Respiratory Syncytial VirusPhase 3NCT05301322

Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age

A Phase 3 study testing RSVpreF Vaccine and Seasonal Inactivated Influenza Vaccine in people with Respiratory Syncytial Virus, run by Pfizer at 33 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Respiratory Syncytial Virus
What is being tested?: RSVpreF Vaccine and Seasonal Inactivated Influenza Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,471 participants
Where: 33 sitesAustralia
Study dates: 13 Apr 2022to 12 Oct 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Male and female participants ≥65 years of age at the time of consent.
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.
Healthy participants who are determined by medical history, physical examination and clinical judgment of the investigator to be eligible for inclusion in the study.
Capable of giving signed informed consent

Who cannot join

Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate IM injection.
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.
Allergy to egg proteins (egg or egg products) or chicken proteins.
History of Guillain-Barré syndrome.
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.
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

Show all 15Show fewer

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.
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.
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.
Receipt of any blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study.
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.
Current alcohol abuse or illicit drug use.
Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s)
Participation in other studies involving investigational product(s) within 28 days prior to consent and/or during study participation
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

Trial locations and contacts

33 sites in 1 country.

City, postcode or hospital

33 sites in 1 country

Australia33 sites

CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000
Paratus Clinical Research Brisbane
Albion, Queensland, 4010
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, 2148
Emeritus Research
Botany, New South Wales, 2019
Box Hill Hospital
Box Hill, Victoria, 3128
Core Research Group
Brisbane, Queensland, 4064
Genesis Research Services
Broadmeadow, New South Wales, 2292
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100
Paratus Clinical Research Canberra
Bruce, Australian Capital Territory, 2617
Emeritus Research
Camberwell, Victoria, 3124
Northside Health
Coffs Harbour, New South Wales, 2450
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010
Barwon Health
Geelong, Victoria, 3220
Griffith University
Gold Coast Campus, Queensland, 4222
Nucleus Network Brisbane
Herston, Queensland, 4006
University of Tasmania
Hobart, Tasmania, 7000
Doctors of Ivanhoe
Ivanhoe, Victoria, 3079
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259
Mackay Hospital and Health Service
Mackay, Queensland, 4740
Nucleus Network Brisbane
Melbourne, Victoria, 3004
Nucleus Network Melbourne
Melbourne, Victoria, 3004
The AIM Centre / Hunter Diabetes Centre
Merewether, New South Wales, 2291
USC Clinical Trials Moreton Bay
Morayfield, Queensland, 4506
Institute for Respiratory Health
Nedlands, Western Australia, 6009
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Scientia Clinical Research
Randwick, New South Wales, 2031
USC Clinical Trials Centre
Sippy Downs, Queensland, 4556
Latitude Clinical Research
Spearwood, Western Australia, 6163
Australian Clinical Research Network
Sydney, New South Wales, NSW 2035
AusTrials - Taringa
Taringa, Queensland, 4068
Core Research Group
Taringa, Queensland, 4068
AusTrials Wellers Hill
Tarragindi, Queensland, 4121
Westmead Hospital
Westmead, New South Wales, 2145

Other trials in Australia

About this study

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

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.

Read the 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.

Conditions: Respiratory Syncytial Virus
Being tested: RSVpreF Vaccine, Placebo, Seasonal Inactivated Influenza Vaccine
Keywords: Respiratory tract infection, RSV, vaccine, older adults
Medical subject headings: Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RSVpreF VaccineBiological
RSV Vaccine
PlaceboOther
Placebo
Seasonal Inactivated Influenza VaccineBiological
SIIV

