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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
Must not have
Individuals with a history of epilepsy or other seizure disorders, or a history of seizures and/or other neurological complications following vaccination
Receipt of investigational or approved monoclonal antibodies against RSV within 6 months before study intervention administration, or planned receipt throughout the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study duration (approximately 6 months)
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 2 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of epilepsy, seizures, or neurological issues after vaccination.
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I haven't received any RSV monoclonal antibodies in the last 6 months.
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I haven't received any blood products or immunoglobulins in the last 28 days and don't plan to during the study.
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I haven't taken strong immune system suppressing drugs or had radiation in the last 60 days.
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I have not been in any drug studies in the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study duration (approximately 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study duration (approximately 6 months) for reporting.

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 more
Secondary 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 more

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Vaccines like RSVpreF work by exposing the immune system to a form of the Respiratory Syncytial Virus (RSV) or its components, which helps the body recognize and remember the virus. This enables the immune system to respond more quickly and effectively if exposed to the actual virus, preventing severe respiratory illness, reducing hospitalizations, and limiting the spread of RSV. This approach is particularly important for protecting vulnerable populations such as young children.

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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
4,595 Previous Clinical Trials
12,868,642 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,045,251 Total Patients Enrolled

Media Library

RSVpreF (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05900154 — Phase 1
Respiratory Syncytial Virus Research Study Groups: low dose in 5 to <18 years olds, with chronic high risk conditions, standard dose in 5 to < 18 years olds, with chronic high risk conditions, standard dose in 5 to <18 years olds, healthy, low dose in 2 to < 5 years olds, standard dose in 2 to < 5 years olds, low dose in 5 to <18 years olds, healthy
Respiratory Syncytial Virus Clinical Trial 2023: RSVpreF Highlights & Side Effects. Trial Name: NCT05900154 — Phase 1
RSVpreF (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05900154 — Phase 1
~64 spots leftby Jul 2025