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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05301322




Registration number
NCT05301322
Ethics application status
Date submitted
2/03/2022
Date registered
29/03/2022

Titles & IDs
Public title
Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults =65 Years of Age
Scientific 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
Secondary ID [1] 0 0
C3671006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - RSVpreF Vaccine
Other interventions - Placebo
Treatment: Other - Seasonal Inactivated Influenza Vaccine

Experimental: Coadministration Group - RSVpreF and SIIV followed by placebo a month later

Experimental: Sequential Administration Group - Placebo and SIIV followed by RSVpreF a month later


Treatment: Other: RSVpreF Vaccine
RSV Vaccine

Other interventions: Placebo
Placebo

Treatment: Other: Seasonal Inactivated Influenza Vaccine
SIIV
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo
Timepoint [1] 0 0
Within 7 days after Vaccination 1 or Vaccination 2
Primary outcome [2] 0 0
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo
Timepoint [2] 0 0
Within 7 days after Vaccination 1 or Vaccination 2
Primary outcome [3] 0 0
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1
Timepoint [3] 0 0
Within 1 month after Vaccination 1
Primary outcome [4] 0 0
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 2
Timepoint [4] 0 0
Within 1 month after Vaccination 2
Primary outcome [5] 0 0
Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1
Timepoint [5] 0 0
Within 1 month after Vaccination 1
Primary outcome [6] 0 0
Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 2
Timepoint [6] 0 0
Within 1 month after Vaccination 2
Primary outcome [7] 0 0
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
Timepoint [7] 0 0
1 month after Vaccination 1 for Coadministration Group and 1 month after Vaccination 2 for Sequential-Administration Group
Primary outcome [8] 0 0
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
Timepoint [8] 0 0
1 month after Vaccination 1
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV
Timepoint [3] 0 0
Before SIIV vaccination, and 1 month after vaccination
Secondary outcome [4] 0 0
GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV
Timepoint [4] 0 0
Before SIIV vaccination, and 1 month after vaccination

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

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
13/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/10/2022
Sample size
Target
Accrual to date
Final
1471
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Paratus Clinical Research Canberra - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [3] 0 0
Emeritus Research - Botany
Recruitment hospital [4] 0 0
Genesis Research Services - Broadmeadow
Recruitment hospital [5] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [6] 0 0
Northside Health - Coffs Harbour
Recruitment hospital [7] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment hospital [8] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [9] 0 0
The AIM Centre / Hunter Diabetes Centre - Merewether
Recruitment hospital [10] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [11] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [12] 0 0
Australian Clinical Research Network - Sydney
Recruitment hospital [13] 0 0
Westmead Hospital - Westmead
Recruitment hospital [14] 0 0
Paratus Clinical Research Brisbane - Albion
Recruitment hospital [15] 0 0
Core Research Group - Brisbane
Recruitment hospital [16] 0 0
Griffith University - Gold Coast Campus
Recruitment hospital [17] 0 0
Nucleus Network Brisbane - Herston
Recruitment hospital [18] 0 0
Mackay Hospital and Health Service - Mackay
Recruitment hospital [19] 0 0
USC Clinical Trials Moreton Bay - Morayfield
Recruitment hospital [20] 0 0
USC Clinical Trials Centre - Sippy Downs
Recruitment hospital [21] 0 0
AusTrials - Taringa - Taringa
Recruitment hospital [22] 0 0
Core Research Group - Taringa
Recruitment hospital [23] 0 0
AusTrials Wellers Hill - Tarragindi
Recruitment hospital [24] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment hospital [25] 0 0
University of Tasmania - Hobart
Recruitment hospital [26] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [27] 0 0
Emeritus Research - Camberwell
Recruitment hospital [28] 0 0
Barwon Health - Geelong
Recruitment hospital [29] 0 0
Doctors of Ivanhoe - Ivanhoe
Recruitment hospital [30] 0 0
Nucleus Network Brisbane - Melbourne
Recruitment hospital [31] 0 0
Nucleus Network Melbourne - Melbourne
Recruitment hospital [32] 0 0
Institute for Respiratory Health - Nedlands
Recruitment hospital [33] 0 0
Latitude Clinical Research - Spearwood
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2019 - Botany
Recruitment postcode(s) [4] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [5] 0 0
2100 - Brookvale
Recruitment postcode(s) [6] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [7] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [8] 0 0
2259 - Kanwal
Recruitment postcode(s) [9] 0 0
2291 - Merewether
Recruitment postcode(s) [10] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [11] 0 0
2031 - Randwick
Recruitment postcode(s) [12] 0 0
NSW 2035 - Sydney
Recruitment postcode(s) [13] 0 0
2145 - Westmead
Recruitment postcode(s) [14] 0 0
4010 - Albion
Recruitment postcode(s) [15] 0 0
4064 - Brisbane
Recruitment postcode(s) [16] 0 0
4222 - Gold Coast Campus
Recruitment postcode(s) [17] 0 0
4006 - Herston
Recruitment postcode(s) [18] 0 0
4740 - Mackay
Recruitment postcode(s) [19] 0 0
4506 - Morayfield
Recruitment postcode(s) [20] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [21] 0 0
4068 - Taringa
Recruitment postcode(s) [22] 0 0
4121 - Tarragindi
Recruitment postcode(s) [23] 0 0
5000 - Adelaide
Recruitment postcode(s) [24] 0 0
7000 - Hobart
Recruitment postcode(s) [25] 0 0
3128 - Box Hill
Recruitment postcode(s) [26] 0 0
3124 - Camberwell
Recruitment postcode(s) [27] 0 0
3220 - Geelong
Recruitment postcode(s) [28] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [29] 0 0
3004 - Melbourne
Recruitment postcode(s) [30] 0 0
6009 - Nedlands
Recruitment postcode(s) [31] 0 0
6163 - Spearwood

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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05301322