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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

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
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
Secondary ID [1] 0 0
U1111-1304-9362
Secondary ID [2] 0 0
VBD00006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infection 0 0
Metapneumovirus Infection 0 0
Parainfluenzae Virus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination
Timepoint [1] 0 0
Within 30 minutes after each vaccination
Primary outcome [2] 0 0
Presence of solicited administration site reactions within 7 days after vaccination
Timepoint [2] 0 0
Within 7 days after vaccination
Primary outcome [3] 0 0
Presence of solicited systemic reactions within 7 days after vaccination
Timepoint [3] 0 0
Within 7 days after vaccination
Primary outcome [4] 0 0
Presence of unsolicited AEs within 28 days after vaccination
Timepoint [4] 0 0
Within 28 days after vaccination
Primary outcome [5] 0 0
Presence of serious adverse events (SAEs)
Timepoint [5] 0 0
Within 6 months after vaccination
Primary outcome [6] 0 0
Presence of adverse events of special interest (AESIs)
Timepoint [6] 0 0
Within 6 months after vaccination
Primary outcome [7] 0 0
Presence of related SAEs throughout the study
Timepoint [7] 0 0
Throughout the study, approximately 12 months
Primary outcome [8] 0 0
Presence of related AESIs throughout the study
Timepoint [8] 0 0
Throughout the study, approximately 12 months
Primary outcome [9] 0 0
Presence of related fatal SAEs throughout the study
Timepoint [9] 0 0
Throughout the study, approximately 12 months
Primary outcome [10] 0 0
Presence of out-of-range biological test results (including shift from baseline values)
Timepoint [10] 0 0
Within 7 days after vaccination
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
At Day 01 and Day 29
Secondary outcome [2] 0 0
RSV B serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 and RSV vaccines
Timepoint [2] 0 0
At Day 01 and Day 29
Secondary outcome [3] 0 0
hMPV A serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV +/- PIV3 vaccines
Timepoint [3] 0 0
At Day 01 and Day 29
Secondary outcome [4] 0 0
PIV3 serum nAb titers at pre-vaccination (Day 01) and post-vaccination (Day 29) in the RSV/hMPV/PIV3 and PIV3 vaccines
Timepoint [4] 0 0
At Day 01 and Day 29

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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/01/2026
Actual
Sample size
Target
390
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - Botany
Recruitment hospital [2] 0 0
Investigational Site Number : 0360009 - Brookvale
Recruitment hospital [3] 0 0
Investigational Site Number : 0360004 - Miranda
Recruitment hospital [4] 0 0
Investigational Site Number : 0360008 - Herston
Recruitment hospital [5] 0 0
Investigational Site Number : 0360003 - Bayswater
Recruitment hospital [6] 0 0
Investigational Site Number : 0360002 - Camberwell
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2100 - Brookvale
Recruitment postcode(s) [3] 0 0
2228 - Miranda
Recruitment postcode(s) [4] 0 0
4006 - Herston
Recruitment postcode(s) [5] 0 0
3153 - Bayswater
Recruitment postcode(s) [6] 0 0
3124 - Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
Contact-US@sanofi.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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