A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Immunocompromised Adults
ConditionRespiratory Syncytial Virus (RSV)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer
About this trial
The purpose of this phase 3 study is to learn the safety, tolerability and immunogenicity of revaccination with RSVpreF at approximately 1-, 2-, and 3-year intervals to inform the revaccination interval in immunocompromised adults.
This study is seeking participants who are 18 years of age and older and will be grouped based on prior RSV vaccination history. Participants are required to be immunocompromised per study protocol.
All participants in this study will receive 1 shot to their arm of a RSVPreF vaccine.
Participants will take part in this study for about 12 months and will need to visit the clinical study site at least 4 times.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Group 1 will include participants naïve to any RSV vaccine.
Group 2 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 1 year (9 to 15 months) prior to enrollment.
Group 3 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 2 years (21 to 27 months) prior to enrollment.
Group 4 will include participants who previously received 2 doses of RSVpreF in Study C3671023 Substudy B approximately 3 years (36 to 42 months) prior to enrollment.
Disqualifiers
Prior history of any subtype of Guillain-Barré Syndrome (GBS) of any etiology.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any components of the study intervention(s).
Participants with a history of transplant rejection, or PTLD, or participants who have had treatment for these conditions, within 90 days prior to study enrollment or suspected chronic humoral or cellular rejection.
Receipt of B-cell depleting therapies within 180 days prior to initial study vaccination.
Trial design
Design model
Parallel
Treatments tested in this trial
RSVpreF Vaccine
Biological/VaccineRSVpreF Vaccine
Treatment groups
440 Participants
are divided into 4 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of participants reporting local reactions
Time frame
For up to 7 days after vaccination2
Percentage of participants reporting systemic events
Time frame
For up to 7 days after vaccination3
Percentage of participants reporting adverse events
Time frame
Through 1 month after vaccination4
Percentage of participants reporting newly diagnosed chronic medical conditions
Time frame
Through 12 months after vaccinationSecondary outcomes
1
Seroresponse rate of NTs for RSV A and RSV B
Time frame
1 month after revaccination Source ClinicalTrials.gov