Respiratory Syncytial Virus (RSV) Clinical Trial
Official title:
A Phase I Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of an RSV-F Protein Nanoparticle Vaccine, With or Without Aluminum Adjuvant, and Co-administered With a Licensed Inactivated Influenza Vaccine, in Healthy Subjects ≥ 60 Years of Age.
Up to 220 eligible subjects will be enrolled into one of five treatment groups. It is
anticipated that some of the randomized study subjects may not complete the study; subjects
who withdraw or are discontinued, will not be replaced. Randomization will be stratified by
age (60 to <75 years and ≥ 75 years) in order to distribute the proportion of such persons
in each age group equally across treatment groups.
Treatments will comprise a single IM dose of a placebo or RSV-F protein nanoparticle vaccine
on Day 0, with concurrent IM immunization with a licensed inactivated influenza vaccine. A
rescue dose of the licensed TIV will be provided to subjects in all groups except the
placebo group on Day 28, the placebo group will receive saline. For each subject, study
follow-up will span approximately one year from the first immunization (on Day 0) for all
subjects.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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