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

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05540522

Collaborator

(none)

25,000

Enrollment

Locations

Arms

9.1

Anticipated Duration (Months)

268.8

Patients Per Site

29.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza, Human	Biological: Quadrivalent influenza modRNA vaccine Biological: Quadrivalent influenza vaccine	Phase 3

Detailed Description

This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 seasonally recommended strains (2 A strains and 2 B strains) compared to licensed quadrivalent influenza vaccine (QIV) in healthy adults 18 years of age and older.

Participants may be enrolled in either the reactogenicity subset, immunogenicity subset, or both subsets. Efficacy will be assessed in this study through surveillance for influenza-like illness.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official 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

Actual Study Start Date :

Sep 12, 2022

Anticipated Primary Completion Date :

Jun 16, 2023

Anticipated Study Completion Date :

Jun 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quadrivalent influenza modRNA vaccine, 18 through 64 years of age Quadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age	Biological: Quadrivalent influenza modRNA vaccine Quadrivalent influenza modRNA vaccine (single dose)
Active Comparator: Quadrivalent influenza vaccine, 18 through 64 years of age Licensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age	Biological: Quadrivalent influenza vaccine Licensed quadrivalent influenza vaccine (single dose)
Experimental: Quadrivalent influenza modRNA vaccine, ≥65 years of age Quadrivalent influenza modRNA vaccine (single dose), participants ≥65 years of age	Biological: Quadrivalent influenza modRNA vaccine Quadrivalent influenza modRNA vaccine (single dose)
Active Comparator: Quadrivalent influenza vaccine, ≥65 years of age Licensed quadrivalent influenza vaccine (single dose), participants ≥65 years of age	Biological: Quadrivalent influenza vaccine Licensed quadrivalent influenza vaccine (single dose)

Outcome Measures

Primary Outcome Measures

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 and ≥65 years of age combined [At least 14 days after vaccination]
As measured at the central laboratory
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 [4 weeks after vaccination]
As measured at the central laboratory
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 [4 weeks after vaccination]
As measured at the central laboratory
Percentage of participants reporting local reactions, 18 through 64 years of age and ≥65 years of age separately and combined [For up to 7 days following vaccination]
Pain at the injection site, redness, and swelling
Percentage of participants reporting systemic events, 18 through 64 years of age and ≥65 years of age separately and combined [For up to 7 days following vaccination]
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain
Percentage of participants reporting adverse events, 18 through 64 years of age and ≥65 years of age separately and combined [From the time the participant provides informed consent through 4 weeks after vaccination]
As elicited by investigational site staff
Percentage of participants reporting serious adverse events, 18 through 64 years of age and ≥65 years of age separately and combined [From the time the participant provides informed consent through 6 months after vaccination]
As elicited by investigational site staff

Secondary Outcome Measures

GMR of HAI titers for each A strain in qIRV recipients compared to QIV recipients, 18 through 64 years of age and ≥65 years of age separately [4 weeks after vaccination]
As measured at the central laboratory
Difference in percentage achieving seroconversion for each A strain between qIRV recipients and QIV recipients, 18 through 64 and ≥65 years of age separately [4 weeks after vaccination]
As measured at the central laboratory
HAI geometric mean titers (GMTs) for each strain, 18 through 64 years of age and ≥65 years of age separately [At 4 weeks and 6 months after vaccination]
As measured at the central laboratory
HAI geometric mean fold rise (GMFR) for each strain, 18 through 64 years of age and ≥65 years of age separately [Before vaccination and at 4 weeks and 6 months after vaccination]
As measured at the central laboratory
The proportion of participants achieving HAI seroconversion for each strain, 18 through 64 years of age and ≥65 years of age separately [At 4 weeks and 6 months after vaccination]
As measured at the central laboratory
The proportion of participants with HAI titers ≥1:40 for each strain, 18 through 64 years of age and ≥65 years of age separately [Before vaccination and at 4 weeks and 6 months after vaccination]
As measured at the central laboratory
The proportion of participants achieving HAI seroconversion for all strains, 18 through 64 years of age and ≥65 years of age separately [At 4 weeks and 6 months after vaccination]
As measured at the central laboratory
The proportion of participants with HAI titers ≥1:40 for all strains, 18 through 64 years of age and ≥65 years of age separately [Before vaccination and at 4 weeks and 6 months after vaccination]
As measured at the central laboratory
The proportion of participants reporting LCI cases with associated per-protocol ILI in each vaccine group, ≥65 years of age [At least 14 days after vaccination]
As measured at the central laboratory
The proportion of participants reporting LCI cases with associated per-protocol ILI in each vaccine group, 18 through 64 years of age [At least 14 days after vaccination]
As measured at the central laboratory
The proportion of participants reporting LCI cases with associated per-protocol ILI caused by all matched strains or each matched strain in each vaccine group, 18 through 64 years of age and ≥65 years of age separately and combined [At least 14 days after vaccination]
As measured at the central laboratory
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 and combined [At least 14 days after vaccination]
As measured at the central laboratory
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 and combined [At least 14 days after vaccination]
As measured at the central laboratory
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 and combined [At least 14 days after vaccination]
As measured at the central laboratory
The proportion of participants reporting cases of influenza, as confirmed by 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 and combined [At least 14 days after vaccination]
As measured at the central laboratory

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male or female participants ≥18 years of age at Visit 1 (Day 1).
Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
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.
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.

Exclusion Criteria:

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.
History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
Allergy to egg proteins (egg or egg products) or chicken proteins.
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.
Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration.
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.
Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in this study.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Alabama Research Center	Athens	Alabama	United States	35611
2	Medical Affiliated Research Center	Huntsville	Alabama	United States	35801
3	Lenzmeier Family Medicine/CCT Research	Glendale	Arizona	United States	85308
4	Hope Research Institute	Phoenix	Arizona	United States	85018
5	The Pain Center of Arizona	Phoenix	Arizona	United States	85018
6	HOPE Research Institute - Phoenix	Phoenix	Arizona	United States	85023
7	HOPE Research Institute	Phoenix	Arizona	United States	85023
8	Foothills Research Center/ CCT Research	Phoenix	Arizona	United States	85044
9	HOPE Research Institute - Tempe	Tempe	Arizona	United States	85284
10	Noble Clinical Research	Tucson	Arizona	United States	85704
11	Velocity Clinical Research, Banning	Banning	California	United States	92220
12	Kaiser Permanente	Los Angeles	California	United States	90027
13	Velocity Clinical Research, Westlake.	Los Angeles	California	United States	90057
14	Velocity Clinical Research, Westlake	Los Angeles	California	United States	90057
15	Velocity Clinical Research, North Hollywood	North Hollywood	California	United States	91606
16	Center for Clinical Trials, LLC	Paramount	California	United States	90723
17	Paradigm Clinical Research Centers, Inc	Redding	California	United States	96001
18	Peninsula Research Associates	Rolling Hills Estates	California	United States	90274
19	Benchmark Research	Sacramento	California	United States	95864
20	Wr-McCr, Llc	San Diego	California	United States	92120
21	California Research Foundation	San Diego	California	United States	92123
22	Encompass Clinical Research	Spring Valley	California	United States	91978
23	Orange County Research Center	Tustin	California	United States	92780
24	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
25	Lynn Institute of Denver	Aurora	Colorado	United States	80012
26	Paradigm Clinical Research Centers, Inc	Wheat Ridge	Colorado	United States	80033
27	Clinical Research Consulting	Milford	Connecticut	United States	06460
28	Universal Axon Clinical Research, LLC	Doral	Florida	United States	33166
29	Fleming Island Center for Clinical Research	Fleming Island	Florida	United States	32003
30	Best Quality Research,Inc.	Hialeah	Florida	United States	33016
31	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
32	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Jacksonville	Florida	United States	32256
33	Health Awareness	Jupiter	Florida	United States	33458
34	Wr-Msra.Llc	Lake City	Florida	United States	32055
35	Clinical Neuroscience Solutions	Orlando	Florida	United States	32801
36	IACT Health	Columbus	Georgia	United States	31904
37	Meridian Clinical Research, LLC	Savannah	Georgia	United States	31406
38	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
39	East-West Medical Research Institute	Honolulu	Hawaii	United States	96814
40	Solaris Clinical Research	Meridian	Idaho	United States	83646
41	Accellacare - DuPage	Oak Lawn	Illinois	United States	60453
42	Meridian Clinical Research, LLC	Sioux City	Iowa	United States	51106
43	Clinical Research Professionals	Chesterfield	Missouri	United States	63005
44	Sundance Clinical Research	Saint Louis	Missouri	United States	63141
45	Meridian Clinical Research, LLC.	Grand Island	Nebraska	United States	68803
46	Meridian Clinical Research, LLC	Grand Island	Nebraska	United States	68803
47	Meridian Clinical Research, LLC	Norfolk	Nebraska	United States	68701
48	Meridian Clinical Research - 3345 North 107th Street	Omaha	Nebraska	United States	68134
49	Meridian Clinical Research, LLC	Omaha	Nebraska	United States	68134
50	Meridian Clinical Research, LLC	Endwell	New York	United States	13760
51	NYU Langone Health	New York	New York	United States	10016
52	Accellacare - Charlotte	Charlotte	North Carolina	United States	28209
53	PharmQuest Life Sciences, LLC	Greensboro	North Carolina	United States	27408
54	Accellacare - Hickory	Hickory	North Carolina	United States	28601
55	M3 Wake Research Associates	Raleigh	North Carolina	United States	27612
56	Accellacare - Rocky Mount	Rocky Mount	North Carolina	United States	27804
57	Accellacare - Salisbury	Salisbury	North Carolina	United States	28144
58	Accellacare - Wilmington	Wilmington	North Carolina	United States	28401
59	Trial Management Associates - Wilmington - Floral Parkway	Wilmington	North Carolina	United States	28403
60	CTI Clinical Research Center	Cincinnati	Ohio	United States	45212
61	Meridian Clinical Research, LLC	Cincinnati	Ohio	United States	45219
62	Velocity Clinical Research, Cleveland	Cleveland	Ohio	United States	44122
63	Dayton Clinical Research	Dayton	Ohio	United States	45409
64	Lynn Institute of Norman	Norman	Oklahoma	United States	73072
65	Tekton Research	Yukon	Oklahoma	United States	73099
66	Velocity Clinical Research, Medford	Medford	Oregon	United States	97504
67	Velocity Clinical Research, Providence	East Greenwich	Rhode Island	United States	02818
68	Main Street Physician's Care	Little River	South Carolina	United States	29566
69	Trial Management Associates	Myrtle Beach	South Carolina	United States	29572
70	Coastal Carolina Research Center	North Charleston	South Carolina	United States	29405
71	Accellacare - Bristol	Bristol	Tennessee	United States	37620
72	PMG Research of Bristol, LLC	Bristol	Tennessee	United States	37620
73	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Memphis	Tennessee	United States	38119
74	Benchmark Research	Austin	Texas	United States	78705
75	Tekton Research, Inc.	Austin	Texas	United States	78745
76	Headlands Research - Brownsville	Brownsville	Texas	United States	78526
77	WR-Global Medical Research, LLC	Dallas	Texas	United States	75224
78	DFW Clinical Research	Dallas	Texas	United States	75234
79	Benchmark Research	Fort Worth	Texas	United States	76135
80	Texas Center for Drug Development, Inc.	Houston	Texas	United States	77081
81	SMS Clinical Research	Mesquite	Texas	United States	75149
82	IMA Clinical Research San Antonio	San Antonio	Texas	United States	78229
83	Tekton Research - Fredericksburg Road	San Antonio	Texas	United States	78229
84	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah	United States	84109
85	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah	United States	84121
86	J. Lewis Research, Inc. / Jordan River Family Medicine	South Jordan	Utah	United States	84095
87	Velocity Clinical Research, Salt Lake City	West Jordan	Utah	United States	84088
88	Clinical Alliance for Research and Education - Infectious Diseases (CARE-ID), LLC	Annandale	Virginia	United States	22003
89	Charlottesville Medical Research	Charlottesville	Virginia	United States	22911
90	Virginia Research Center	Midlothian	Virginia	United States	23114
91	Health Research of Hampton Roads, Inc.	Newport News	Virginia	United States	23606
92	Meridian Clinical Research - Portsmouth	Portsmouth	Virginia	United States	23703
93	Allegiance Research Specialists, LLC	Wauwatosa	Wisconsin	United States	53226