RSV Vaccine for Respiratory Syncytial Virus
(PICASSO Trial)
Recruiting at 20 trial locations
PC
Overseen ByPfizer CT.gov Call Center
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Pfizer
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial is testing a new vaccine called RSVpreF in children aged 2 to under 18 years. The goal is to find a safe and effective dose that helps their immune system fight off the RSV virus. Participants will receive one injection and have several follow-up visits over a period of time.
Research Team
PC
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
Children aged 2 to <18 years at high risk of RSV disease can join this trial. They may have conditions like cystic fibrosis, asthma, lung issues, Down syndrome, neuromuscular diseases, cerebral palsy or congenital heart disease. For Phase 1 only: kids 2 to <5 must show prior RSV exposure. Parents/guardians must consent and help with study procedures.Inclusion Criteria
My parent or guardian can sign the consent form for me.
Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, and other study procedures, including collection of nasal swabs by participants' parent(s)/legal guardian(s) and by study staff when indicated
I am a child at high risk of RSV due to a chronic condition like cystic fibrosis or asthma.
See 3 more
Exclusion Criteria
I have not received any RSV vaccine before or plan to during the study. My child may have been exposed through maternal immunization.
Immunocompromised individuals associated with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination
I have not been in any drug studies in the last 28 days.
See 9 more
Treatment Details
Interventions
- RSVpreF (Virus Therapy)
Trial OverviewThe trial is testing a vaccine called RSVpreF for safety and immune response in two phases. Phase 1 determines the dose for later stages; all get one shot of the vaccine. In Phases 2/3, participants are randomly given either the vaccine or a placebo without knowing which they received.
Participant Groups
6Treatment groups
Experimental Treatment
Group I: standard dose in 5 to <18 years olds, healthyExperimental Treatment1 Intervention
standard dose (120 µg)
Group II: standard dose in 5 to < 18 years olds, with chronic high risk conditionsExperimental Treatment1 Intervention
standard dose (120 µg)
Group III: standard dose in 2 to < 5 years oldsExperimental Treatment1 Intervention
standard dose (120 µg)
Group IV: low dose in 5 to <18 years olds, with chronic high risk conditionsExperimental Treatment1 Intervention
low dose (60 µg)
Group V: low dose in 5 to <18 years olds, healthyExperimental Treatment1 Intervention
low dose (60 µg)
Group VI: low dose in 2 to < 5 years oldsExperimental Treatment1 Intervention
low dose (60 µg)
RSVpreF is already approved in Canada, Japan for the following indications:
Approved in Canada as Abrysvo for:
- LRTD caused by RSV in adults 60 years of age and older
- LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age
Approved in Japan as Abrysvo for:
- LRTD caused by RSV in adults 60 years of age and older
- LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University