Adult, Healthy Participants
Conditions
Keywords
RSV vaccine, Respiratory Syncytial Virus (RSV)
Brief summary
The purpose of this study is to learn about the safety, tolerability, and immune response of the RSVpreF vaccine in healthy older adults. Participants will take part in this study for about 6 months. The study will include people in China and the United States. In China, participants will receive either RSVpreF or placebo. A placebo is a dummy vaccine with no active ingredient, but it looks just like the vaccine being studied. In the United States, all participants will receive RSVpreF. Researchers will check for any reactions. They will also check blood test results to learn how the body responds to the vaccine. The main questions the study aims to answer are: * What local reactions and systemic events (body-wide symptoms) do participants have after a RSVpreF vaccination? * What medical problems do participants have after a RSVpreF vaccination? * Researchers will compare antibody levels from blood tests between the China cohort and the US cohort. An antibody is a substance in the body that try to fight off an infection or foreign substance. Participants will: * Have a screening visit to make sure they qualify for the study (participants in China will have this visit before the day of vaccination) * Receive the RSVpreF vaccination (or a placebo injection if in the China cohort) once at Visit 1. * Have a telephone or clinic visit 1 week later to assess local reactions and systemic events. * Have a clinic visit a month after vaccination for a checkup and tests. * Have a telephone or clinic visit 6 months after vaccination for a health check. * Have a blood test at screening (if in the China cohort only), on the day of vaccination and 1 month after vaccination.
Interventions
BIOLOGICALRSVpreF
Single Dose
OTHERPlacebo
Single Dose
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The China cohort will receive the study interventions double-blinded and will be randomized in a ratio of 2:1 to receive either RSVpreF or placebo. The US cohort will receive the study intervention open-label in a single-arm design and will receive RSVpreF.
Intervention model description
Phase 3, interventional, parallel assignment
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria * Participants 60 years of age or older at enrolment. * Healthy participants, or participants with stable long-term medical conditions, if the investigator decides they can take part. * Adults who can walk and live in the community or in assisted-living/long-term care settings with minimal help. * Participants who can give signed informed consent and follow study visits and procedures, including the 7-day electronic diary and blood tests. Key
Exclusion criteria
* Confirmed RSV infection 180 days or less before study vaccination. * Any past history of Guillain-Barré syndrome. * Severe reaction to a vaccine or severe allergy to a study vaccine component or related vaccine. * Serious or unstable medical condition that the investigator believes makes the study unsafe. * Immunocompromised status, based on medical history and/or examination. * Previous receipt of any licensed or investigational RSV vaccine or RSV preventive monoclonal antibody, or planned receipt during the study. Please refer to the study contact for further eligibility details Contacts/Locations Central Contact Person: Pfizer CT.gov Call Center Telephone: 1-800-718-1021 Email: ClinicalTrials.gov\_Inquiries@pfizer.com
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants reporting local reactions: pain at the injection site, redness, and swelling | Within 7 days after vaccination |
| Percentage of participants reporting systemic events: fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain | Within 7 days after vaccination |
| Percentage of participants reporting adverse events (AEs) | Within 1 month after vaccination |
| Percentage of participants reporting serious adverse events (SAEs) | Through 6 months after vaccination |
| Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) | Through 6 months after vaccination |
| RSV A and RSV B neutralizing antibody levels before vaccination and 1 month after vaccination | Before vaccination and 1 month after vaccination |
| Geometric mean fold rise in RSV A and RSV B neutralizing antibody levels from before vaccination to 1 month after vaccination | Before vaccination to 1 month after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Seroresponse rate for RSV A and RSV B neutralizing antibody levels | 1 month after vaccination |
Countries
China, United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed