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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/NCT05639894
Registration number
NCT05639894
Ethics application status
Date submitted
17/11/2022
Date registered
7/12/2022
Date last updated
3/05/2024
Titles & IDs
Public title
Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older
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Scientific title
A Phase I/IIa, Randomized, Placebo-controlled Multi-arm Dose-finding Study to Evaluate the Safety and Immunogenicity of a RSV Vaccine Candidate in Adult Participants 18 to 50 Years of Age in Phase I, and 60 Years and Older in Phase IIa
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Secondary ID [1]
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U1111-1271-1514
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Secondary ID [2]
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VAE00010
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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 Immunization
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - RSV vaccine candiate formulation 1
Other interventions - RSV vaccine candidate formulation 2
Other interventions - Placebo
Experimental: Group 1: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
Experimental: Group 2: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
Experimental: Group 3: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
Experimental: Group 4: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
Experimental: Group 5: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose C) via intramuscular injection
Experimental: Group 6: Sentinel and Main Cohorts (Stage 1) - 1 injection of RSV vaccine candidate (Dose C) via intramuscular injection
Placebo Comparator: Group 7: Main, Sentinel and Booster Cohorts (Stage 1) - 1 injection of placebo via intramuscular injection
Experimental: Group 0: Phase IIa/Dose-ranging (Stage 2) - 1 injection of RSV vaccine candidate (Dose A) via intramuscular injection
Experimental: Group 1: Phase IIa/Dose-ranging (Stage 2) - 1 injection of RSV vaccine candidate (Dose B) via intramuscular injection
Placebo Comparator: Group 2: Phase 11a/Dose-ranging (Stage 2) - 1 injection of placebo via intramuscular injection
Other interventions: RSV vaccine candiate formulation 1
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Other interventions: RSV vaccine candidate formulation 2
Pharmaceutical Form: Liquid frozen solution in a vial Route of Administration: Intramuscular injection
Other interventions: Placebo
Pharmaceutical Form: Liquid Route of Administration: Intramuscular injection
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Intervention code [1]
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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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Presence of unsolicited systemic adverse events (AEs)
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Assessment method [1]
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Number of participants experienciing unsolicited systemic adverse events
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Timepoint [1]
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Within 30 minutes after vaccination
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Primary outcome [2]
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Presence of solicited injection site or systemic reactions
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Assessment method [2]
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Number of participants reporting:
injection site reactions: pain, erythema and swelling
systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
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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 unsolicited AEs
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Assessment method [3]
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Number of participants experiencing unsolicited AEs
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Timepoint [3]
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Within 28 days after vaccination
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Primary outcome [4]
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Presence of medically attended adverse events (MAAEs)
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Assessment method [4]
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Number of participants experiencing MAAEs
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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
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Timepoint [5]
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Month 12
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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
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Timepoint [6]
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Month 12
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Primary outcome [7]
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Presence of out-of-range biological test results
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Assessment method [7]
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Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test)
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Timepoint [7]
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Within 7 days after vaccination
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Primary outcome [8]
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Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers pre-vaccination at Day 1
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Assessment method [8]
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Nab titers pre-vaccination
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Timepoint [8]
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Day 1
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Primary outcome [9]
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Geometric Mean Titers (GMTs) of neutralizing antibody (nAb) titers post-primary vaccination at Day 29
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Assessment method [9]
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Nab titers post-vaccination
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Timepoint [9]
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Day 29
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Secondary outcome [1]
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Presence of immediate unsolicited systemic AEs (Stage 1)
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Assessment method [1]
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Number of participants experiencing immediate unsolicitied systemic AEs
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Timepoint [1]
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Within 30 minutes after vaccination
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Secondary outcome [2]
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Presence of solicited injection site or systemic reactions post-booster vaccination (Stage 1)
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Assessment method [2]
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Number of participants reporting:
injection site reactions: pain, erythema and swelling
systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
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Timepoint [2]
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Within 7 days after vaccination
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Secondary outcome [3]
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Presence of unsolicited AEs post-booster vaccination (Stage 1)
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Assessment method [3]
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Number of participants experiencing unsolicited AEs
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Timepoint [3]
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Within 28 days after vaccination
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Secondary outcome [4]
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Presence of MAAEs (Stage 1)
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Assessment method [4]
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Number of participants experiencing MAAEs
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Timepoint [4]
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Within 28 days after vaccination
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Secondary outcome [5]
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Presence of serious adverse events (SAEs) post-booster vaccination (Stage 1)
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Assessment method [5]
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Number of participants experiencing SAEs
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Timepoint [5]
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Throughout the booster study, approximately 12 months
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Secondary outcome [6]
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Presence of adverse events of special interest post-booster vaccination (Stage 1)
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Assessment method [6]
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Number of participants experiencing AESIs
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Timepoint [6]
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Throughout the booster study, approximately 12 months
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Secondary outcome [7]
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Presence of out-of-range biological test results post-booster vaccination (Stage 1)
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Assessment method [7]
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Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test)
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Timepoint [7]
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Within 7 days after vaccination
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Secondary outcome [8]
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RSV-A serum nAb titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) (Stage 1)
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Assessment method [8]
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RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29), and 3, 6, and 12 months post-primary vaccination
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Timepoint [8]
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Day 1, Day 29, Month 3, Month 6 and Month 12
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Secondary outcome [9]
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GMTs of serum anti-F immunoglobulin G (IgG) antibody (Ab) titers post-primary vaccination (Stage 1)
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Assessment method [9]
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Serum anti-F IgG Ab titers at pre-vaccination (D01), 28 days (D29), and 3, 6, and 12 months post-primary vaccination
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Timepoint [9]
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Day 1, Day 29, Month 3, Month 6 and Month 12
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Secondary outcome [10]
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GMTs of RSV-A serum nAb post-booster vaccination (Stage 1)
