Impact of PCV on Disease and Colonization Among Native American Communities
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ClinicalTrials.gov Identifier: NCT01083459 |
Recruitment Status
:
Completed
First Posted
: March 9, 2010
Last Update Posted
: January 19, 2015
|
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Condition or disease |
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Pneumococcal Nasopharyngeal Colonization Invasive Pneumococcal Disease |
Study Type : | Observational |
Actual Enrollment : | 6628 participants |
Observational Model: | Family-Based |
Time Perspective: | Cross-Sectional |
Official Title: | Impact of PCV on Disease and Colonization Among Native American Communities |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | April 2012 |

Group/Cohort |
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PCV13 immunized
Children who receive the 13-valent pneumococcal conjugate vaccine
|
PCV13 unimmunized
PCV13 unimmunized Household members of PCV13 immunized children
|
- Nasopharyngeal carriage or Invasive Pneumococcal Disease caused by a PCV13 serotype [ Time Frame: Before PCV13 introduction and after 1 and 2 years of PCV13 use ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 7 Months and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- American Indian children and their families (i.e. people of all ages) who live in the Whiteriver, Fort Defiance, Chinle, Gallup, Shiprock Service Units are eligible to participate in the carriage portion of the study.
Exclusion Criteria:
- Anyone with a congenital anomaly of the nasopharynx would not be eligible to participate in the carriage portion of the study

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): NCT01083459
United States, Arizona | |
White Mountain Apache reservation | |
Whiteriver, Arizona, United States | |
United States, New Mexico | |
Navajo reservation | |
Gallup, New Mexico, United States |
Principal Investigator: | Katherine L O'Brien, MD | Johns Hopkins Bloomberg School of Public Health | |
Principal Investigator: | Lindsay R Grant, PhD | Johns Hopkins Bloomberg School of Public Health |
Responsible Party: | Katherine O'Brien, Professor, Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT01083459 History of Changes |
Other Study ID Numbers: |
R01MD004011-01 ( U.S. NIH Grant/Contract ) |
First Posted: | March 9, 2010 Key Record Dates |
Last Update Posted: | January 19, 2015 |
Last Verified: | January 2015 |
Additional relevant MeSH terms:
Pneumococcal Infections Streptococcal Infections Gram-Positive Bacterial Infections Bacterial Infections |