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13-Valent Pneumococcal Conjugate Vaccine Effectiveness Evaluation

The U.S. Centers for Disease Control and Prevention (CDC) launched the Emerging Infections Program (EIP) to develop centers of excellence in infectious disease surveillance and applied public health research in selected state health departments. The Oregon EIP is participating in the study described below. 

13‐Valent Pneumococcal Conjugate Vaccine Among Children

Effectiveness Evaluation - Abstract

Background: A new 13‐valent pneumococcal conjugate vaccine (PCV13, Pfizer) was licensed in February 2010. Post‐licensure evaluation of PCV13 effectiveness is important to ensure that the vaccine performs as expected among children who receive it through the routine immunization program.

Objectives: Evaluation is to determine the effectiveness of PCV13 against invasive pneumococcal disease (IPD) caused by vaccine serotypes in the population of children recommended to receive PCV13. It is expected that the vaccine will be highly effective at preventing IPD, even in children who do not receive the full four-dose schedule.

Design: Matched case-control evaluation.

Participants: The evaluation will enroll children identified as having IPD by routine ABCs and epidemiology and laboratory capacity for infectious diseases (ELC) sites. Children meeting the ABCs case definition who are recommended to receive PCV13 as part of the routine immunization schedule and whose pneumococcal isolate is available for serotyping will be eligible for enrollment. Using birth certificates, site collaborators will identify four controls for each case. Controls will be matched to cases by age and mother’s zip code of residence at time of birth.

Data collection: Project personnel at each site will contact cases and controls and, after obtaining informed consent, conduct an interview to assess history of vaccination and potential confounding factors. After the interview, state-based project personnel will contact health care providers to confirm vaccination status. Data will be sent to CDC monthly, where it will be aggregated and checked for completeness.

Outcome and analyses: The primary outcome is IPD caused by the group of serotypes included in PCV13. Evaluators will use a matched case-control methodology, comparing the odds of PCV13 receipt among cases and controls and adjusting for the presence of confounders, such as underlying illnesses. Secondary objectives include measuring the effectiveness of the vaccine against IPD caused by the six serotypes unique to PCV13 and against IPD caused by drug resistant strains. Evaluators will determine the effectiveness of PCV13 in children who have received mixed schedules of PCV7 and PCV13, children with underlying medical conditions, and African-American children. The evaluation will also assess whether receipt of PCV13 leads to an increased risk of IPD caused by non-vaccine serotypes, and evaluators will assess known risk factors for IPD (e.g., passive smoking, previous influenza infection) among children recommended to receive PCV13.

Sponsor: U.S. Centers for Disease Control & Prevention, US Department of Health & Human Services
Start date: June 1, 2010
Expected end date: January 2014

To see all Oregon Emerging Infections Program special studies go to EIP special studies.

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