Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with seasonal inactivated influenza vaccine (SIIV).
Full description
The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with SIIV. Healthy male and female subjects divided into 2 age groups (18-49 years of age and 50-85 years of age in the sentinel cohort and 18-49 years of age and 65-85 years of age in the expanded cohort) will be enrolled. Age groups will run in parallel. Subjects in the sentinel cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo. Subjects in the expanded cohort in each age group will receive one of two RSV vaccine formulations at one of 3 antigen dose levels with and without SIIV.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,235 participants in 20 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal