Influenza, HumanNCT05858450

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.

An observational study of Influenza, Human and COVID-19, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Influenza, Human, COVID-19
What is being tested?: Comirnaty and Quadrivalent Influenza Vaccine
Type of treatment: Vaccines
How many people: 3,442,996 participants
Where: 1 siteUnited States
Study dates: 5 May 2023to 12 May 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population will include adults patients who were enrolled in the Optum Clinformatics Database as of 31 August 2022

Who may be able to join

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

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer
New York, New York, 10001

Other trials in United States

About this study

Official title: Investigating Uptake and Subsequent Health Outcomes Associated With Pfizer-BioNTech Bivalent COVID-19/Influenza Vaccine Concomitant Administration Using a Claims-based Real-world Data Source in the US

Conditions: Influenza, Human, COVID-19
Being tested: Comirnaty, Quadrivalent Influenza Vaccine
Medical subject headings: Influenza, Human, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ComirnatyBiological
COMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
Quadrivalent Influenza VaccineBiological
Quadrivalent Influenza Vaccine is a class of vaccines indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccines

Study groups in NCT05858450
Study group	Role	What they receive
Same day		Pfizer-BioNTech mRNA bivalent COVID and flu on the same day Receives: Biological: Comirnaty; Biological: Quadrivalent Influenza Vaccine
COVID alone		Pfizer-BioNTech bivalent COVID only Receives: Biological: Comirnaty
flu alone		influenza vaccine of any type only Receives: Biological: Quadrivalent Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old
Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs Flu (SIV) alone.
Measured: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Number of Participants With All Cause Hospitalization Visits: >=65 Years Old
Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone.
Measured: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone
Hospitalization, emergency department or urgent care visits with COVID-19 diagnosis code (International Classification of Diseases, 10th revision [ICD-10-CM]: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.
Measured: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone
Hospitalization, emergency department or urgent care visits with Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.
Measured: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone
COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. An outpatient visit refers to any encounter that is in the outpatient setting. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.
Measured: From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone
Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. An outpatient visit refers to any encounter that is in the outpatient setting. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.
Measured: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone
COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.
Measured: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone
Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.
Measured: From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone
COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.
Measured: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone
Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.
Measured: From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 202312 May 2023

First posted15 May 2023
Study start5 May 2023
Primary completion12 May 2023
Study completion12 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Influenza, HumanStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 3,442,996 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05858450
Sponsor's protocol ID: C4591061
Status last verified: May 2024
First submitted: 11 May 2023
Last updated: 20 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigating Uptake and Subsequent Health Outcomes Associated With Pfizer-BioNTech Bivalent COVID-19/Influenza Vaccine Concomitant Administration Using a Claims-based Real-world Data Source in the US
ClinicalTrials.gov ID: NCT05858450
Acronym / sponsor ID: C4591061
Conditions: Influenza, Human, COVID-19
Study type: Observational
Recruitment status: Completed
Enrolment: 3,442,996 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 5 May 2023 (actual)
Primary completion: 12 May 2023 (actual)
Study completion: 12 May 2023 (actual)
First posted: 15 May 2023 (actual)
Results: Posted 20 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
Same day	–	Biological: Comirnaty, Biological: Quadrivalent Influenza VaccinePfizer-BioNTech mRNA bivalent COVID and flu on the same day
COVID alone	–	Biological: ComirnatyPfizer-BioNTech bivalent COVID only
flu alone	–	Biological: Quadrivalent Influenza Vaccineinfluenza vaccine of any type only

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population will include adults patients who were enrolled in the Optum Clinformatics Database as of 31 August 2022

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ComirnatyCOMIRNATY is an active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.	Biological	COVID alone, Same day
Quadrivalent Influenza VaccineQuadrivalent Influenza Vaccine is a class of vaccines indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccines	Biological	Same day, flu alone

