Invasive Pneumococcal Disease Clinical Trial
Official title:
Impact of PCV on Disease and Colonization Among Native American Communities
The purpose of this study is to determine the impact of pneumococcal conjugate vaccine on carriage of pneumococcus in the nasopharynx and on the incidence of invasive pneumococcal disease in the community.
Status | Completed |
Enrollment | 6628 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 7 Months and older |
Eligibility |
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 |
Observational Model: Family-Based, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Navajo reservation | Gallup | New Mexico |
United States | White Mountain Apache reservation | Whiteriver | Arizona |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins Bloomberg School of Public Health | Centers for Disease Control and Prevention, National Institutes of Health (NIH), Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nasopharyngeal carriage or Invasive Pneumococcal Disease caused by a PCV13 serotype | Before PCV13 introduction and after 1 and 2 years of PCV13 use | No |
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