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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05540522

Registration number

NCT05540522

Ethics application status

Date submitted

8/09/2022

Date registered

14/09/2022

Date last updated

8/05/2025

Titles & IDs

Public title

A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older

Scientific title

A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA COMPARED TO LICENSED INACTIVATED INFLUENZA VACCINE IN HEALTHY ADULTS 18 YEARS OF AGE OR OLDER

Secondary ID [1]

NCT05540522

Secondary ID [2]

C4781004

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Influenza, Human

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Other - Quadrivalent influenza modRNA vaccine
Treatment: Other - Quadrivalent influenza vaccine

Experimental: Quadrivalent influenza modRNA vaccine, 18 through 64 years of age - Quadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age

Active comparator: Quadrivalent influenza vaccine, 18 through 64 years of age - Licensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age

Experimental: Quadrivalent influenza modRNA vaccine, =65 years of age - Quadrivalent influenza modRNA vaccine (single dose), participants =65 years of age

Active comparator: Quadrivalent influenza vaccine, =65 years of age - Licensed quadrivalent influenza vaccine (single dose), participants =65 years of age

Treatment: Other: Quadrivalent influenza modRNA vaccine
Quadrivalent influenza modRNA vaccine (single dose)

Treatment: Other: Quadrivalent influenza vaccine
Licensed quadrivalent influenza vaccine (single dose)

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years

Timepoint [1]

Day 15 to surveillance cut-off (approximately 6 months)

Primary outcome [2]

Percentage of Participants Reporting First Episode of Laboratory-Confirmed Influenza (LCI) Cases With Associated Per-Protocol Influenza-Like Illness (ILI) Caused by Any Strain at Least 14 Days After Vaccination: >= 65 Years

Timepoint [2]

Day 15 up to primary surveillance cut-off (approximately 1 year)

Primary outcome [3]

Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years

Timepoint [3]

From Day 1 to Day 7 after study vaccination

Primary outcome [4]

Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years

Timepoint [4]

From Day 1 to Day 7 after study vaccination

Primary outcome [5]

Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years

Timepoint [5]

From Day 1 to Day 7 after study vaccination

Primary outcome [6]

Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: >=65 Years

Timepoint [6]

From Day 1 to Day 7 after study vaccination

Primary outcome [7]

Percentage of Participants Reporting Adverse Events (AEs) From Study Vaccination Through 4 Weeks After Study Vaccination: 18-64 Years

Timepoint [7]

From study vaccination on Day 1 through 4 weeks after study vaccination

Primary outcome [8]

Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=65 Years

Timepoint [8]

From study vaccination on Day 1 through 4 weeks after study vaccination

Primary outcome [9]

Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=18 Years

Timepoint [9]

From study vaccination on Day 1 through 4 weeks after study vaccination

Primary outcome [10]

Percentage of Participants Reporting Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination: 18-64 Years

Timepoint [10]

From Day 1 up to 6 months after vaccination

Primary outcome [11]

Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=65 Years

Timepoint [11]

From Day 1 up to 6 months after vaccination

Primary outcome [12]

Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=18 Years

Timepoint [12]

From Day 1 up to 6 months after vaccination

Secondary outcome [1]

Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: 18-64 Years

Timepoint [1]

Day 15 to surveillance cut-off (approximately 6 months)

Secondary outcome [2]

Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: >=65 Years

Timepoint [2]

Day 15 up to primary surveillance cut-off (approximately 1 year)

Secondary outcome [3]

Percentage of Participants Reporting First Episode of Culture Confirmed Influenza (CCI) With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years

Timepoint [3]

Day 15 to surveillance cut-off (approximately 6 months)

Secondary outcome [4]

Percentage of Participants Reporting First Episode of CCI With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years

Timepoint [4]

Day 15 up to primary surveillance cut-off (approximately 1 year)

Secondary outcome [5]

Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified Centers for Disease Control and Prevention (CDC) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years

Timepoint [5]

Day 15 to surveillance cut-off (approximately 6 months)

Secondary outcome [6]

Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified CDC Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years

Timepoint [6]

Day 15 up to primary surveillance cut-off (approximately 1 year)

Secondary outcome [7]

Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by World Health Organization (WHO) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years

Timepoint [7]

Day 15 to surveillance cut-off (approximately 6 months)

Secondary outcome [8]

Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by WHO Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years

Timepoint [8]

Day 15 up to primary surveillance cut-off (approximately 1 year)

Secondary outcome [9]

Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: 18-64 Years

Timepoint [9]

Day 15 to surveillance cut-off (approximately 6 months)

Secondary outcome [10]

Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by Central RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: >=65 Years

Timepoint [10]

Day 15 up to primary surveillance cut-off (approximately 1 year)

Secondary outcome [11]

HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV at 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years

Timepoint [11]

4 Weeks after vaccination

Secondary outcome [12]

HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 2: >=65 Years

Timepoint [12]

4 Weeks after vaccination

Secondary outcome [13]

Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years

Timepoint [13]

4 Weeks after vaccination

Secondary outcome [14]

Timepoint [14]

4 Weeks after vaccination

Secondary outcome [15]

HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 1: 18-64 Years

Timepoint [15]

4 Weeks after vaccination

Secondary outcome [16]

HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination - Based on HAI Assay 1: >=65 Years

Timepoint [16]

4 Weeks after vaccination

Secondary outcome [17]

Timepoint [17]

4 Weeks after vaccination

Secondary outcome [18]

Timepoint [18]

4 Weeks after vaccination

Secondary outcome [19]

HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years

Timepoint [19]

Baseline (Before Vaccination)

Secondary outcome [20]

HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years

Timepoint [20]

Baseline (Before Vaccination)

Secondary outcome [21]

HAI Geometric Mean Fold Rise (GMFR) From Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years

Timepoint [21]

Before vaccination (Baseline) to 4 weeks after vaccination

Secondary outcome [22]

HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years

Timepoint [22]

Before vaccination (Baseline) to 4 weeks after vaccination

Secondary outcome [23]

Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years

Timepoint [23]

Baseline and 4 weeks after vaccination

Secondary outcome [24]

Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years

Timepoint [24]

Baseline and 4 weeks after vaccination

Secondary outcome [25]

HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years

Timepoint [25]

Baseline

Secondary outcome [26]

HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years

Timepoint [26]

Baseline

Secondary outcome [27]

HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years

Timepoint [27]

Before vaccination (Baseline) to 4 weeks after vaccination

Secondary outcome [28]

HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years

Timepoint [28]

Before vaccination (Baseline) to 4 weeks after vaccination

Secondary outcome [29]

Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years

Timepoint [29]

Baseline and 4 weeks after vaccination

Secondary outcome [30]

Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years

Timepoint [30]

Baseline and 4 weeks after vaccination

Secondary outcome [31]

HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years

Timepoint [31]

Baseline and 4 weeks after vaccination

Secondary outcome [32]

HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years

Timepoint [32]

Baseline and 4 weeks after vaccination

Secondary outcome [33]

HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern- Based on HAI Assay 2: 18-64 Years

Timepoint [33]

Before vaccination (Baseline) to 4 weeks after vaccination

Secondary outcome [34]

HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years

Timepoint [34]

Before vaccination (Baseline) to 4 weeks after vaccination

Secondary outcome [35]

Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years

Timepoint [35]

4 weeks after vaccination

Secondary outcome [36]

Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years

Timepoint [36]

4 weeks after vaccination

Secondary outcome [37]

Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years

Timepoint [37]

Baseline and 4 weeks after vaccination

Secondary outcome [38]

Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years

Timepoint [38]

Baseline and 4 weeks after vaccination

Secondary outcome [39]

HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years

Timepoint [39]

Baseline and 4 weeks after vaccination

Secondary outcome [40]

HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years

Timepoint [40]

Baseline and 4 weeks after vaccination

Secondary outcome [41]

HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 1: 18-64 Years

Timepoint [41]

Before Vaccination (baseline) to 4 weeks after vaccination

Secondary outcome [42]

HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years

Timepoint [42]

Before vaccination (baseline) to 4 weeks after vaccination

Secondary outcome [43]

Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years

Timepoint [43]

4 weeks after vaccination

Secondary outcome [44]

Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years

Timepoint [44]

4 weeks after vaccination

Secondary outcome [45]

Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years

Timepoint [45]

Baseline and 4 weeks after vaccination

Secondary outcome [46]

Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years

Timepoint [46]

Baseline and 4 weeks after vaccination

Eligibility

Key inclusion criteria

1. Male or female participants =18 years of age at Visit 1 (Day 1).
2. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
4. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
2. History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
3. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
5. Allergy to egg proteins (egg or egg products) or chicken proteins.
6. Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for =14 days at a dose of =20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
7. Receipt of blood/plasma products or immunoglobulin from 60 days before study intervention administration, or planned receipt throughout the study.
8. Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza.
9. Any participant who has received or plans to receive a modRNA-platform SARS CoV-2 vaccine within 14 days before or after study vaccination at Visit 1.
10. Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in this study.
11. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

12/09/2022

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

12/03/2024

Sample size

Target

Accrual to date

Final

45789

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Alabama

Country [2]

United States of America

State/province [2]

Arizona

Country [3]

United States of America

State/province [3]

Arkansas

Country [4]

