Impact of PCV on Disease and Colonization Among Native American Communities

NCT01083459 | Completed

• 1 other identifier: R01MD004011-01
• Study Type: observational
• Target: 6,628
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pneumococcal Nasopharyngeal Colonization; Invasive Pneumococcal Disease

Outcome Measures

Primary Outcomes (1)

• Nasopharyngeal carriage or Invasive Pneumococcal Disease caused by a PCV13 serotype

  Before PCV13 introduction and after 1 and 2 years of PCV13 use

Study Arms (2)

PCV13 immunized

Children who receive the 13-valent pneumococcal conjugate vaccine

PCV13 unimmunized

PCV13 unimmunized Household members of PCV13 immunized children

Eligibility Criteria

• Age: 7 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population for the nasopharyngeal study is American Indian children 7-24 months of age (index child) and their adult and child household members who reside in the Whiteriver, Shiprock, Chinle, Fort Defiance and Gallup service units on the White Mountain Apache and Navajo reservations. In addition those children and adults who have close contact with the index child but may not live in the same household as the child are eligible to participate. This may be relatives or close contacts of the index child who reside in the same family compound (a compound is a group of homes in close proximity to each other) but do not live in the same household as the index child.

You may qualify if:

• 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.

You may not qualify if:

• Anyone with a congenital anomaly of the nasopharynx would not be eligible to participate in the carriage portion of the study

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institutes of Health (NIH): collaborator
• Centers for Disease Control and Prevention: collaborator
• Pfizer: collaborator

Study Sites (2)

White Mountain Apache reservation

Whiteriver, Arizona, United States

Location

Navajo reservation

Gallup, New Mexico, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab Blood

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

US (2)