ACCESS template protocols for effectiveness of COVID-19 vaccines (ACCESS-effectiveness)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary and secondary data collection

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

  Other
• Non-interventional study design, other:
  Sentinel sites

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07X) OTHER VACCINES
• Medical condition to be studied:
  SARS-CoV-2 test positive

Population studied

• Short description of the study population:
  Cohort study: This study should be conducted in populations where COVID-19 vaccine product is approved and recommended for use.; Case-control: All-ages patients admitted to the hospital, through the Emergency Department or transferred from other hospitals or health facilities, fulfilling the ECDC case definition for COVID-19 disease.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  To assess COVID-19 vaccine effectiveness
• Data analysis plan:
  Estimation of vaccine effectiveness