Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age

    Not Recruiting
  • participants needed
  • sponsor
Updated on 24 September 2022
Accepts healthy volunteers


The purpose of this study is to assess the safety and immunogenicity of RSVpreF when coadministered with SIIV compared to sequential administration of the vaccines when given 1 month apart (SIIV followed by RSVpreF). Additionally, the study will contribute data supporting the development of RSVpreF as a prophylactic vaccine against RSV disease in infants through maternal immunization and in older adults through active vaccination.


This Phase 3, multicenter, parallel-group, placebo-controlled, randomized, double-blind study will be conducted in Australia and/or another southern hemisphere country.

Healthy adults ≥65 years of age will be randomized 1:1 to either the coadministration group (RSVpreF + SIIV)/placebo or the sequential-administration group (placebo + SIIV)/RSVpreF. This study design intends to use a single lot of NIP SIIV that is specifically indicated for use in adults ≥65 years of age.

There are 3 scheduled study visits each 1 month apart. To assess immunogenicity, 30 mL blood will be collected prior to vaccination at Visit 1 and Visit 2, and at Visit 3.

Local reactions (redness, swelling, and pain at the injection site) occurring at the RSVpreF or placebo injection site (left deltoid) and systemic events (fever, headache, fatigue, nausea, vomiting, diarrhea, muscle pain, and joint pain) occurring within 7 days after each vaccination visit (Visit 1 and Visit 2) will be prompted for and collected daily by the participant in an e-diary device or smartphone app. SIIV injection site reactions will not be routinely collected in the e-diary.

AEs and SAEs will be collected from the signing of informed consent through Visit 3.

Condition Respiratory Syncytial Virus
Treatment Placebo, RSVpreF Vaccine, Seasonal Inactivated Influenza Vaccine
Clinical Study IdentifierNCT05301322
Last Modified on24 September 2022

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note