Clinical trial NCT05301322: Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE WHEN COADMINISTERED WITH SEASONAL INACTIVATED INFLUENZA VACCINE IN ADULTS ≥65 YEARS OF AGE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus
Keywords: Respiratory tract infection
RSV
vaccine
older adults
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 1471
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety and immunogenicity of RSVpreF when coadministered with SIIV compared to sequential administration of the vaccines when given 1 month apart (SIIV followed by RSVpreF). Additionally, the study will contribute data supporting the development of RSVpreF as a prophylactic vaccine against RSV disease in infants through maternal immunization and in older adults through active vaccination.

Detailed description: This Phase 3, multicenter, parallel-group, placebo-controlled, randomized, double-blind study will be conducted in Australia and/or another southern hemisphere country.

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.

Eligibility criteria: Inclusion Criteria:

1. Male and female participants ≥65 years of age at the time of consent.
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:

1. Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate IM injection.
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

Primary outcomes:
measure: Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo
timeFrame: Within 7 days after Vaccination 1 or Vaccination 2
measure: Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo
timeFrame: Within 7 days after Vaccination 1 or Vaccination 2
measure: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1
timeFrame: Within 1 month after Vaccination 1
measure: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 2
timeFrame: Within 1 month after Vaccination 2
measure: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1
timeFrame: Within 1 month after Vaccination 1
measure: Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 2
timeFrame: Within 1 month after Vaccination 2
measure: Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) at 1 Month After Vaccination With RSVpreF for RSV Subfamily A and B in RSVpreF + SIIV Compared to RSVpreF Alone
timeFrame: 1 month after Vaccination 1 for Coadministration Group and 1 month after Vaccination 2 for Sequential-Administration Group
measure: GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers 1 Month After Vaccination With SIIV in the Coadministration Group to the Corresponding HAI Titers in the Sequential-Administration Group
timeFrame: 1 month after Vaccination 1
Secondary outcomes:
measure: Geometric Mean of the Neutralizing Titers for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF
timeFrame: Coadministration Group: before RSVpreF vaccination, and 1 and 2 months after RSVpreF vaccination; Sequential-Administration Group: before RSVpreF vaccination (most recent serology results before RSVpreF) and 1 month after RSVpreF vaccination
measure: Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF
timeFrame: Coadministration Group: before RSVpreF vaccination, and 1 and 2 months after vaccination; Sequential-Administration Group: before RSVpreF vaccination (most recent serology results before RSVpreF) and 1 month after vaccination
measure: HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV
timeFrame: Before SIIV vaccination, and 1 month after vaccination
measure: GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV
timeFrame: Before SIIV vaccination, and 1 month after vaccination
Other outcomes:
Locations:
city: Bruce
country: Australia
facility: Paratus Clinical Research Canberra
state: Australian Capital Territory
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney
state: New South Wales
city: Botany
country: Australia
facility: Emeritus Research
state: New South Wales
city: Broadmeadow
country: Australia
facility: Genesis Research Services
state: New South Wales
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Northside Health
state: New South Wales
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical Research Central Coast
state: New South Wales
city: Merewether
country: Australia
facility: The AIM Centre / Hunter Diabetes Centre
state: New South Wales
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Scientia Clinical Research
state: New South Wales
city: Sydney
country: Australia
facility: Australian Clinical Research Network
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Albion
country: Australia
facility: Paratus Clinical Research Brisbane
state: Queensland
city: Brisbane
country: Australia
facility: Core Research Group
state: Queensland
city: Gold Coast Campus
country: Australia
facility: Griffith University
state: Queensland
city: Herston
country: Australia
facility: Nucleus Network Brisbane
state: Queensland
city: Mackay
country: Australia
facility: Mackay Hospital and Health Service
state: Queensland
city: Morayfield
country: Australia
facility: USC Clinical Trials Moreton Bay
state: Queensland
city: Sippy Downs
country: Australia
facility: USC Clinical Trials Centre
state: Queensland
city: Taringa
country: Australia
facility: AusTrials - Taringa
state: Queensland
city: Taringa
country: Australia
facility: Core Research Group
state: Queensland
city: Tarragindi
country: Australia
facility: AusTrials Wellers Hill
state: Queensland
city: Adelaide
country: Australia
facility: CMAX Clinical Research Pty Ltd
state: South Australia
city: Hobart
country: Australia
facility: University of Tasmania
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Ivanhoe
country: Australia
facility: Doctors of Ivanhoe
state: Victoria
city: Melbourne
country: Australia
facility: Nucleus Network Brisbane
state: Victoria
city: Melbourne
country: Australia
facility: Nucleus Network Melbourne
state: Victoria
city: Nedlands
country: Australia
facility: Institute for Respiratory Health
state: Western Australia
city: Spearwood
country: Australia
facility: Latitude Clinical Research
state: Western Australia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: