Research Centers of America | Hollywood, FL
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full description
Stage 1:
The duration of each participant's participation is 12 months for the Sentinel and Main Cohorts, 24 months overall for the subset of participants enrolled in the Booster Cohort.
Treatment Duration:
Stage 2:
The duration of each participant's participation is approximately 6 months.
Treatment Duration:
1 IM injection. Participants will be followed for approximately 6 months post vaccination
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Stage 1 and Stage 2:
Sentinel Cohort: A female participant is eligible to participate if she is not pregnant or breastfeeding and:
Main and Booster Cohorts: A female participant is eligible to participate if she is not pregnant or breastfeeding and:
Able to attend all scheduled visits and to comply with all study procedures
Informed consent form has been signed and dated
Exclusion criteria
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
865 participants in 10 patient groups, including a placebo group
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Central trial contact
Trial Transparency email recommended (Toll free for US & Canada)
Data sourced from clinicaltrials.gov
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