Respiratory Syncytial Virus (RSV)
Conditions
Brief summary
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.
Interventions
BIOLOGICALRSVpreF Vaccine
RSVpreF Vaccine
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participants ≥18 years of age who are/were immunocompromised at the time of initial RSVpreF vaccination, per study protocol, and will be grouped based on prior RSV vaccination history: * 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. * Participants should have a life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment. Key
Exclusion criteria
* 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. Refer to the study contact for further eligibility details.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants reporting local reactions | For up to 7 days after vaccination |
| Percentage of participants reporting systemic events | For up to 7 days after vaccination |
| Percentage of participants reporting adverse events | Through 1 month after vaccination |
| Percentage of participants reporting newly diagnosed chronic medical conditions | Through 12 months after vaccination |
| Percentage of participants reporting serious adverse events | Through 12 months after vaccination |
| Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titer (GMT) | Before vaccination, 1 month, 6 months and 12 months after vaccination |
| NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR) | Before vaccination, 1 month, 6 months and 12 months after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Seroresponse rate of NTs for RSV A and RSV B | 1 month after revaccination |
Countries
United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed