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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

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] 0 0
C4781004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza, Human 0 0
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] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of participants reporting laboratory-confirmed influenza (LCI) cases with associated per-protocol influenza-like illness (ILI) in each vaccine group, 18 through 64 years of age
Timepoint [1] 0 0
At least 14 days after vaccination
Primary outcome [2] 0 0
The proportion of participants reporting laboratory-confirmed influenza (LCI) cases with associated per-protocol influenza-like illness (ILI) in each vaccine group, =65 years of age
Timepoint [2] 0 0
At least 14 days after vaccination
Primary outcome [3] 0 0
Percentage of participants reporting local reactions, 18 through 64 years of age and =65 years of age separately
Timepoint [3] 0 0
For up to 7 days following vaccination
Primary outcome [4] 0 0
Percentage of participants reporting systemic events, 18 through 64 years of age and =65 years of age separately
Timepoint [4] 0 0
For up to 7 days following vaccination
Primary outcome [5] 0 0
Percentage of participants reporting adverse events, 18 through 64 years of age and =65 years of age separately and combined
Timepoint [5] 0 0
From the time the participant provides informed consent through 4 weeks after vaccination
Primary outcome [6] 0 0
Percentage of participants reporting serious adverse events, 18 through 64 years of age and =65 years of age separately and combined
Timepoint [6] 0 0
From the time the participant provides informed consent through 6 months after vaccination
Secondary outcome [1] 0 0
The proportion of participants reporting LCI cases with associated per-protocol ILI caused by all matched strains, each matched strain, or unmatched strains in each vaccine group, 18 through 64 years of age and =65 years of age separately
Timepoint [1] 0 0
At least 14 days after vaccination
Secondary outcome [2] 0 0
The proportion of participants reporting culture-confirmed influenza (CCI) cases with associated per-protocol ILI in each vaccine group, 18 through 64 years of age and =65 years of age separately
Timepoint [2] 0 0
At least 14 days after vaccination
Secondary outcome [3] 0 0
The proportion of participants reporting LCI associated with ILI, as defined by applying a modified CDC definition, in each vaccine group, 18 through 64 years of age and =65 years of age separately
Timepoint [3] 0 0
At least 14 days after vaccination
Secondary outcome [4] 0 0
The proportion of participants reporting LCI cases associated with ILI, as defined by applying the WHO definition, in each vaccine group, 18 through 64 years of age and =65 years of age separately
Timepoint [4] 0 0
At least 14 days after vaccination
Secondary outcome [5] 0 0
The proportion of participants reporting cases of influenza, as confirmed by central RT-PCR, local RT-PCR or culture, with associated per-protocol ILI in each vaccine group, 18 through 64 years of age and =65 years of age separately
Timepoint [5] 0 0
At least 14 days after vaccination
Secondary outcome [6] 0 0
Geometric mean ratio (GMR) of hemagglutination inhibition (HAI) titers for each strain in qIRV recipients compared to QIV recipients, 18 through 64 and =65 years of age separately
Timepoint [6] 0 0
4 weeks after vaccination
Secondary outcome [7] 0 0
Difference in percentage of participants achieving seroconversion for each strain between qIRV recipients and QIV recipients, 18 through 64 and =65 years of age separately
Timepoint [7] 0 0
4 weeks after vaccination
Secondary outcome [8] 0 0
HAI geometric mean titers (GMTs) for each strain, 18 through 64 years of age and =65 years of age separately
Timepoint [8] 0 0
4 weeks after vaccination
Secondary outcome [9] 0 0
HAI geometric mean fold rise (GMFR) for each strain, 18 through 64 years of age and =65 years of age separately
Timepoint [9] 0 0
4 weeks after vaccination
Secondary outcome [10] 0 0
The proportion of participants achieving HAI seroconversion for each strain, 18 through 64 years of age and =65 years of age separately
Timepoint [10] 0 0
4 weeks after vaccination
Secondary outcome [11] 0 0
The proportion of participants with HAI titers =1:40 for each strain, 18 through 64 years of age and =65 years of age separately
Timepoint [11] 0 0
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
46169
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Alabama
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Colorado
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Connecticut
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District of Columbia
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Florida
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Idaho
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Wisconsin
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Argentina
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Santa FE
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Argentina
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Tucumán
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Argentina
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Buenos Aires
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Brazil
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Bahia
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Chile
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Región Metropolitana DE Santiago
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BAY OF Plenty
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Canterbury
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Waikato
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Wellington
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Auckland
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Nelson
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Philippines
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Iloilo
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Metro Manila
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National Capital Region
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Philippines
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Palawan
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Cebu
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Dasmarinas City
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Dasmarinas
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Iloilo City
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Manila
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Gauteng
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Soshanguve
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uMzimkhulu

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05540522