Pfizer-BioNTech COVID-19 Vaccine Effectiveness Study - Kaiser Permanente Southern California
Completed
Conditions studied: COVID-19
In brief
The primary objective of this study is to determine the vaccine effectiveness of 2 doses of Pfizer-BioNTech BNT162b2 vaccine against COVID-19-associated hospitalization. There will be a large retrospective database study using two parallel study designs: a test-negative case-control design and a retrospective cohort design. VE estimates by various strata and strain type will be conducted.
Key facts
- Study ID
- NCT04848584
- Run by
- Pfizer
- People needed
- 1
- Starts
- 2021-05-15
- Expected to finish
- 2025-04-30
- Last updated by the study team
- 2025-07-29
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- KPSC membership for a minimum of 1 year prior to index date, allowing a 30-day gap in membership to allow for delays in renewal. Participants <1 year did not have a membership requirement.≥6 months of age as of index date
- Admitted to the hospital or had an encounter in the ED, UC, or OP setting with a diagnosis of acute respiratory infection (ARI; defined based on International Classification of Diseases (ICD) codes listed in Appendix Table 1) after 25 September 2023
- Received a SARS-CoV-2 PCR or rapid antigen test
You may not qualify if…
- Individuals who received a non-Pfizer-BioNTech XBB.1.5-adapted monovalent vaccine
- Individuals with an index event <14 days after vaccination with Pfizer-BioNTech XBB.1.5-adapted monovalent vaccine
- Individuals receiving a mRNA bivalent BA4.5 booster ≤ 8 weeks (≤ 56 days) since receiving last wild type dose
- Individuals with <28 days between a second and subsequent wild type dose
- Individuals receiving a XBB.1.5-adapted monovalent vaccine ≤ 8 weeks (≤ 56 days) since receiving a mRNA bivalent BA4.5 booster
- Individuals receiving oral COVID-19 antiviral OP treatments within 30 days of index event (will be excluded for primary analysis, but included in sensitivity analyses)
Where it is running
- Kaiser Permanente Southern California — Pasadena, California, United States
Full record on ClinicalTrials.gov
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