N/A
Completed N=3,442,996
This Study Intends to Describe the Characteristics of Patients Given the Pfizer-BioNTech Bivalent mRNA COVID-19 Vaccine and Any Commercially Available Influenza Vaccines at the Same Time Versus at Different Times.
Influenza, Human · COVID
Source: ClinicalTrials.gov NCT05858450 ↗
Enrolled (actual)
3,442,996
Serious AEs
—
Results posted
Sep 2024
Primary outcomePrimary: Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old — 1838; 705; 1837; 12715 Participants
Summary
This study intends to describe the characteristics of patients given the Pfizer-BioNTech bivalent mRNA COVID-19 vaccine and any commercially available influenza vaccines at the same time versus at different times.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old |
1838; 705; 1837; 12715 | — |
| PRIMARY Number of Participants With All Cause Hospitalization Visits: >=65 Years Old |
7753; 2719; 7751; 33926 | — |
| PRIMARY Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone |
181; 55; 2085; 684 | — |
| PRIMARY Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone |
145; 770; 953; 3936 | — |
| PRIMARY Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone |
3513; 1399; 6473; 2268 | — |
| PRIMARY Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone |
1346; 6200; 1457; 6396 | — |
| PRIMARY Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone |
57; 14; 452; 164 | — |
| PRIMARY Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone |
47; 228; 232; 1164 | — |
| PRIMARY Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone |
127; 41; 1674; 535 | — |
| PRIMARY Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone |
100; 558; 736; 2870 | — |
Eligibility Criteria
Inclusion Criteria
- Enrolled in Optum claims database as of 31 August 2022 (date bivalent authorized).
- Has a Pfizer-BioNTech mRNA bivalent COVID-19 or influenza vaccine (any type) between 31 August 2022 and 30 January 2023 (earliest vaccine is index date).
- Aged >=18 years on the index date
- 365 days of continuous enrolment prior to index date
Exclusion Criteria
- Patients with a second dose of any type of bivalent mRNA COVID-19 or flu vaccine, disenrolled or died within 14 days following the first dose.
- Has prior COVID-19 diagnosis (U07.1, any setting, any position) within 90 days (per CDC guidance on length of time before receiving a vaccine) before and on index.
- Has influenza vaccine between 01 August -30 August 2022 (before study period).
- Has a COVID-19 or influenza diagnosis code in any setting within 14 days after index vaccination (excluded from all cohorts).
Data sourced from ClinicalTrials.gov (NCT05858450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.