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Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00855855
Collaborator
(none)
20,830
Enrollment
59
Locations
69.9
Actual Duration (Months)
353.1
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: DTaP-IPV/Hib

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).

Study Design

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 :
Feb 1, 2009
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Hib vaccine

Participants has received at least one dose of an Hib vaccine

Biological: DTaP-IPV/Hib
0.5 mL, Intramuscular
Other Names:
  • Pentacel®
  • ActHIB™
  • Comvax™
  • PedvaxHIB™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program. [Up to 6 years post vaccination]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 59 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Albany California United States 94706
    2 Martinez California United States 94553
    3 San Francisco California United States 94102
    4 Applewood Colorado United States 80401
    5 Aurora Colorado United States 80011
    6 Brighton Colorado United States 80601
    7 Castle Rock Colorado United States 80108
    8 Denver Colorado United States 80012
    9 Hartford Connecticut United States 06101
    10 Adamsville Georgia United States 30331
    11 Auburn Georgia United States 30011
    12 Canton Georgia United States 30114
    13 Carrollton Georgia United States 30112
    14 Cartersville Georgia United States 30120
    15 Conyers Georgia United States 30012
    16 Covington Georgia United States 30014
    17 Cumming Georgia United States 30040
    18 Dallas Georgia United States 30132
    19 Decatur Georgia United States 30030
    20 Douglasville Georgia United States 30134
    21 Fayetteville Georgia United States 30214
    22 Good Hope Georgia United States 30641
    23 Griffin Georgia United States 30223
    24 Hampton Georgia United States 30228
    25 Jasper Georgia United States 30143
    26 Jonesboro Georgia United States 30236
    27 Marietta Georgia United States 30090
    28 Newnan Georgia United States 30263
    29 Annapolis Maryland United States 21401
    30 Saint Paul Minnesota United States 55101
    31 Santa Fe New Mexico United States 87501
    32 Albany New York United States 12207
    33 Amsterdam New York United States 12010
    34 Avon New York United States 14414
    35 Batavia New York United States 14020
    36 Bellona New York United States 14415
    37 Canandaigua New York United States 14424
    38 Catskill New York United States 12414
    39 Chatham New York United States 12037
    40 Geneva New York United States 14456
    41 Mechanicville New York United States 12118
    42 Medina New York United States 14103
    43 Palmyra New York United States 14522
    44 Rochester New York United States 14603
    45 Schenectady New York United States 12008
    46 Schoharie New York United States 12157
    47 Troy New York United States 12180
    48 Salem Oregon United States 97301
    49 Ashland City Tennessee United States 37015
    50 Charlotte Tennessee United States 37036
    51 Chattanooga Tennessee United States 37402
    52 Franklin Tennessee United States 37064
    53 Gallatin Tennessee United States 37066
    54 Knoxville Tennessee United States 37902
    55 Lebanon Tennessee United States 37087
    56 Memphis Tennessee United States 38103
    57 Murfreesboro Tennessee United States 37127
    58 Nashville Tennessee United States 37201
    59 Springfield Tennessee United States 37172

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT00855855
    Other Study ID Numbers:
    • M5A15
    First Posted:
    Mar 4, 2009
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Sanofi Pasteur, a Sanofi Company
    Diphtheria
    Tetanus
    Pertussis
    Poliovirus types 1-3
    Haemophilus influenzae type b
    Pentacel®
    Additional relevant MeSH terms:
    Whooping Cough
    Tetanus
    Diphtheria
    Haemophilus Infections

    Study Results

    No Results Posted as of Apr 25, 2022