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Pfizer-BioNTech COVID-19 Vaccine Effectiveness Study - Kaiser Permanente Southern California

NCT04848584 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2025-07-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Primary Exposure Status of Pfizer-BioNTech COVID-19 Vaccine

prior administration of Pfizer-BioNTech COVID-19 vaccine; vaccine is not administered in this study

BIOLOGICAL

BNT162b2 BA.4/5 bivalent

Vaccination with a bivalent booster was defined as receipt of the BNT162b2 BA 4/5 bivalent vaccine ≥8 weeks (≥56 days) since the most recent dose of wild-type COVID-19 mRNA vaccine (BNT162b2 or mRNA-1273) received.

BIOLOGICAL

XBB.1.5-adapted vaccinated

Vaccinated with XBB.1.5-adapted vaccine

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-15
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04848584 on ClinicalTrials.gov