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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 below
Select...
I am between 2 and 17 years old.

PICASSO Trial 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

PICASSO 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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,746 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,914 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA authorized usage of RSVpreF at its recommended dose?

"With regards to RSVpreF's standard dosage, our team at Power has evaluated the safety rating as a 3. This is based on Phase 3 trial data that suggests efficacy and multiple rounds of evidence confirming its safety."

Answered by AI

How many participants are being researched in this clinical trial?

"For the purposes of this research, 1980 qualifying patients are necessary. Potential participants may visit two trial sites in particular: Bio-Medical Research LLC located in Miami, Florida and Velocity Clinical Research, Sioux City situated in Iowa's Sioux City."

Answered by AI

Is it possible for me to join the clinical experiment?

"Eligibility for this trial requires a diagnosis of respiratory syncytial virus and ages between 2-17 years old. The project is aiming to recruit 1980 participants in total."

Answered by AI

Is the research project currently seeking new participants?

"Per the details available on clinicaltrials.gov, this medical trial is currently welcoming participants. It was originally posted on June 22nd 2023 and last modified on July 5th 2023."

Answered by AI

Does this clinical trial provide the opportunity for elderly individuals to participate?

"Per the entry requirements, this clinical trial is only open to patients between 2 and 17 years of age. Separate trials are available for those below 18 or above 65."

Answered by AI

How many medical institutions are participating in this research project?

"Presently, this clinical trial is enrolling participants from 12 separate medical centres. These are situated in cities such as Miami, Sioux City and Metairie alongside a further 9 locations. For the convenience of patients wishing to take part, it is recommended that they select the facility nearest them thus minimizing their travelling requirements."

Answered by AI

What are the primary goals of this experiment?

"According to the clinical trial's sponsor, Pfizer, the primary objective being measured over a 6-month time frame is gauging participants' local reactions. Secondary outcomes include: RSV A and B prefusion F-binding IgG expressed as Geometric Mean Fold Rise (GMFR), RSV A and B neutralizing titers (NT) expressed as GMFR, and NTs for RSV A and B expressed as Geometric Mean Titers (GMTs)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
2023. "A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05900154.
~70 spots leftby Apr 2025
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