Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

COMIRNATY
VAXZEVRIA

Name of medicine, other

COVID-19 Vaccine Moderna dispersion for injection, COVID-19 Vaccine Janssen suspension for injection

Anatomical Therapeutic Chemical (ATC) code

(J07BX03) covid-19 vaccines
covid-19 vaccines

Medical condition to be studied

SARS-CoV-2 test positive

Additional medical condition(s)

Symptomatic or Asymptomatic Diagnosis of COVID-19,Hospitalisations/Intensive care unit (ICU) admissions for COVID-19 All-Cause Mortality
Population studied

Age groups

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

8
Study design details

Main study objective

This study addresses the research question of whether vaccinations with new licenced COVID 19 vaccines, (Comirnaty, Moderna, AstraZeneca’s and Janssen and subsequently approved vaccines in the EU during the data collection), are effective in reducing the burden of COVID 19 in Spain in comparison with no vaccination person-time.

Outcomes

Primary objective is to evaluate the effectiveness of each COVID-19 vaccine in reducing the covid-19 infections (confirmed through test and regardless the prognosis and clinical phenotype (i.e. whether symptomatic or asymptomatic, mild or severe). Effectiveness of each covid-19 vaccine in reducing asymptomatic or symptomatic COVID-19, Hospitalisations/Intensive care unit (ICU) admissions for COVID 19 and All-cause mortality. Effectiveness of each covid-19 vaccine in reducing the covid-19 infections among different clinical subgroups of patients, and along the time since complete vaccination.

Data analysis plan

Cox proportional hazards regression, yielding a hazard ratio (HR, 95%CI) will be estimated for 0-14 days after D1, 15 after D1 until D2, 0-14 days after D2 and 15-90d,91-180d,and ≥181d after D2 in comparison with similar followed periods from time zero in the unvaccinated group. This method will calculate a single vaccine effectiveness measure for each period of observation (assumed constant over those defined periods) in vaccinated versus unvaccinated groups.Flexible parametrical models will be run for comparison.Crude vaccine effectiveness (1-HR) will be calculated for all outcomes.Backward stepwise selection will be used to identify variables associated with outcome (p-exit≥0.1, p-entry<0.05), that could be confounders and thus adjust the final models. Confounders will be measured at baseline and updated before each vaccine dose or every 28 days. Adjusted time-specific risk differences (at 3, 6, 9, 12 months) will be calculated.Switching among vaccines will be analysed separately.
Documents
Study results
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