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Virus Therapy
RSV Vaccine for Respiratory Syncytial Virus (PICASSO Trial)
Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants 2 to <18 years of age at enrollment
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study duration (approximately 6 months)
Awards & highlights
PICASSO Trial Summary
This trial will study the safety and immune activity of a RSV vaccine (RSVpreF) in children 2-18 at high risk for RSV disease. It will include injections & blood tests over 6 months in the United States.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Specific side effects aren't listed but generally could include reactions at the injection site, fever, fatigue or allergic responses. Blood tests will monitor health changes post-vaccination.
PICASSO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 2 and 17 years old.
PICASSO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study duration (approximately 6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study duration (approximately 6 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Safety - The proportion of participants reporting Adverse Events (AEs)
Primary Safety - The proportion of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)
Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs)
+2 moreSecondary outcome measures
Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B
Secondary Immunogenicity - GMT of NTs for RSV A and RSV B
Secondary Immunogenicity - Median frequencies of RSV F antigen-specific CD4+ T cells expressing IFN gamma
+1 morePICASSO Trial Design
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVpreF 120 µg
2023
Completed Phase 1
~130
RSVpreF 60 µg
2023
Completed Phase 1
~130
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
PfizerLead Sponsor
4,582 Previous Clinical Trials
14,634,669 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,487 Previous Clinical Trials
11,811,544 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any RSV vaccine before or plan to during the study. My child may have been exposed through maternal immunization.My parent or guardian can sign the consent form for me.I have not been in any drug studies in the last 28 days.I have an autoimmune disease but it's not active or only have stable type 1 diabetes or hypothyroidism.I am a child at high risk of RSV due to a chronic condition like cystic fibrosis or asthma.I haven't taken strong immune system suppressing drugs or had radiation in the last 60 days.I haven't received any RSV monoclonal antibodies in the last 6 months.You have any medical or mental health condition or abnormal lab results that could make it risky for you to take part in the study. This includes having thoughts of hurting yourself or others in the past year or currently.I have a history of epilepsy, seizures, or neurological issues after vaccination.I am between 2 and 17 years old.I do not have a bleeding condition that makes injections unsafe for me.I haven't received any blood products or immunoglobulins in the last 28 days and don't plan to during the study.You have had a serious allergic reaction to a vaccine or any part of the study treatment.I am a child at high risk of RSV due to a chronic condition like asthma or Down syndrome.I am between 2 and 5 years old and have antibodies against RSV.
Research Study Groups:
This trial has the following groups:- Group 1: low dose in 5 to <18 years olds, with chronic high risk conditions
- Group 2: standard dose in 5 to < 18 years olds, with chronic high risk conditions
- Group 3: standard dose in 5 to <18 years olds, healthy
- Group 4: low dose in 2 to < 5 years olds
- Group 5: standard dose in 2 to < 5 years olds
- Group 6: low dose in 5 to <18 years olds, healthy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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