Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age
NCT ID: NCT05301322
Last Updated: 2023-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1471 participants
INTERVENTIONAL
2022-04-13
2022-10-12
Brief Summary
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Detailed Description
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Healthy adults ≥65 years of age will be randomized 1:1 to either the coadministration group (RSVpreF + SIIV)/placebo or the sequential-administration group (placebo + SIIV)/RSVpreF. This study design intends to use a single lot of NIP SIIV that is specifically indicated for use in adults ≥65 years of age.
There are 3 scheduled study visits each 1 month apart. To assess immunogenicity, 30 mL blood will be collected prior to vaccination at Visit 1 and Visit 2, and at Visit 3.
Local reactions (redness, swelling, and pain at the injection site) occurring at the RSVpreF or placebo injection site (left deltoid) and systemic events (fever, headache, fatigue, nausea, vomiting, diarrhea, muscle pain, and joint pain) occurring within 7 days after each vaccination visit (Visit 1 and Visit 2) will be prompted for and collected daily by the participant in an e-diary device or smartphone app. SIIV injection site reactions will not be routinely collected in the e-diary.
AEs and SAEs will be collected from the signing of informed consent through Visit 3.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
The participant, study coordinator, and all site staff will be blinded.
The majority of sponsor staff will be blinded to study intervention allocation. All laboratory testing personnel performing serological assays or diagnostic assays will remain blinded to the study intervention assigned/received throughout the study.
Study Groups
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Coadministration Group
RSVpreF and SIIV followed by placebo a month later
RSVpreF Vaccine
RSV Vaccine
Placebo
Placebo
Seasonal Inactivated Influenza Vaccine
SIIV
Sequential Administration Group
Placebo and SIIV followed by RSVpreF a month later
RSVpreF Vaccine
RSV Vaccine
Placebo
Placebo
Seasonal Inactivated Influenza Vaccine
SIIV
Interventions
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RSVpreF Vaccine
RSV Vaccine
Placebo
Placebo
Seasonal Inactivated Influenza Vaccine
SIIV
Eligibility Criteria
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Inclusion Criteria
2. Participants who are willing and able to comply with scheduled visits, laboratory tests, lifestyle considerations, and other study procedures, including daily completion of the e diary for 7 days after each study vaccination.
3. Healthy participants who are determined by medical history, physical examination and clinical judgment of the investigator to be eligible for inclusion in the study.
4. Capable of giving signed informed consent
Exclusion Criteria
2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.
3. Allergy to egg proteins (egg or egg products) or chicken proteins.
4. History of Guillain-Barré syndrome.
5. Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
6. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
7. Other 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.
8. Previous vaccination with any licensed or investigational RSV vaccine at any time prior to enrollment, or planned receipt throughout the study of nonstudy RSV vaccine.
9. Previous vaccination with any influenza vaccine within 6 months before study intervention administration, or planned receipt of any nonstudy licensed or investigational influenza vaccine during study participation.
10. Receipt of any blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study.
11. Individuals who receive chronic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids (\<20 mg/day of prednisone or equivalent) have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroid use is permitted.
12. Current alcohol abuse or illicit drug use.
13. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s)
14. Participation in other studies involving investigational product(s) within 28 days prior to consent and/or during study participation
15. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members
65 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Paratus Clinical Research Canberra
Bruce, Australian Capital Territory, Australia
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
Emeritus Research
Botany, New South Wales, Australia
Genesis Research Services
Broadmeadow, New South Wales, Australia
Northern Beaches Clinical Research
Brookvale, New South Wales, Australia
Northside Health
Coffs Harbour, New South Wales, Australia
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
The AIM Centre / Hunter Diabetes Centre
Merewether, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Scientia Clinical Research
Randwick, New South Wales, Australia
Australian Clinical Research Network
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Paratus Clinical Research Brisbane
Albion, Queensland, Australia
Core Research Group
Brisbane, Queensland, Australia
Griffith University
Gold Coast Campus, Queensland, Australia
Nucleus Network Brisbane
Herston, Queensland, Australia
Mackay Hospital and Health Service
Mackay, Queensland, Australia
USC Clinical Trials Moreton Bay
Morayfield, Queensland, Australia
USC Clinical Trials Centre
Sippy Downs, Queensland, Australia
AusTrials - Taringa
Taringa, Queensland, Australia
Core Research Group
Taringa, Queensland, Australia
AusTrials Wellers Hill
Tarragindi, Queensland, Australia
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
University of Tasmania
Hobart, Tasmania, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Emeritus Research
Camberwell, Victoria, Australia
Barwon Health
Geelong, Victoria, Australia
Doctors of Ivanhoe
Ivanhoe, Victoria, Australia
Nucleus Network Brisbane
Melbourne, Victoria, Australia
Nucleus Network Melbourne
Melbourne, Victoria, Australia
Institute for Respiratory Health
Nedlands, Western Australia, Australia
Latitude Clinical Research
Spearwood, Western Australia, Australia
Countries
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References
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Athan E, Baber J, Quan K, Scott RJ, Jaques A, Jiang Q, Li W, Cooper D, Cutler MW, Kalinina EV, Anderson AS, Swanson KA, Gruber WC, Gurtman A, Schmoele-Thoma B; Study C3671006 Investigator Group. Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults. Clin Infect Dis. 2024 May 15;78(5):1360-1368. doi: 10.1093/cid/ciad707.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C3671006
Identifier Type: -
Identifier Source: org_study_id
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