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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06251024




Registration number
NCT06251024
Ethics application status
Date submitted
1/02/2024
Date registered
9/02/2024
Date last updated
5/06/2024

Titles & IDs
Public title
Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older
Scientific title
A Phase IIb, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an RSV Vaccine Candidate in Adult Participants 60 Years and Older
Secondary ID [1] 0 0
U1111-1271-1514
Secondary ID [2] 0 0
VAE00017
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - RSV vaccine candidate
Other interventions - Placebo

Experimental: Group 1: RSV vaccine candidate - Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the RSV vaccine candidate.

Placebo Comparator: Group 2: placebo - Participants will be enrolled in a 1:1 ratio to receive a single IM administration of the placebo.


Other interventions: RSV vaccine candidate
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection

Other interventions: Placebo
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B) = 14 days after vaccination
Timepoint [1] 0 0
= 14 days after vaccination
Secondary outcome [1] 0 0
Presence of the first episode of RSV-ARD (RSV A and/or RSV B) = 14 days after vaccination
Timepoint [1] 0 0
= 14 days after vaccination
Secondary outcome [2] 0 0
Presence of the first episode of RSV MAARD (RSV A and/or RSV B) = 14 days after vaccination
Timepoint [2] 0 0
= 14 days after vaccination
Secondary outcome [3] 0 0
Presence of the first episode of RSV LRTD (RSV A) occurring = 14 days after vaccination)
Timepoint [3] 0 0
= 14 days after vaccination
Secondary outcome [4] 0 0
Presence of the first episode of RSV LRTD (RSV B) occurring = 14 days after vaccination
Timepoint [4] 0 0
= 14 days after vaccination
Secondary outcome [5] 0 0
Presence of the first episode of RSV-LRTD (RSV A and/or RSV B and by each one) by age group
Timepoint [5] 0 0
= 14 days after vaccination
Secondary outcome [6] 0 0
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline comorbidities
Timepoint [6] 0 0
= 14 days after vaccination
Secondary outcome [7] 0 0
Presence of the first episode of RSV LRTD (RSV A and/or RSV B and by each one) by baseline frailty status
Timepoint [7] 0 0
= 14 days after vaccination
Secondary outcome [8] 0 0
Presence of hospitalization due to RSV-ARD and/or RSV-LRTD
Timepoint [8] 0 0
= 14 days after vaccination
Secondary outcome [9] 0 0
Duration (number of days) of RSV LRTD episodes (RSV A and/or RSV B)
Timepoint [9] 0 0
= 14 days after vaccination
Secondary outcome [10] 0 0
Duration (number of days) of RSV ARD episodes (RSV A and/or RSV B)
Timepoint [10] 0 0
= 14 days after vaccination
Secondary outcome [11] 0 0
Presence of the first episode of severe RSV LRTD (RSV A and/or RSV B and by each one) occurring = 14 days after vaccination
Timepoint [11] 0 0
= 14 days after vaccination
Secondary outcome [12] 0 0
RSV A serum neutralizing antibodies (nAb) titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Timepoint [12] 0 0
Day 1 and Day 29
Secondary outcome [13] 0 0
RSV B serum nAb titers at pre vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Timepoint [13] 0 0
Day 1 and Day 29
Secondary outcome [14] 0 0
Serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01) and 28 days (D29) post vaccination in the Immunogenicity Subset
Timepoint [14] 0 0
Day 1 and Day 29
Secondary outcome [15] 0 0
RSV A serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
Timepoint [15] 0 0
Month 6
Secondary outcome [16] 0 0
RSV B serum nAb titers at 6 months post-vaccination in the Immunogenicity Subset
Timepoint [16] 0 0
Month 6
Secondary outcome [17] 0 0
Serum anti-F IgG Ab titers at 6 months post-vaccination in the Immunogenicity Subset
Timepoint [17] 0 0
Month 6
Secondary outcome [18] 0 0
Presence of solicited injection site or systemic reactions
Timepoint [18] 0 0
Within 7 days after primary vaccination
Secondary outcome [19] 0 0
Presence of unsolicited immediate systemic adverse events (AEs)
Timepoint [19] 0 0
Within 30 minutes after primary vaccination
Secondary outcome [20] 0 0
Presence of unsolicited AEs
Timepoint [20] 0 0
Within 28 days after primary vaccination
Secondary outcome [21] 0 0
Presence of serious adverse events (SAEs)
Timepoint [21] 0 0
Throughout study (approximately 6 months)
Secondary outcome [22] 0 0
Presence of medically attended adverse events (MAAEs)
Timepoint [22] 0 0
Throughout study (approximately 6 months)
Secondary outcome [23] 0 0
Presence of adverse events of special interest (AESIs)
Timepoint [23] 0 0
Throughout study (approximately 6 months)