Study groups in NCT05301322
Study group	Role	What they receive
Coadministration Group	Experimental	RSVpreF and SIIV followed by placebo a month later Receives: Biological: RSVpreF Vaccine; Other: Placebo; Biological: Seasonal Inactivated Influenza Vaccine
Sequential Administration Group	Experimental	Placebo and SIIV followed by RSVpreF a month later Receives: Biological: RSVpreF Vaccine; Other: Placebo; Biological: Seasonal Inactivated Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo
Local reactions were collected at the RSVpreF or placebo injection site after Vaccination 1 and Vaccination 2 and were recorded by participants using electronic diary (e-diary). Local reactions included redness, swelling and pain at injection site. Redness and swelling were measured and recorded in measuring device units where, 1 measuring device unit =0.5 centimeter (cm) and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Percentage of participants reporting local reactions at injection site in Coadministration Group, and Sequential-Administration Group and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented in this outcome measure (OM). Safety population=all enrolled participants who received study intervention (RSVpreF, placebo).
Measured: Within 7 days after Vaccination 1 or Vaccination 2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo
Systemic events included fever, fatigue, headache, nausea, vomiting, diarrhea, muscle pain and joint pain and were recorded by participants using an e-diary. Fever was defined as an oral temperature >=38.0 degree Celsius (deg C) and categorized as >=38.0 to 38.4 deg C (mild), >38.4 to 38.9 deg C (moderate), >38.9 to 40.0 deg C (severe) and >40.0 deg C (grade 4). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Vomiting was graded mild: 1 to 2 times in 24 hours (h), moderate: >2 times in 24h, and severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Percentage of participants with systemic events within 7 days after each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Measured: Within 7 days after Vaccination 1 or Vaccination 2
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 1 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Measured: Within 1 month after Vaccination 1
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 2
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Measured: Within 1 month after Vaccination 2
Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1
An SAE was defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Percentage of participants reporting SAEs within 1 month after Vaccination 1 were reported in this outcome measure.
Measured: Within 1 month after Vaccination 1
Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 2
An SAE was defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Percentage of participants reporting SAEs within 1 month after Vaccination 2 were reported in this outcome measure.
Measured: Within 1 month after Vaccination 2
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
Geometric mean titer (GMT) of RSV A and RSV B neutralizing titers for the Coadministration Group and Sequential-Administration Group were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CI were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5*LLOQ. Geometric mean ratio (GMR) was reported in the statistical analysis section and was calculated as ratio of GMTs in the Coadministration Group to the Sequential-Administration Group.
Measured: 1 month after Vaccination 1 for Coadministration Group and 1 month after Vaccination 2 for Sequential-Administration Group
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
GMTs of strain-specific HAI titers for the Coadministration Group and Sequential-Administration Group were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section and was calculated as ratio of GMT in the Coadministration Group to the Sequential-Administration Group.
Measured: 1 month after Vaccination 1

Secondary outcomes (4)

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
GMT of neutralizing titers of RSV A and RSV B before vaccination, at 1 month and 2 months after vaccination was reported in this outcome measure. Assay results below the LLOQ were set to 0.5*LLOQ. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). For Sequential-Administration Group, the time point for 2 months after vaccination was not reported since the participants received RSVpreF at Vaccination 2 and were followed up for 1 month after Vaccination 2.
Measured: 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
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
GMFR of neutralizing titers of RSV A and RSV B before vaccination and at 1 month and 2 months after vaccination was reported in this outcome measure. GMFR and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the fold rises from before vaccination and the corresponding CIs (based on the Student's t distribution).
Measured: 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
HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV
HAI GMT before vaccination and 1 month after vaccination with SIIV was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution).
Measured: Before SIIV vaccination, and 1 month after vaccination
GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV
GMFR of strain-specific HAI titers before vaccination and 1 month after vaccination with SIIV was reported in this outcome measure. GMFRs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of fold rises (later time point over earlier time point) and the corresponding CIs (based on Student's t distribution).
Measured: Before SIIV vaccination, and 1 month after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 202212 Oct 2022

First posted29 Mar 2022
Study start13 Apr 2022
Primary completion12 Oct 2022
Study completion12 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,471 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05301322
Sponsor's protocol ID: C3671006
Status last verified: Oct 2023
First submitted: 2 Mar 2022
Last updated: 27 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 37992000

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization

All Respiratory Syncytial Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05301322
Acronym / sponsor ID: C3671006
Conditions: Respiratory Syncytial Virus
Keywords: Respiratory tract infection, RSV, vaccine, older adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,471 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 13 Apr 2022 (actual)
Primary completion: 12 Oct 2022 (actual)
Study completion: 12 Oct 2022 (actual)
First posted: 29 Mar 2022 (actual)
Results: Posted 27 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

AEs and SAEs will be collected from the signing of informed consent through Visit 3.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Parallel

Arm	Type	Receives
Coadministration Group	Experimental	Biological: RSVpreF Vaccine, Other: Placebo, Biological: Seasonal Inactivated Influenza VaccineRSVpreF and SIIV followed by placebo a month later
Sequential Administration Group	Experimental	Biological: RSVpreF Vaccine, Other: Placebo, Biological: Seasonal Inactivated Influenza VaccinePlacebo and SIIV followed by RSVpreF a month later

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (4 listed)

Male and female participants ≥65 years of age at the time of consent.
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.
Healthy participants who are determined by medical history, physical examination and clinical judgment of the investigator to be eligible for inclusion in the study.
Capable of giving signed informed consent

Key exclusion criteria (15 listed)

Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate IM injection.
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.
Allergy to egg proteins (egg or egg products) or chicken proteins.
History of Guillain-Barré syndrome.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RSVpreF VaccineRSV Vaccine	Biological	Coadministration Group, Sequential Administration Group
PlaceboPlacebo	Other	Coadministration Group, Sequential Administration Group
Seasonal Inactivated Influenza VaccineSIIV	Biological	Coadministration Group, Sequential Administration Group

