Study: | up to 59 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
5.2 million person years over the 6 year study period
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.
Contacts and Locations| Contact: Public Registry Sanofi Pasteur | RegistryContactUs@sanofipasteur.com |
Show 59 Study Locations| Study Director: | Medical Director | Sanofi Pasteur Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00855855 History of Changes |
| Other Study ID Numbers: | M5A15 |
| Study First Received: | March 3, 2009 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Diphtheria Tetanus Pertussis |
Poliovirus types 1-3 Haemophilus influenzae type b Pentacel® |
Additional relevant MeSH terms:
|
Poliomyelitis Diphtheria Haemophilus Infections Whooping Cough Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Pasteurellaceae Infections Gram-Negative Bacterial Infections Bordetella Infections Respiratory Tract Infections Infection |
Respiratory Tract Diseases Myelitis Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations |
ClinicalTrials.gov processed this record on May 21, 2013