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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06604767
Registration number
NCT06604767
Ethics application status
Date submitted
17/09/2024
Date registered
19/09/2024
Date last updated
4/04/2025
Titles & IDs
Public title
Study of a Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adults Aged 60 Years and Older
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Scientific title
A Phase 1, Dose-Escalation, Randomized, Active-Controlled, Modified Double-Blind, Parallel-Group, Multi-Arm Study to Investigate the Safety and Immunogenicity of a Combined Respiratory Syncytial Virus/Human Metapneumovirus/Parainfluenza Virus Type 3 Vaccine Candidate in Adult Participants Aged 60 Years and Older
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Secondary ID [1]
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U1111-1304-9362
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Secondary ID [2]
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VBD00006
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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 Infection
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Metapneumovirus Infection
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Parainfluenzae Virus Infection
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Condition category
Condition code
Infection
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0
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Studies of infection and infectious agents
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Infection
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0
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0
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - parainfluenza virus type 3 vaccine (PIV3)
Treatment: Other - RSV/hMPV/PIV3 vaccine
Treatment: Other - RSV/hMPV vaccine
Treatment: Other - RSV vaccine 1
Treatment: Other - RSV vaccine 2
Experimental: PIV3 Dose 1 - Participants will receive a single intramuscular (IM) injection at Day 1
Experimental: PIV3 Dose 2 - Participants will receive a single intramuscular (IM) injection at Day 1
Experimental: PIV3 Dose 3 - Participants will receive a single intramuscular (IM) injection at Day 1
Experimental: PIV3 Dose 4 - Participants will receive a single intramuscular (IM) injection at Day 1
Experimental: RSV/hMPV /PIV3 Formulation 1 - Participants will receive a single intramuscular (IM) injection at Day 1
Experimental: RSV/hMPV Formulation 1 - Participants will receive a single intramuscular (IM) injection at Day 1
Experimental: RSV/hMPV Formulation 2 - Participants will receive a single intramuscular (IM) injection at Day 1
Experimental: RSV vaccine 1 - Participants will receive a single intramuscular (IM) injection at Day 1
Experimental: RSV vaccine 2 - Participants will receive a single intramuscular (IM) injection at Day 1
Treatment: Other: parainfluenza virus type 3 vaccine (PIV3)
Pharmaceutical form:Frozen liquid solution -Route of administration:Intramuscular
Treatment: Other: RSV/hMPV/PIV3 vaccine
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
Treatment: Other: RSV/hMPV vaccine
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
Treatment: Other: RSV vaccine 1
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Treatment: Other: RSV vaccine 2
Pharmaceutical form:Frozen liquid solution-Route of administration:Intramuscular
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Intervention code [1]
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Treatment: Other
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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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Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
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Assessment method [1]
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Number of participants experiencing immediate unsolicited systemic AEs
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Timepoint [1]
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Within 30 minutes after each vaccination
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Primary outcome [2]
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Presence of solicited administration site reactions within 7 days after vaccination
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Assessment method [2]
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Number of participants reporting: - injection site reactions: pain, erythema and swelling
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Timepoint [2]
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Within 7 days after vaccination
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Primary outcome [3]
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Presence of solicited systemic reactions within 7 days after vaccination
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Assessment method [3]
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Number of participants reporting: * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
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Timepoint [3]
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Within 7 days after vaccination
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Primary outcome [4]
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Presence of unsolicited AEs within 28 days after vaccination
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Assessment method [4]
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Number of participants experiencing unsolicited AEs
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Timepoint [4]
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Within 28 days after vaccination
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Primary outcome [5]
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Presence of serious adverse events (SAEs)
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Assessment method [5]
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Number of participants experiencing SAEs regardless of causality
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Timepoint [5]
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Within 6 months after vaccination
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Primary outcome [6]
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Presence of adverse events of special interest (AESIs)
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Assessment method [6]
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Number of participants experiencing AESIs regardless of causality
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Timepoint [6]
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Within 6 months after vaccination
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Primary outcome [7]
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Presence of related SAEs throughout the study
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Assessment method [7]
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Number of participants experiencing related SAEs regardless of causality
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Timepoint [7]
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Throughout the study, approximately 12 months
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Primary outcome [8]
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Presence of related AESIs throughout the study
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Assessment method [8]
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Number of participants experiencing related AESIs regardless of causality
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Timepoint [8]
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Throughout the study, approximately 12 months
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Primary outcome [9]
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Presence of related fatal SAEs throughout the study
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Assessment method [9]
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Number of participants experiencing related fatal SAEs regardless of causality
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Timepoint [9]
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Throughout the study, approximately 12 months
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Primary outcome [10]
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Presence of out-of-range biological test results (including shift from baseline values)
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Assessment method [10]
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Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
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Timepoint [10]
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Within 7 days after vaccination
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Secondary outcome [1]
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RSV A serum neutralizing antibody (nAb) titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
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Assessment method [1]
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Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
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Timepoint [1]
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At Day 01 and Day 29
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Secondary outcome [2]
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RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
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Assessment method [2]
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Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
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Timepoint [2]
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At Day 01 and Day 29
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Secondary outcome [3]
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hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines
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Assessment method [3]
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Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
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Timepoint [3]
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At Day 01 and Day 29
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Secondary outcome [4]
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PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines
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Assessment method [4]
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Antibody titers are expressed as GMTs at pre-vaccination and post-vaccination
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Timepoint [4]
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At Day 01 and Day 29
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Eligibility
Key inclusion criteria
* Aged 60 years or older on the day of inclusion (means from the means from the day of the 60th birthday).
* Informed consent form (ICF) has been signed and dated
* A female participant is eligible to participate if she is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
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Minimum age
60
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
Participants are excluded from the study if any of the following criteria apply:
-Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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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 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 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
17/09/2024
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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
5/03/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
390
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360006 - Blacktown
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Recruitment hospital [2]
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Investigational Site Number : 0360001 - Botany
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Recruitment hospital [3]
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Investigational Site Number : 0360009 - Brookvale
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Recruitment hospital [4]
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Investigational Site Number : 0360005 - Kanwal
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Recruitment hospital [5]
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Investigational Site Number : 0360004 - Miranda
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Recruitment hospital [6]
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Investigational Site Number : 0360008 - Herston
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Recruitment hospital [7]
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Investigational Site Number : 0360003 - Bayswater
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Recruitment hospital [8]
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Investigational Site Number : 0360002 - Camberwell
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2019 - Botany
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Recruitment postcode(s) [3]
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2100 - Brookvale
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Recruitment postcode(s) [4]
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2259 - Kanwal
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Recruitment postcode(s) [5]
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2228 - Miranda
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Recruitment postcode(s) [6]
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4006 - Herston
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Recruitment postcode(s) [7]
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3153 - Bayswater
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Recruitment postcode(s) [8]
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3124 - Camberwell
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi Pasteur, a Sanofi Company
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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 phase 1 study is to evaluate whether the vaccine is safe and can help the body to develop germ fighting agents called "antibodies" (immunogenicity) against the respiratory syncytial virus (RSV), human metapneumovirus (hMPV), and parainfluenza virus type 3 (PIV3). The study will use different doses of PIV3 only and different combinations of RSV/hMPV/PIV3 or RSV/hMPV or only RSV vaccine in adults aged 60 years and older.
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Trial website
https://clinicaltrials.gov/study/NCT06604767
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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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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 public queries
Name
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Trial Transparency email recommended (Toll free for US & Canada)
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Address
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Country
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06604767
Download to PDF