Primary outcome

Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo
Time frame: Within 7 days after Vaccination 1 or Vaccination 2
Local reactions were collected at the RSVpreF or placebo injection site after Vaccination 1 and Vaccination 2 and were recorded by participants using electronic diary (e-diary). Local reactions included redness, swelling and pain at injection site. Redness and swelling were measured and recorded in measuring device units where, 1 measuring device unit =0.5 centimeter (cm) and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Percentage of participants reporting local reactions at injection site in Coadministration Group, and Sequential-Administration Group and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented in this outcome measure (OM). Safety population=all enrolled participants who received study intervention (RSVpreF, placebo).
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo
Time frame: Within 7 days after Vaccination 1 or Vaccination 2
Systemic events included fever, fatigue, headache, nausea, vomiting, diarrhea, muscle pain and joint pain and were recorded by participants using an e-diary. Fever was defined as an oral temperature >=38.0 degree Celsius (deg C) and categorized as >=38.0 to 38.4 deg C (mild), >38.4 to 38.9 deg C (moderate), >38.9 to 40.0 deg C (severe) and >40.0 deg C (grade 4). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Vomiting was graded mild: 1 to 2 times in 24 hours (h), moderate: >2 times in 24h, and severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Percentage of participants with systemic events within 7 days after each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1
Time frame: Within 1 month after Vaccination 1
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 1 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 2
Time frame: Within 1 month after Vaccination 2
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1
Time frame: Within 1 month after Vaccination 1
An SAE was defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Percentage of participants reporting SAEs within 1 month after Vaccination 1 were reported in this outcome measure.
Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 2
Time frame: Within 1 month after Vaccination 2
An SAE was defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Percentage of participants reporting SAEs within 1 month after Vaccination 2 were reported in this outcome 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
Time frame: 1 month after Vaccination 1 for Coadministration Group and 1 month after Vaccination 2 for Sequential-Administration Group
Geometric mean titer (GMT) of RSV A and RSV B neutralizing titers for the Coadministration Group and Sequential-Administration Group were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CI were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5*LLOQ. Geometric mean ratio (GMR) was reported in the statistical analysis section and was calculated as ratio of GMTs in the Coadministration Group to the Sequential-Administration Group.
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
Time frame: 1 month after Vaccination 1
GMTs of strain-specific HAI titers for the Coadministration Group and Sequential-Administration Group were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. GMR was reported in the statistical analysis section and was calculated as ratio of GMT in the Coadministration Group to the Sequential-Administration Group.

4 secondary outcomes

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
Time frame: 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
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
Time frame: 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
HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV
Time frame: Before SIIV vaccination, and 1 month after vaccination
GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV
Time frame: Before SIIV vaccination, and 1 month after vaccination

Results and safety

Results posted to the registry on 27 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
(RSVpreF + SIIV)/Placebo: Coadministration Group	705	686
(Placebo + SIIV)/RSVpreF: Sequential-Administration Group	698	692

Primary outcome: Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo

Time frame: Within 7 days after Vaccination 1 or Vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	RSVpreF + SIIV: Coadministration Group n = 701	Placebo: Coadministration Group n = 681	Placebo + SIIV: Sequential-Administration Group n = 693	RSVpreF: Sequential-Administration Group n = 686
Pain at injection site: Mild	10.1 (8.0 to 12.6)	6.5 (4.7 to 8.6)	7.6 (5.8 to 9.9)	11.5 (9.2 to 14.1)
Pain at injection site: Moderate	1.3 (0.6 to 2.4)	0.9 (0.3 to 1.9)	0.7 (0.2 to 1.7)	0.9 (0.3 to 1.9)
Pain at injection site: Severe	0 (0.0 to 0.5)	0 (0.0 to 0.5)	0 (0.0 to 0.5)	0 (0.0 to 0.5)
Redness: Mild	2.1 (1.2 to 3.5)	0.3 (0.0 to 1.1)	0.6 (0.2 to 1.5)	0.7 (0.2 to 1.7)
Redness: Moderate	0.9 (0.3 to 1.9)	0.1 (0.0 to 0.8)	0.1 (0.0 to 0.8)	0.9 (0.3 to 1.9)
Redness: Severe	0 (0.0 to 0.5)	0 (0.0 to 0.5)	0 (0.0 to 0.5)	0 (0.0 to 0.5)
Swelling: Mild	1.6 (0.8 to 2.8)	0.3 (0.0 to 1.1)	0.1 (0.0 to 0.8)	1.2 (0.5 to 2.3)
Swelling: Moderate	1.3 (0.6 to 2.4)	0 (0.0 to 0.5)	0 (0.0 to 0.5)	0.6 (0.2 to 1.5)

Population analysed: Safety population was analyzed. 'Overall Number of Participants (Par) Analyzed' (N)= par with at least 1 e-diary (within 7 days through Vaccination \[vax\]) transmitted. 1 par randomized in Sequential-Administration Group (SAG) incorrectly received RSVpreF + SIIV at Vax 1; hence, par was included in (RSVpreF + SIIV)/Placebo. 1 par randomized in SAG incorrectly received placebo at Vax 2; hence, par was included in vaccine group administered at Vax 1 and excluded from safety analysis at Vax 2.

