A Study of Investigational RSV/hMPV Combination and Investigational hMPV Vaccines in Younger and Older Adults

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGlaxoSmithKline

About this trial

The aim of this study is to evaluate the safety, reactogenicity, and immune response of the different formulations of the investigational RSV/hMPV combination vaccine and investigational hMPV vaccine in younger and older adults.

Eligibility criteria

Qualifiers

Written informed consent obtained from the participant prior to performance of any study-specific procedure.

Participants who can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, ability to access and utilize a phone or other electronic communications).

Body Mass Index (BMI) between 18 kg/m² and 33 kg/m², inclusive.

A male or female between and including, 60 to 80 YOA at the time of the study intervention administration.

Disqualifiers

History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).

Any medical condition that in the judgment of the investigator would make IM injection unsafe.

Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, HIV) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).

Acute or unstable chronic pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.

Trial design

Treatments tested in this trial

  • RSV/hMPV_V low dose vaccine
  • RSV/hMPV_V medium dose vaccine
  • RSV/hMPV_V high dose vaccine
  • RSV/hMPV_W low dose vaccine
  • RSV/hMPV_W medium dose vaccine
  • RSV/hMPV_W high dose vaccine
  • RSV/hMPV_X low dose vaccine
  • RSV/hMPV_X medium dose vaccine
  • RSV/hMPV_X high dose vaccine
  • hMPV_Y low dose vaccine
  • hMPV_Y medium dose vaccine
  • hMPV_Y high dose vaccine
  • hMPV_Z low dose vaccine
  • hMPV_Z medium dose vaccine
  • hMPV_Z high dose vaccine
  • Control vaccine
  • Placebo

Treatment groups

1,456 Participants
are divided into 26 treatment groups

26

Treatment groups

See each treatment group below.

Sponsors and collaborators