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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
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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
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Secondary ID [1]
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C3671006
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo
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Assessment method [1]
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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).
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Timepoint [1]
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Within 7 days after Vaccination 1 or Vaccination 2
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Primary outcome [2]
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Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo
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Assessment method [2]
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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.
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Timepoint [2]
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Within 7 days after Vaccination 1 or Vaccination 2
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Primary outcome [3]
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Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1
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Assessment method [3]
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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.
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Timepoint [3]
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Within 1 month after Vaccination 1
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Primary outcome [4]
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Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 2
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Assessment method [4]
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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.
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Timepoint [4]
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Within 1 month after Vaccination 2
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Primary outcome [5]
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Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1
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Assessment method [5]
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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.
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Timepoint [5]
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Within 1 month after Vaccination 1
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Primary outcome [6]
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Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 2
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Assessment method [6]
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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.
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Timepoint [6]
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Within 1 month after Vaccination 2
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Primary outcome [7]
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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
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Assessment method [7]
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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.
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Timepoint [7]
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1 month after Vaccination 1 for Coadministration Group and 1 month after Vaccination 2 for Sequential-Administration Group
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Primary outcome [8]
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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
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Assessment method [8]
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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.
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Timepoint [8]
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1 month after Vaccination 1
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Secondary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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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
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Secondary outcome [2]
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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
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Assessment method [2]
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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).
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Timepoint [2]
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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
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Secondary outcome [3]
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HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV
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Assessment method [3]
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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).
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Timepoint [3]
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Before SIIV vaccination, and 1 month after vaccination
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Secondary outcome [4]
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GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV
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Assessment method [4]
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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).
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Timepoint [4]
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Before SIIV vaccination, and 1 month after vaccination
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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
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/10/2022
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Sample size
Target
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Accrual to date
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Final
1471
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Paratus Clinical Research Canberra - Bruce
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Recruitment hospital [2]
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Paratus Clinical Research Western Sydney - Blacktown
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Recruitment hospital [3]
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Emeritus Research - Botany
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Recruitment hospital [4]
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Genesis Research Services - Broadmeadow
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Recruitment hospital [5]
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Northern Beaches Clinical Research - Brookvale
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Recruitment hospital [6]
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Northside Health - Coffs Harbour
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Recruitment hospital [7]
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Holdsworth House Medical Practice - Darlinghurst
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Recruitment hospital [8]
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Paratus Clinical Research Central Coast - Kanwal
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Recruitment hospital [9]
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The AIM Centre / Hunter Diabetes Centre - Merewether
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Recruitment hospital [10]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [11]
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Scientia Clinical Research - Randwick
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Recruitment hospital [12]
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Australian Clinical Research Network - Sydney
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Recruitment hospital [13]
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Westmead Hospital - Westmead
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Recruitment hospital [14]
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Paratus Clinical Research Brisbane - Albion
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Recruitment hospital [15]
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Core Research Group - Brisbane
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Recruitment hospital [16]
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Griffith University - Gold Coast Campus
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Recruitment hospital [17]
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Nucleus Network Brisbane - Herston
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Recruitment hospital [18]
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Mackay Hospital and Health Service - Mackay
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Recruitment hospital [19]
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USC Clinical Trials Moreton Bay - Morayfield
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Recruitment hospital [20]
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USC Clinical Trials Centre - Sippy Downs
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Recruitment hospital [21]
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AusTrials - Taringa - Taringa
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Recruitment hospital [22]
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Core Research Group - Taringa
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Recruitment hospital [23]
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AusTrials Wellers Hill - Tarragindi
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Recruitment hospital [24]
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CMAX Clinical Research Pty Ltd - Adelaide
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Recruitment hospital [25]
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University of Tasmania - Hobart
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Recruitment hospital [26]
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Box Hill Hospital - Box Hill
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Recruitment hospital [27]
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Emeritus Research - Camberwell
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Recruitment hospital [28]
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Barwon Health - Geelong
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Recruitment hospital [29]
0
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Doctors of Ivanhoe - Ivanhoe
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Recruitment hospital [30]
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Nucleus Network Brisbane - Melbourne
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Recruitment hospital [31]
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Nucleus Network Melbourne - Melbourne
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Recruitment hospital [32]
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Institute for Respiratory Health - Nedlands
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Recruitment hospital [33]
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Latitude Clinical Research - Spearwood
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Recruitment postcode(s) [1]
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2617 - Bruce
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Recruitment postcode(s) [2]
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2148 - Blacktown
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Recruitment postcode(s) [3]
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2019 - Botany
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Recruitment postcode(s) [4]
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2292 - Broadmeadow
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Recruitment postcode(s) [5]
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2100 - Brookvale
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Recruitment postcode(s) [6]
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2450 - Coffs Harbour
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Recruitment postcode(s) [7]
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2010 - Darlinghurst
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Recruitment postcode(s) [8]
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2259 - Kanwal
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Recruitment postcode(s) [9]
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2291 - Merewether
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Recruitment postcode(s) [10]
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2305 - New Lambton Heights
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Recruitment postcode(s) [11]
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2031 - Randwick
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Recruitment postcode(s) [12]
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NSW 2035 - Sydney
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Recruitment postcode(s) [13]
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2145 - Westmead
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Recruitment postcode(s) [14]
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4010 - Albion
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Recruitment postcode(s) [15]
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4064 - Brisbane
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Recruitment postcode(s) [16]
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4222 - Gold Coast Campus
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Recruitment postcode(s) [17]
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4006 - Herston
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Recruitment postcode(s) [18]
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4740 - Mackay
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Recruitment postcode(s) [19]
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4506 - Morayfield
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Recruitment postcode(s) [20]
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4556 - Sippy Downs
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Recruitment postcode(s) [21]
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4068 - Taringa
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Recruitment postcode(s) [22]
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4121 - Tarragindi
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Recruitment postcode(s) [23]
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5000 - Adelaide
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Recruitment postcode(s) [24]
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7000 - Hobart
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Recruitment postcode(s) [25]
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3128 - Box Hill
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Recruitment postcode(s) [26]
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3124 - Camberwell
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Recruitment postcode(s) [27]
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3220 - Geelong
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Recruitment postcode(s) [28]
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3079 - Ivanhoe
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Recruitment postcode(s) [29]
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3004 - Melbourne
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Recruitment postcode(s) [30]
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6009 - Nedlands
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Recruitment postcode(s) [31]
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6163 - Spearwood
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05301322
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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0
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Fax
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Email
0
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/22/NCT05301322/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/22/NCT05301322/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05301322