Primary outcome

Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old
Time frame: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs Flu (SIV) alone.
Number of Participants With All Cause Hospitalization Visits: >=65 Years Old
Time frame: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Hospitalization due to any cause is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility). To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone.
Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone
Time frame: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Hospitalization, emergency department or urgent care visits with COVID-19 diagnosis code (International Classification of Diseases, 10th revision [ICD-10-CM]: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.
Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone
Time frame: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Hospitalization, emergency department or urgent care visits with Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.
Number of Participants With COVID-19 Related Outpatient Visits: Same Day Versus COVID-19 Alone
Time frame: From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. An outpatient visit refers to any encounter that is in the outpatient setting. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.
Number of Participants With Influenza-Related Outpatient Visits: Same Day Versus SIV Alone
Time frame: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. An outpatient visit refers to any encounter that is in the outpatient setting. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.
Number of Participants With COVID-19 Related Hospitalization Visits: Same Day Versus COVID-19 Alone
Time frame: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.
Number of Participants With Influenza Related Hospitalization Visits: Same Day Versus SIV Alone
Time frame: From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.
Number of Participants With COVID-19-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus COVID-19 Alone
Time frame: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
COVID-19 diagnosis code (ICD-10-CM: U07.1) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 1: Same day vs COVID-19 alone.
Number of Participants With Influenza-Related Emergency Department Visits/ Urgent Care Visits: Same Day Versus SIV Alone
Time frame: From Day 15 of vaccination till end of follow-up observation period, (from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)
Influenza diagnosis code (ICD-10-CM: J09.X, J10.X, J11.X) in any position. To account for imbalance in participant characteristics between the vaccine exposure groups, 2 separate logistic regression models were used. The two models were: Model 1: Same day vs COVID-19 alone, and Model 2: Same day vs SIV alone. In this outcome measure data is reported for Model 2: Same day vs SIV alone.

Results and safety

Results posted to the registry on 20 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1a: Same Day COVID-19 Vaccine and SIV, 18-64 Years	244,900	244,900
Group 2a: COVID-19 Vaccine Alone, 18-64 Years	143,743	143,743
Group 3a: SIV Alone, 18-64 Years	843,860	843,860
Group 1b: Same Day COVID-19 Vaccine and SIV, >= 65 Years	382,835	382,835
Group 2b: COVID-19 Vaccine Alone, >=65 Years	225,680	225,680
Group 3b: SIV Alone, >=65 Years	1,601,978	1,601,978

Primary outcome: Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old

Time frame: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days). Count of participants. Unit: Participants

Measure	Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years n = 244900	Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years n = 143743	Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years n = 244820	Group 3a, Model 2: SIV Alone, 18-64 Years n = 843412
Value	1838	705	1837	12715

Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years vs Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years: Weighted Hazard Ratio: 1.108 (95% CI 1.018 to 1.205)
Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years vs Group 3a, Model 2: SIV Alone, 18-64 Years: Weighted Hazard Ratio: 0.634 (95% CI 0.606 to 0.664)

Population analysed: All eligible participants whose data were observed in this study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years of age for both models: Model 1 (reporting arms included were co-administration of vaccines on the same day and COVID-19 alone), Model 2 (reporting arms included were co-administration of vaccines on the same day \[excluded participants with unknown/other region\] and SIV alone).

Primary outcome: Number of Participants With All Cause Hospitalization Visits: >=65 Years Old

Measure	Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years n = 382835	Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years n = 225680	Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years n = 382626	Group 3b, Model 2: SIV Alone, >=65 Years n = 1600981
Value	7753	2719	7751	33926

Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years vs Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years: Weighted Hazard Ratio: 1.061 (95% CI 1.016 to 1.107)
Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years vs Group 3b, Model 2: SIV Alone, >=65 Years: Weighted Hazard Ratio: 0.897 (95% CI 0.875 to 0.919)

Population analysed: All eligible participants whose data were observed in this study. This outcome measure presents reporting arms as planned based on the following: participants \>=65 years of age for both models: Model 1 (reporting arms included were co-administration of vaccines on the same day and COVID-19 alone), Model 2 (reporting arms included were co-administration of vaccines on the same day \[excluded participants with unknown/other region\] and SIV alone).

Primary outcome: Number of Participants With Composite Coronavirus Disease (COVID-19)-Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus COVID-19 Alone

Measure	Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years n = 244900	Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years n = 143743	Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years n = 382835	Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years n = 225680
Value	181	55	2085	684

Group 1a, Model 1: Same Day (COVID-19 Vaccine and SIV), 18-64 Years vs Group 2a, Model 1: COVID-19 Vaccine Alone, 18-64 Years: Weighted Hazard Ratio: 1.543 (95% CI 1.133 to 2.1)
Group 1b, Model 1: Same Day (COVID-19 Vaccine and SIV), >=65 Years vs Group 2b, Model 1: COVID-19 Vaccine Alone, >=65 Years: Weighted Hazard Ratio: 1.106 (95% CI 1.014 to 1.206)

Population analysed: All eligible participants whose data were observed in this retrospective observational study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years and \>=65 years of age for Model 1 (reporting arms included were co-administration of vaccines on the same day and COVID-19 alone).

Primary outcome: Number of Participants With Composite Influenza Related Hospitalization, Emergency Department or Urgent Care Visits: Same Day Versus SIV Alone

Measure	Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years n = 244820	Group 3a, Model 2: SIV Alone, 18-64 Years n = 843412	Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years n = 382626	Group 3b, Model 2: SIV Alone, >=65 Years n = 1600981
Value	145	770	953	3936

Group 1a, Model 2: Same Day (COVID-19 Vaccine and SIV), 18-64 Years vs Group 3a, Model 2: SIV Alone, 18-64 Years: Weighted Hazard Ratio: 1.048 (95% CI 0.903 to 1.217)
Group 1b, Model 2: Same Day (COVID-19 Vaccine and SIV), >=65 Years vs Group 3b, Model 2: SIV Alone, >=65 Years: Weighted Hazard Ratio: 0.908 (95% CI 0.846 to 0.973)

Population analysed: All eligible participants whose data were observed in this retrospective observational study. This outcome measure presents reporting arms as planned based on the following: participants 18-64 years and \>=65 years of age for Model 2 (reporting arms included were co-administration of vaccines on the same day \[excluded participants with unknown/other region\] and SIV alone).

Adverse events

Time frame: All-cause mortality: From Day 1 of vaccination till end of follow-up observation period (approx. 5.5 months, data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 [8 days]); SAEs and Other AEs: Not applicable as safety data not collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1a: Same Day COVID-19 Vaccine and SIV, 18-64 Years	0 of 0	0 of 0	110 of 244,900
Group 2a: COVID-19 Vaccine Alone, 18-64 Years	0 of 0	0 of 0	63 of 143,743
Group 3a: SIV Alone, 18-64 Years	0 of 0	0 of 0	794 of 843,860
Group 1b: Same Day COVID-19 Vaccine and SIV, >= 65 Years	0 of 0	0 of 0	2,160 of 382,835
Group 2b: COVID-19 Vaccine Alone, >=65 Years	0 of 0	0 of 0	1,402 of 225,680
Group 3b: SIV Alone, >=65 Years	0 of 0	0 of 0	12,031 of 1,601,978

Limitations and caveats (from the sponsor): 1. COVID-19 and influenza vaccinations may have been under-ascertained. 2. The study population included employer-sponsored health plans and Medicare Advantage, which may limit generalizability. 3. It was possible that unmeasured residual confounding remained. 4. Effectiveness for individual influenza vaccines was not assessed. 5. COVID-19 and influenza endpoints were identified using diagnosis codes rather than via laboratory confirmation. 6. This study included only one respiratory virus season.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Influenza, Human and COVID-19, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With All Cause Hospitalization Visits: 18-64 Years Old (time frame: From Day 15 of vaccination till end of follow-up observation period, from 14-Sep-2022 through 14 February 2023 (approximately 5 months); data was extracted and observed in this retrospective study from 05-May-2023 to 12-May-2023 (8 days)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05858450.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.