Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00855855
First received: March 3, 2009
Last updated: April 12, 2016
Last verified: April 2016
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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 |
Resource links provided by NLM:
Drug Information available for:
Comvax
Genetic and Rare Diseases Information Center resources:
Whooping Cough
Tetanus
Diphtheria
Haemophilus Influenzae
Poliomyelitis
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program. [ Time Frame: Up to 6 years post vaccination ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 520000 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2016 |
| Primary Completion Date: | June 2015 (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 (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
5.2 million person years over the 6 year study period
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:
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855855
Show 59 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855855
Show 59 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
More Information
Additional Information:
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00855855 History of Changes |
| Other Study ID Numbers: | M5A15 |
| Study First Received: | March 3, 2009 |
| Last Updated: | April 12, 2016 |
| 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:
|
Whooping Cough Tetanus Diphtheria Haemophilus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Respiratory Tract Infections Infection |
Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections Corynebacterium Infections Actinomycetales Infections Pasteurellaceae Infections Vaccines Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 26, 2016