A Study to Learn About the Safety and Immune Responses of RSVpreF in Older Adults
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age60+
SponsorPfizer
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
RSVpreF
Biological/VaccineSingle Dose
Placebo
Other interventionSingle Dose
Treatment groups
600 Participants
are divided into 3 treatment groupsGroup A: China PlaceboPlacebo comparator 1 intervention
Group B: China RSVpreFActive comparator 1 intervention
Group C: US RSVpreFActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants reporting local reactions: pain at the injection site, redness, and swelling
Time frame
Within 7 days after vaccination2
Percentage of participants reporting systemic events: fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain
Time frame
Within 7 days after vaccination3
Percentage of participants reporting adverse events (AEs)
Time frame
Within 1 month after vaccination4
Percentage of participants reporting serious adverse events (SAEs)
Time frame
Through 6 months after vaccinationSecondary outcomes
1
Seroresponse rate for RSV A and RSV B neutralizing antibody levels
Time frame
1 month after vaccination Source ClinicalTrials.gov