Healthy Volunteers Clinical Trial
Official title:
A Phase I/IIa, Randomized, Observer-blind Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an RSV/hMPV Vaccine, in Adult Participants Aged 60 Years and Older
The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.
Study duration per participant: 12 months for the Sentinel and Main Cohorts and 24 months overall for the subset of participants enrolled in the Booster Cohort. Treatment Duration: Sentinel Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination. Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination. Booster Cohort: 1 IM injection 12 months after the primary vaccination (Main Cohort). Participants will be followed for 12 months after administration of the booster dose. ;
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