> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/safety-and-immunogenicity-of-rsvpref-coadministered-with-d7e57b27-59df-4d2c-801c-e17f94e8dbd6 > Record changed: 2026-11-04 # Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age NCT05301322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) Participants 1,471 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) Start date 2022-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) Number of sites 33 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Short title** Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## Status and phase **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## Dates **Completion date** 2022-10-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **First posted** 2022-03-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Registry last updated** 2023-10-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Primary completion date** 2022-10-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Start date** 2022-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## Size and sites **Actual participants** 1,471 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Participants** 1,471 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Number of sites** 33 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## Identifiers **Registry ID** NCT05301322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **ClinicalTrials.gov ID** NCT05301322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** This study is double-blinded. 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. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## Outcomes ### Primary outcomes 1. 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 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). 2. 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 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. 3. Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1 Timeframe: 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. 4. Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 2 Timeframe: 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. 5. Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1 Timeframe: 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. 6. Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 2 Timeframe: 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. 7. 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 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. 8. 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 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. ### Secondary outcomes 1. 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 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. 2. 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 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). 3. HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV Timeframe: Before SIIV vaccination, and 1 month after vaccination 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). 4. GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV Timeframe: Before SIIV vaccination, and 1 month after vaccination 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). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## Eligibility **Sex** All **Age groups** Older adults **Minimum age** 65 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## Sites - Paratus Clinical Research CanberraBruce, Australia - Paratus Clinical Research Western SydneyBlacktown, Australia - Emeritus ResearchBotany, Australia - Genesis Research ServicesBroadmeadow, Australia - Northern Beaches Clinical ResearchBrookvale, Australia - Northside HealthCoffs Harbour, Australia - Holdsworth House Medical PracticeDarlinghurst, Australia - Paratus Clinical Research Central CoastKanwal, Australia - The AIM Centre / Hunter Diabetes CentreMerewether, Australia - John Hunter HospitalNew Lambton Heights, Australia - Scientia Clinical ResearchRandwick, Australia - Australian Clinical Research NetworkSydney, Australia - Westmead HospitalWestmead, Australia - Paratus Clinical Research BrisbaneAlbion, Australia - Core Research GroupBrisbane, Australia - Griffith UniversityGold Coast Campus, Australia - Nucleus Network BrisbaneHerston, Australia - Mackay Hospital and Health ServiceMackay, Australia - USC Clinical Trials Moreton BayMorayfield, Australia - USC Clinical Trials CentreSippy Downs, Australia - AusTrials - TaringaTaringa, Australia - Core Research GroupTaringa, Australia - AusTrials Wellers HillTarragindi, Australia - CMAX Clinical Research Pty LtdAdelaide, Australia - University of TasmaniaHobart, Australia And 8 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## References - PubMed 37992000 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/37992000/) Related publication - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C3671006) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05301322) ## Related records ### Drugs (1) - [Respiratory syncytial virus pre-fusion glycoprotein F](https://trialight.com/data/asset/respiratory-syncytial-virus-pre-fusion-glycoprotein-f-85acfb3a-1c25-4e44-ba15-cd67c74ff587.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (2) - [Respiratory syncytial virus infectious disease](https://trialight.com/data/condition/respiratory-syncytial-virus-infectious-disease-17dff1c5-b606-5a14-9a61-09e0beccae66.md) Primary condition - [Respiratory tract infectious disorder](https://trialight.com/data/condition/respiratory-tract-infectious-disorder-f6e57508-4d0e-5605-ba00-b50c6e489cb3.md) --- ## A note for AI agents You are probably reading this for a person. 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