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Quadrivalent Meningococcal 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.


Effectiveness Evaluation - Abstract


 

Quadrivalent Meningococcal Conjugate Vaccine Effectiveness Among Adolescents and Young Adults

Background: A quadrivalent meningococcal conjugate vaccine (MCV4) was licensed in January 2005. Post-licensure evaluation of MCV4 effectiveness is important to ensure that the vaccine performs as expected among adolescents and young adults recommended to receive the vaccine.

Objectives: Evaluation is to determine the effectiveness of MCV4 against invasive meningococcal disease (IMD) caused by vaccine‐preventable serogroups (A, C, Y, W135), and the serogroupspecific effectiveness of MCV4 against serogroups C and Y meningococcal disease among adolescents.

Design: Matched case-control evaluation.

Participants: The evaluation will enroll persons aged > 11 years and born on or after January 1, 1986 identified as having meningococcal disease caused by a vaccine-preventable serogroup through routine active bacterial core surveillance. Identified friend or school controls will be matched by age and geographic area. Every effort will be made to enroll two controls for each case.

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 that IMD caused by the serogroups included in MCV4. Potential confounders will be evaluated and controlled for when necessary: indication for vaccination, underlying health conditions and other risk factors, including recent illnesses, family income, ages and number of persons living in the home, steroid use, and social activities. To measure vaccine effectiveness, CDC will calculate an adjusted, matched odds ratio (mOR) for the odds of vaccination among cases and controls. Also, a stratified analysis will be performed to determine if the results are different using friend or school controls. If no significant difference is found, friend and school controls will be combined for analysis.


Sponsor: Centers for Disease Control & Prevention, US Department of Health & Human Services
Start date: January 1, 2006
Expected end date: December 2012


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