Investigating the effect of the 13-valent pneumococcal conjugate vaccine on major adverse cardiovascular events among Medicare enrollees aged ≥65 years in the United States

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  PREVENAR 13
• Medical condition to be studied:
  Pneumonia

  Cardiovascular disorder

Population studied

• Short description of the study population:
  The study cohort will be identified using administrative claims. The study population includes individuals aged ≥65 years of age and enrolled in Medicare Fee-for-Service (FFS) Parts A and B as of September 14, 2014. Individuals are required to have at least 6 months of prior continuous enrollment in Medicare FFS Parts A and B as of the index date to be included in the study. Individuals with evidence of PCV13 receipt prior to index, evidence of PPSV23 receipt in the 365 days prior to index, enrollment in Medicare Part C between September 14, 2014 and index, a high-risk condition for CAP in the 365d prior to index, iatrogenic immunosuppression in the 6 months prior to index, a pneumonia diagnosis code in the hospital setting in the 365d prior to index, or a MACE event in the hospital, skilled nursing facility (SNF), or long-term care facility (LTCF) setting in the 365d prior to index will be excluded. PCV13 vaccinated time segments are excluded if the individual had a pneumonia diagnosis code in the hospital setting or a MACE diagnosis code in the hospital, SNF, or LTCF setting in the 13 days after PCV13 vaccination. For PCV13 vaccinated individuals contributing unvaccinated and vaccinated time segments, inclusion/exclusion criteria and baseline characteristics will be assessed separately for each index date.
• Age groups:
  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)

Study design details

• Study design:
  This structured secondary data collection study will be a retrospective cohort study using Centers for Medicare and Medicaid Services (CMS) Medicare data to examine the effect of PCV13 receipt on the risk of MACE among adults aged ≥65 years in the United States.
• Main study objective:
  Evaluate the effect of PCV13 receipt on the risk of major adverse cardiovascular events (MACE) at 1 and 3 years of follow-up among adults aged ≥65 years.
• Setting:
  The study period is September 14, 2014 through December 31, 2019. However, Medicare data will be used going back to 1) September 14, 2013 to assess baseline characteristics and 2) January 1, 2010 to ascertain whether the individual received a PCV13 or PPSV23 vaccine prior to the study period.; The study population includes individuals aged ≥65 years and enrolled in Medicare Fee-for-Service (FFS) Parts A and B as of September 14, 2014. Individuals are required to have at least 6 months of prior continuous enrollment in Medicare FFS Parts A and B as of the index date to be included in the study. Individuals with evidence of PCV13 receipt prior to the index date, evidence of PPSV23 receipt in the 365 days prior to the index date, enrollment in Medicare Part C between September 14, 2014 and the index date, a high-risk condition for CAP in the 365 days prior to index, iatrogenic immunosuppression in the 6 months prior to index, a pneumonia diagnosis code in the hospital setting in the 365 days prior to index, a MACE event in the hospital, skilled nursing facility (SNF), or long-term care facility (LTCF) setting in the 365 days prior to index will be excluded. PCV13 vaccinated individuals with a pneumonia diagnosis code in the hospital setting or a MACE diagnosis code in the hospital, SNF, or LTCF setting in the 13 days following first PCV13 vaccination will also be excluded.
• Data analysis plan:
  The analyses will be conducted separately at 1 year and 3 years of follow-up. ; Descriptive statistics will be used to summarize baseline characteristics by vaccination group before and after propensity score weighting. Categorical variables will be summarized using frequency counts and percentages. Continuous variables will be summarized using mean, standard deviation, median, 25th and 75th percentile, minimum, and maximum.