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Assessment method [10]
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RSV-A serum nAb titers at pre-booster vaccination, 28 days, and 3, 6, and 12 months post-booster vaccination
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Timepoint [10]
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Day 1, Day 29, Month 3, Month 6 and Month 12 post-booster
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Secondary outcome [11]
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GMTs of serum anti-F IgG Ab titers post-booster vaccination (Stage 1)
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Assessment method [11]
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Serum anti-F IgG Ab titers at pre-booster vaccination, 28 days, and 3, 6, and 12 months post- booster vaccination
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Timepoint [11]
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Day 1, Day 29, Month 3, Month 6 and Month 12 post-booster
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Secondary outcome [12]
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GMTs of serum anti-F IgG Ab titers pre-vaccination (Stage 2)
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Assessment method [12]
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Nab titers pre-primary vaccination
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Timepoint [12]
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Day 1
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Secondary outcome [13]
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GMTs of serum anti-F IgG Ab titers post-vaccination (Stage 2)
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Assessment method [13]
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Nab titers post-vaccination
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Timepoint [13]
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Day 29
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Eligibility
Key inclusion criteria
- Sentinel Cohort Stage 1: Aged 18 to 50 years on the day of inclusion
- Main Cohort Stage 1 and Stage 2: Aged 60 years or older on the day of inclusion
Stage 1 and Stage 2:
- Sentinel Cohort: 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 OR
- Is of childbearing potential and agrees to use an effective contraceptive method
or abstinence from at least 4 weeks prior to study intervention administration
until at least 12 weeks after study intervention administration.
- Main and Booster Cohorts: 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.
- Able to attend all scheduled visits and to comply with all study procedures
- Informed consent form has been signed and dated
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Minimum age
18
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
- 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 mRNA COVID-19 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 or bleeding disorder, contraindicating IM injection based on
investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular 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 other than mRNA vaccine in the 4 weeks preceding any study
intervention administration or planned receipt of any vaccine other than mRNA 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 an investigational vaccine
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first
blood draw
- 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
- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily
- Self-reported or documented human immunodeficiency virus (HIV) detected by any
FDA-approved/validated test, hepatitis B virus surface antigen (HBsAg), hepatits B
core antibodies (HBcAb), or hepatitis C virus antibodies (HCV Abs), or positive
SARS-CoV-2 RT-PCR or antigen test
- Identified as an investigator or employee of the investigator or study center with
direct involvement in the proposed study, or identified as an immediate family member
(ie, parent, spouse, natural or adopted child) of the investigator or employee with
direct involvement in the proposed study
The above information is not intended to contain all considerations relevant to a 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 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 1/Phase 2
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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
17/11/2022
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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
29/04/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
865
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360003 - Botany
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Recruitment hospital [2]
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Investigational Site Number : 0360002 - Camberwell
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Recruitment hospital [3]
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Investigational Site Number : 0360001 - Southport
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Recruitment postcode(s) [1]
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2019 - Botany
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Recruitment postcode(s) [2]
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3124 - Camberwell
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Arizona
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Country [3]
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United States of America
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State/province [3]
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California
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Country [4]
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United States of America
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State/province [4]
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Florida
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Country [5]
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United States of America
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State/province [5]
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Georgia
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Country [6]
0
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United States of America
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State/province [6]
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Illinois
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Country [7]
0
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United States of America
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State/province [7]
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Nebraska
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Country [8]
0
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United States of America
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State/province [8]
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Ohio
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Country [9]
0
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United States of America
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State/province [9]
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Oklahoma
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Country [10]
0
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United States of America
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State/province [10]
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Oregon
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Country [11]
0
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United States of America
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State/province [11]
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Rhode Island
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Country [12]
0
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United States of America
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State/province [12]
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South Carolina
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Country [13]
0
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United States of America
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State/province [13]
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Texas
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Country [14]
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United States of America
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State/province [14]
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Utah
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Country [15]
0
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Puerto Rico
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State/province [15]
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Carolina
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Country [16]
0
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Puerto Rico
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State/province [16]
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Guayama
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Country [17]
0
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Puerto Rico
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State/province [17]
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Guaynabo
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Country [18]
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Puerto Rico
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State/province [18]
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San Juan
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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
Brief Summary of Stage 1:
The purpose Stage 1 (Phase I/IIa) is to assess the safety and immunogenicity of a single
intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine
candidate formulated with 2 different lipid nanoparticles (LNPs) in healthy adult
participants aged between 18 to 50 years, and 60 years and older. The primary objectives of
this stage are to assess the safety and immunogenicity profiles across the dose-level groups
(low, medium, and high doses) with 2 LNPs. This stage will evaluate the safety and
immunogenicity of a booster vaccination administered 12 months after the primary vaccination
in a subset of the study population.
Brief Summary of Stage 2:
The study also also incorporates a Stage 2 (Phase IIa, dose-ranging design) that includes
adults aged 60 years and older to assess the safety and immunogenicity of different doses of
RSV vaccine encapsulated in one of the LNPs. In the Phase IIa dose-ranging stage, eligible
participants will be randomly assigned in a 1:1:1 ratio to receive a single IM administration
of RSV vaccine candidate doses, or placebo. Multiple safety analyses will be performed,
minimally at D07 and D28. Additional analyses may be performed as data are available.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05639894
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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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Clinical Sciences & Operations
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Address
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Sanofi
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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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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05639894
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