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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06583031




Registration number
NCT06583031
Ethics application status
Date submitted
30/08/2024
Date registered
3/09/2024

Titles & IDs
Public title
Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years
Scientific title
A Phase 1, Randomized, Modified Double-blind, Multi-center, Parallel Group, Multi-arm Study to Investigate the Safety and Immunogenicity of an RSV/hMPV Vaccine Candidate in Adult Participants Aged 60 to 75 Years
Secondary ID [1] 0 0
U1111-1308-3615
Secondary ID [2] 0 0
VAV00039
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
RSV Infection 0 0
hMPV 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 - RSV/hMPV vaccine dose A1
Treatment: Other - RSV/hMPV vaccine dose A2
Treatment: Other - RSV/hMPV vaccine dose A3
Treatment: Other - RSV/hMPV vaccine dose B1
Treatment: Other - RSV/hMPV vaccine dose B2
Treatment: Other - RSV/hMPV vaccine dose B3
Treatment: Other - RSV/hMPV vaccine dose C1
Treatment: Other - RSV/hMPV vaccine dose C2
Treatment: Other - RSV/hMPV vaccine dose C3
Treatment: Other - RSV/hMPV vaccine dose 1
Treatment: Other - RSV/hMPV vaccine dose 2
Treatment: Other - RSV/hMPV vaccine dose 3
Treatment: Other - Monovalent RSV Vaccine

Experimental: Group 1 RSV/hMPV dose A1 - Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 2 RSV/hMPV dose A2 - Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 3 RSV/hMPV dose A3 - Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 4 RSV/hMPV dose B1 - Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 5 RSV/hMPV dose B2 - Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 6 RSV/hMPV dose B3 - Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 7 RSV/hMPV dose C1 - Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 8 RSV/hMPV dose C2 - Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 9 RSV/hMPV dose C3 - Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 10 RSV/hMPV dose 1 - Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 11 RSV/hMPV dose 2 - Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 12 RSV/hMPV dose 3 - Participants will receive a single IM injection on day 1 of the RSV/hMPV vaccines according to their randomization schedule.

Experimental: Group 13 Monovalent RSV Vaccine - Participants will receive a single IM injection on day 1 of a Monovalent (MV) RSV vaccine according to their randomization schedule.


Treatment: Other: RSV/hMPV vaccine dose A1
Suspension for injection. Route of administration: IM injection

Treatment: Other: RSV/hMPV vaccine dose A2
Suspension for injection. Route of administration: IM injection

Treatment: Other: RSV/hMPV vaccine dose A3
Suspension for injection. Route of administration: IM injection

Treatment: Other: RSV/hMPV vaccine dose B1
Suspension for injection. Route of administration: IM injection

Treatment: Other: RSV/hMPV vaccine dose B2
Suspension for injection. Route of administration: IM injection

Treatment: Other: RSV/hMPV vaccine dose B3
Suspension for injection. Route of administration: IM injection

Treatment: Other: RSV/hMPV vaccine dose C1
Suspension for injection. Route of administration: IM injection

Treatment: Other: RSV/hMPV vaccine dose C2
Suspension for injection. Route of administration: IM injection

Treatment: Other: RSV/hMPV vaccine dose C3
Suspension for injection. Route of administration: IM injection

Treatment: Other: RSV/hMPV vaccine dose 1
Suspension for injection. Route of administration: IM injection

Treatment: Other: RSV/hMPV vaccine dose 2
Suspension for injection. Route of administration: IM injection

Treatment: Other: RSV/hMPV vaccine dose 3
Suspension for injection. Route of administration: IM injection

Treatment: Other: Monovalent RSV Vaccine
Suspension for injection. Route of administration: IM injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination
Timepoint [1] 0 0
On Day 1
Primary outcome [2] 0 0
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination
Timepoint [2] 0 0
Day 1 through day 8
Primary outcome [3] 0 0
Presence of unsolicited AEs reported through 28 days after vaccination
Timepoint [3] 0 0
Day 1 through day 29
Primary outcome [4] 0 0
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination
Timepoint [4] 0 0
SAE: Screening through day 181; AESI: Day 1 through day 181
Primary outcome [5] 0 0
Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination
Timepoint [5] 0 0
Screening through day 8
Secondary outcome [1] 0 0
RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants
Timepoint [1] 0 0
At day 1 and day 29
Secondary outcome [2] 0 0
hMPV A serum nAb titers at pre-vaccination and 28 days post-vaccination in all participants, except in those receiving the MV RSV vaccine
Timepoint [2] 0 0
At day 1 and day 28
Secondary outcome [3] 0 0
RSV A and RSV B nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants
Timepoint [3] 0 0
At day 1, day 29, day 91, and day 181
Secondary outcome [4] 0 0
RSV A serum anti-F IgG (immunoglobulin type G) Ab (Antibody) titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants
Timepoint [4] 0 0
At day 1, day 29, day 91, and day 181
Secondary outcome [5] 0 0
hMPV A nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine
Timepoint [5] 0 0
At day 1, day 29, day 91, and day 181
Secondary outcome [6] 0 0
hMPV serum anti-F IgG Ab titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine
Timepoint [6] 0 0
At day 1, day 29, day 91, and day 181

Eligibility
Key inclusion criteria
* Aged 60 to 75 years on the day of inclusion
* A female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile
Minimum age
60 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
* 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 administering the treatment/s

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
9/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/08/2025
Actual
Sample size
Target
390
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Site # 0361004 - Botany
Recruitment hospital [2] 0 0
Site # 031001 - Brookvale
Recruitment hospital [3] 0 0
Site # 0361006 - Miranda
Recruitment hospital [4] 0 0
Site # 0361002 - Wollongong
Recruitment hospital [5] 0 0
Site # 0361003 - Herston
Recruitment hospital [6] 0 0
Site # 0361005 - South Brisbane
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
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4006 - Herston
Recruitment postcode(s) [6] 0 0
4101 - South Brisbane

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
Sanofi Trial Transparency Email Recommended (Toll free for US and Canada
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
contact-us@saonofi.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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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/NCT06583031