A Phase 4 Observational, Real-World Study of 20-valent Pneumococcal Conjugate Vaccine Effectiveness Against Vaccine-Type Invasive Pneumococcal Disease in Adults Aged 65 years and above

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  No individual level data collected for the purpose of the study

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Name of medicine:
  APEXXNAR
• Name of medicine, other:
  Prevenar 20
• Anatomical Therapeutic Chemical (ATC) code:
  (J07AL) Pneumococcal vaccines

  Pneumococcal vaccines

  (J07AL02) pneumococcus, purified polysaccharides antigen conjugated

  pneumococcus, purified polysaccharides antigen conjugated
• Medical condition to be studied:
  Severe invasive streptococcal infection
• Additional medical condition(s):
  Invasive pneumococcal disease (IPD)

Population studied

• Short description of the study population:
  Adults aged 65 years and above with IPD with an identified pneumococcal serotype who were reported to the study site surveillance system and were eligible for 20vPnC vaccination, according to local vaccination policies.
• 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:
  A multi-country observational study using the indirect cohort (Broome) method will be conducted, in which cases are IPD caused by vaccine serotypes and controls are IPD caused by non-20vPnC serotypes.
• Main study objective:
  To estimate vaccine effectiveness of 20vPnC against IPD due to any of the 20 serotypes that are included in the vaccine (20vPnC serotypes), in adults aged 65 years and above.
• Setting:
  Study sites are national or regional surveillance systems, or hospital research networks, selected based on existing 20vPnC recommendation in adults, expected vaccine uptake, expected number of serotyped IPD cases, and availability of data on vaccination status. IPD data for all adults aged 18 years and above will be collected to monitor serotyping distribution. Participating sites will contribute up to four years of data.
• Comparators:
  NA
• Outcomes:
  Primary outcome will be IPD due to any of the 20vPnC serotypes; ; Secondary outcomes: IPD due to any of the 13vPnC serotypes; and IPD due to any of the 7 20non13vPnC serotypes
• Data analysis plan:
  Study sites will submit a de-identified dataset to the study sponsor (P95). Descriptive statistics for every site and pooled for all sites will be performed. For every objective, unadjusted and adjusted VE against vaccine serotype IPD will be estimated as VE = (1-odds ratio (OR)) x 100%, where OR denotes the odds ratio, comparing the odds of vaccination among vaccine serotype IPD (cases) to the odds of vaccination among non-vaccine serotype IPD (controls). VE estimates will be adjusted for the major confounding factors (i.e., study site, year of IPD diagnosis, age). Previous pneumococcal vaccination will be considered in the analysis. VE pooled estimates will be stratified by age group and time since 20vPnC vaccination (e.g., <2 years, 2-5 years after vaccination).