Long-term Impact of Pneumococcal Conjugate Vaccine on Carriage
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00294021
: February 20, 2006
Last Update Posted
: September 26, 2012
Johns Hopkins Bloomberg School of Public Health
Centers for Disease Control and Prevention
Institute of Child Health
Finnish Public Health Institute
Thrasher Research Fund
Grand Challenges in Global Health
Information provided by (Responsible Party):
Katherine O'Brien, Johns Hopkins Bloomberg School of Public Health
Pneumococcus is a major cause of morbidity and mortality. In 2000, a pneumococcal conjugate vaccine (PCV) was licensed for use in children and is now part of the routine childhood vaccine schedule. PCV is known to reduce invasive disease and protect against nasopharyngeal (NP) acquisition of vaccine serotype pneumococci; it also results in an increased risk of nonvaccine serotype carriage. This study proposes to assess the longterm impact of vaccine on NP carriage in a setting where there is intense antibody pressure on the ecology of the pneumococcus. A cross sectional study of pneumococcal NP colonization among American Indian children will be combined with surveillance for invasive disease in the same population. The purpose is to determine the impact of community wide PCV use on NP colonization and the relationship with invasive disease. This longterm safety issue needs to be assessed to fully evaluate the impact of vaccine on NP ecology and invasive disease.
Condition or disease
There are four specific aims for this study: (1) to determine the overall and serotype specific prevalence and incidence of pneumococcal carriage among children and adults at high risk for carriage and disease in the era of routine pneumococcal conjugate vaccine (PCV) use compared with those measures in the same population prior to use of PCV vaccine; (2) to characterize the intrafamilial NP transmission of clones among those living with children less than 8 years of age; (3) to determine the immune correlates of protection from serotype specific pneumococcal carriage among individuals immunized and not immunized with PCV; and (4) to determine the relative invasiveness of serotypes of pneumococcus during an era of widespread PCV use and compare this to the relative invasiveness of serotypes prior to routine use of PCV.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adults and children living on the Navajo or White Mountain Apache reservations
Inclusion Criteria for the Family to Participate.
At least one parent is a member of the Navajo or White Mountain Apache Tribe
Family home is on or near the Navajo or Apache reservation
At least one child in the household is 8 years of age or younger (minimum age of eligibility: birth)
At least one child in the household is fully immunized with Prevnar.
At least two people in the household will participate in the study
Willingness to participate for a 6-month time period
Exclusion Criteria for the Family to Participate.
1. Family will be moving off reservation during the study period