Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
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| ClinicalTrials.gov Identifier: NCT00855855 |
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Recruitment Status :
Completed
First Posted : March 4, 2009
Last Update Posted : April 25, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Haemophilus Infections Diphtheria Tetanus Polio Pertussis | Biological: DTaP-IPV/Hib |
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).
| Study Type : | Observational |
| Actual Enrollment : | 20830 participants |
| 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 |
| Actual Study Start Date : | February 2009 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2014 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Hib vaccine
Participants has received at least one dose of an Hib vaccine
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Biological: DTaP-IPV/Hib
0.5 mL, Intramuscular
Other Names:
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- 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 ]
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| Ages Eligible for Study: | up to 59 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855855
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| Study Director: | Medical Director | Sanofi Pasteur Inc. |
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00855855 |
| Other Study ID Numbers: |
M5A15 |
| First Posted: | March 4, 2009 Key Record Dates |
| Last Update Posted: | April 25, 2022 |
| Last Verified: | April 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org |
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Diphtheria Tetanus Pertussis |
Poliovirus types 1-3 Haemophilus influenzae type b Pentacel® |
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Whooping Cough Tetanus Diphtheria Haemophilus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Infections Respiratory Tract Infections Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections Corynebacterium Infections Actinomycetales Infections Pasteurellaceae Infections |