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.
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Presence of unsolicited systemic immediate adverse events (AEs)
Timeframe: Within 30 minutes after primary vaccination
Presence of solicited injection site or systemic reactions
Timeframe: Within 7 days after primary vaccination
Presence of unsolicited AEs
Timeframe: Within 28 days after vaccination
Presence of medically attended adverse events (MAAEs)
Timeframe: Up to 6 months after primary injection
Presence of serious adverse events (SAEs)
Timeframe: Up to 6 months after primary injection
Presence of adverse events of special interest (AESIs)
Timeframe: Up to 6 months after primary injection
Presence of related SAEs
Timeframe: Throughout study (approximately 24 months)
Presence of related AESIs
Timeframe: Throughout study (approximately 24 months)
Presence of fatal SAEs
Timeframe: Throughout study (approximately 24 months)
Presence of out-of-range biological test results
Timeframe: Within 7 days after vaccination
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
Timeframe: Day 1 and Day 29
hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
Timeframe: Day 1 and Day 29