United States of America

State/province [4]

California

Country [5]

United States of America

State/province [5]

Colorado

Country [6]

United States of America

State/province [6]

Connecticut

Country [7]

United States of America

State/province [7]

District of Columbia

Country [8]

United States of America

State/province [8]

Florida

Country [9]

United States of America

State/province [9]

Georgia

Country [10]

United States of America

State/province [10]

Hawaii

Country [11]

United States of America

State/province [11]

Idaho

Country [12]

United States of America

State/province [12]

Illinois

Country [13]

United States of America

State/province [13]

Indiana

Country [14]

United States of America

State/province [14]

Iowa

Country [15]

United States of America

State/province [15]

Kansas

Country [16]

United States of America

State/province [16]

Kentucky

Country [17]

United States of America

State/province [17]

Louisiana

Country [18]

United States of America

State/province [18]

Maryland

Country [19]

United States of America

State/province [19]

Massachusetts

Country [20]

United States of America

State/province [20]

Michigan

Country [21]

United States of America

State/province [21]

Missouri

Country [22]

United States of America

State/province [22]

Montana

Country [23]

United States of America

State/province [23]

Nebraska

Country [24]

United States of America

State/province [24]

Nevada

Country [25]

United States of America

State/province [25]

New Hampshire

Country [26]

United States of America

State/province [26]

New Jersey

Country [27]

United States of America

State/province [27]

New Mexico

Country [28]

United States of America

State/province [28]

New York

Country [29]

United States of America

State/province [29]

North Carolina

Country [30]

United States of America

State/province [30]

North Dakota

Country [31]

United States of America

State/province [31]

Ohio

Country [32]

United States of America

State/province [32]

Oklahoma

Country [33]

United States of America

State/province [33]

Oregon

Country [34]

United States of America

State/province [34]

Pennsylvania

Country [35]

United States of America

State/province [35]

Rhode Island

Country [36]

United States of America

State/province [36]

South Carolina

Country [37]

United States of America

State/province [37]

Tennessee

Country [38]

United States of America

State/province [38]

Texas

Country [39]

United States of America

State/province [39]

Utah

Country [40]

United States of America

State/province [40]

Virginia

Country [41]

United States of America

State/province [41]

Washington

Country [42]

United States of America

State/province [42]

Wisconsin

Country [43]

Argentina

State/province [43]

Santa FE

Country [44]

Argentina

State/province [44]

Tucumán

Country [45]

Argentina

State/province [45]

Buenos Aires

Country [46]

Chile

State/province [46]

Región Metropolitana DE Santiago

Country [47]

New Zealand

State/province [47]

BAY OF Plenty

Country [48]

New Zealand

State/province [48]

Canterbury

Country [49]

New Zealand

State/province [49]

Hawke's BAY

Country [50]

New Zealand

State/province [50]

Waikato

Country [51]

New Zealand

State/province [51]

Wellington

Country [52]

New Zealand

State/province [52]

Auckland

Country [53]

New Zealand

State/province [53]

Nelson

Country [54]

Philippines

State/province [54]

Iloilo

Country [55]

Philippines

State/province [55]

Metro Manila

Country [56]

Philippines

State/province [56]

National Capital Region

Country [57]

Philippines

State/province [57]

Palawan

Country [58]

Philippines

State/province [58]

Dasmarinas City

Country [59]

Philippines

State/province [59]

Dasmarinas

Country [60]

Philippines

State/province [60]

Iloilo City

Country [61]

Philippines

State/province [61]

Manila

Country [62]

South Africa

State/province [62]

Eastern CAPE

Country [63]

South Africa

State/province [63]

FREE State

Country [64]

South Africa

State/province [64]

Gauteng

Country [65]

South Africa

State/province [65]

Kwazulu-natal

Country [66]

South Africa

State/province [66]

Mpumalanga

Country [67]

South Africa

State/province [67]

North-west

Country [68]

South Africa

State/province [68]

Western CAPE

Country [69]

South Africa

State/province [69]

uMzimkhulu

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

Pfizer

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a single dose of a quadrivalent influenza modRNA vaccine compared to licensed inactivated influenza vaccine in healthy adults 18 years of age and older.

Trial website

https://clinicaltrials.gov/study/NCT05540522

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Pfizer CT.gov Call Center

Address

Pfizer

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

What supporting documents are/will be available?

Type	Other Details	Attachment
Study protocol		https://cdn.clinicaltrials.gov/large-docs/22/NCT05540522/Prot_000.pdf
Statistical analysis plan		https://cdn.clinicaltrials.gov/large-docs/22/NCT05540522/SAP_001.pdf

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT05540522

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05540522