Primary outcome: Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo

Time frame: Within 7 days after Vaccination 1 or Vaccination 2. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	RSVpreF + SIIV: Coadministration Group n = 701	Placebo: Coadministration Group n = 681	Placebo + SIIV: Sequential-Administration Group n = 693	RSVpreF: Sequential-Administration Group n = 686
Fever: Mild	1.1 (0.5 to 2.2)	0.7 (0.2 to 1.7)	0.9 (0.3 to 1.9)	1.0 (0.4 to 2.1)
Fever: Moderate	0.3 (0.0 to 1.0)	0.1 (0.0 to 0.8)	0.3 (0.0 to 1.0)	0.1 (0.0 to 0.8)
Fever: Severe	0.4 (0.1 to 1.2)	0 (0.0 to 0.5)	0.3 (0.0 to 1.0)	0 (0.0 to 0.5)
Fever: Grade 4 (>40.0 deg C)	0 (0.0 to 0.5)	0 (0.0 to 0.5)	0 (0.0 to 0.5)	0 (0.0 to 0.5)
Fatigue: Mild	15.4 (12.8 to 18.3)	10.1 (8.0 to 12.6)	15.6 (13.0 to 18.5)	11.5 (9.2 to 14.1)
Fatigue: Moderate	13.7 (11.2 to 16.5)	7.5 (5.6 to 9.7)	11.3 (9.0 to 13.8)	7.0 (5.2 to 9.2)
Fatigue: Severe	0.9 (0.3 to 1.9)	0 (0.0 to 0.5)	0.3 (0.0 to 1.0)	0.6 (0.2 to 1.5)
Headache: Mild	13.7 (11.2 to 16.5)	10.4 (8.2 to 13.0)	14.3 (11.8 to 17.1)	10.6 (8.4 to 13.2)

Population analysed: Safety population= all enrolled participants who received study intervention (RSVpreF, placebo). N= participant with at least 1 e-diary (within 7 days through vax) transmitted. 1 participant randomized in SAG incorrectly received RSVpreF + SIIV at Vax 1; hence, participant was included in (RSVpreF + SIIV)/Placebo. 1 participant randomized in SAG incorrectly received placebo at Vax 2; hence,participant was included in vaccine group administered at Vax 1 and excluded from safety analysis at Vax 2.

Primary outcome: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1

Time frame: Within 1 month after Vaccination 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	(RSVpreF + SIIV)/Placebo: Coadministration Group n = 703	(Placebo + SIIV)/RSVpreF: Sequential-Administration Group n = 695
Value	21.9 (18.9 to 25.1)	19.3 (16.4 to 22.4)

Population analysed: Safety population = all enrolled participants who received study intervention (RSVpreF, placebo). N = participants evaluable for this outcome measure. 1 participant randomized in SAG incorrectly received RSVpreF + SIIV at Vax 1; hence, participant was included in (RSVpreF + SIIV)/Placebo. 1 participant randomized in SAG incorrectly received placebo at Vax 2; hence, participant was included in vaccine group administered at Vax 1 and excluded from safety analysis at Vax 2.

Primary outcome: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 2

Time frame: Within 1 month after Vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	(RSVpreF + SIIV)/Placebo: Coadministration Group n = 689	(Placebo + SIIV)/RSVpreF: Sequential-Administration Group n = 691
Value	17.0 (14.3 to 20.0)	16.6 (13.9 to 19.6)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Local reactions (at the RSVpreF or placebo injection site) and systemic events (systematic assessment): Within 7 days after each vaccination. SAEs and other AEs: up to 1 month after Vaccination 1 and 2. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RSVpreF + SIIV: Coadministration Group	8 of 703 (1.1%)	418 of 703 (59.5%)	0 of 703
Placebo: Coadministration Group	2 of 689 (0.3%)	300 of 689 (43.5%)	0 of 689
Placebo + SIIV: Sequential-Administration Group	6 of 695 (0.9%)	370 of 695 (53.2%)	1 of 695
RSVpreF: Sequential-Administration Group	5 of 691 (0.7%)	330 of 691 (47.8%)	0 of 691

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37992000Athan 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

Related trials for Respiratory Syncytial Virus

RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

33 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVpreF Vaccine and Seasonal Inactivated Influenza Vaccine in people with Respiratory Syncytial Virus, run by Pfizer at 33 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo (time frame: Within 7 days after Vaccination 1 or Vaccination 2). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05301322, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.