Eligibility
Key inclusion criteria
- Aged 60 years or older on the day of inclusion

- A female participant is eligible to participate if she is not pregnant or
breastfeeding and:

• 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.

- Participants with high-risk medical conditions who are determined by medical history,
physical examination (if required), and clinical judgment of the investigator to be
eligible for inclusion.
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:

- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
within the preceding 6 months; or long-term systemic corticosteroid therapy
(prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

- Known systemic hypersensitivity to any of the study intervention components (eg,
polyethylene glycol, polysorbate); history of a life-threatening reaction to the study
interventions used in the study or to a product containing any of the same substances
;any allergic reaction (eg, anaphylaxis) after administration of an mRNA vaccine

- History of RSV-associated illness, diagnosed clinically, serologically, or
microbiologically in the last 12 months

- Previous history of myocarditis, pericarditis, and/or myopericarditis

- Thrombocytopenia, contraindicating IM injection based on investigator's judgment

- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating IM injection

- Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with study conduct or completion

- Alcohol, prescription drug, or substance abuse that, in the opinion of the
investigator, might interfere with the study conduct or completion

- Receipt of any vaccine in the 4 weeks preceding any study intervention administration
or planned receipt of any vaccine in the 4 weeks following any study intervention
administration

- Receipt of any mRNA vaccine in the 60 days preceding any study intervention
administration or planned receipt of any mRNA vaccine in the 60 days following any
study intervention administration

- Previous vaccination against RSV with a licensed or investigational vaccine or planned
receipt during study participation, of vaccination against RSV with a licensed or
investigational vaccine other than the study vaccine

- Receipt of immune globulins, blood, or blood-derived products in the past 3 months

- Participation at the time of study enrollment (or in the 4 weeks preceding the first
study intervention administration) or planned participation during the present study
period in another clinical study investigating a vaccine, drug, medical device, or
medical procedure 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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
2/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/02/2025
Actual
Sample size
Target
4500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360003 - Botany
Recruitment hospital [2] 0 0
Investigational Site Number : 0360004 - Sippy Downs
Recruitment hospital [3] 0 0
Investigational Site Number : 0360001 - Southport
Recruitment hospital [4] 0 0
Investigational Site Number : 0360002 - Camberwell
Recruitment hospital [5] 0 0
Investigational Site Number : 0360005 - Norwood
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
4556 - Sippy Downs
Recruitment postcode(s) [3] 0 0
4222 - Southport
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
5067 - Norwood
Recruitment outside Australia
Country [1] 0 0
Dominican Republic
State/province [1] 0 0
Santo Domingo
Country [2] 0 0
Honduras
State/province [2] 0 0
San Pedro Sula
Country [3] 0 0
Honduras
State/province [3] 0 0
Tegucugalpa

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate
for the prevention of lower respiratory tract disease (LRTD) due to RSV.

The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to
receive a single intra-muscular (IM) administration of either a pre-determined dose of the
RSV vaccine candidate or placebo.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06251024
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06251024