A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)

Summary

This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \[6 dose levels\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant.

Eligibility

Age range

60+ years

Sex

All

Healthy volunteers

Yes

Interventions

• Biological
  RSV+HMPV vaccine

  RSV + HMPV Candidate Vaccine

• Biological
  Control Vaccine 3

  Control Vaccine 3

• Biological
  Control Vaccine 4

  Control Vaccine 4

• Biological
  Control Vaccine 2

  Control Vaccine 2

• Other
  Placebo

  Placebo

• Biological
  Control Vaccine 1

  Control Vaccine 1

Locations (17)