A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age (PICASSO)

A PHASE 1, OPEN-LABEL, AGE-DESCENDING, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE (RSVpreF) IN CHILDREN 2 TO <18 YEARS OF AGE

The purpose of this study is to learn about the safety and immune activity of the vaccine (called RSVpreF) in children 2 to <18 years of age.

This study will identify the dose level to be used in Phase 2/3 trials in this age cohort. All participants will receive one injection of RSVpreF. This study has four study visits, two in-clinic and two telehealth visits. Blood samples will be collected for testing. This study is about 6 months long for each participant and will be conducted in the United States.

Study Overview

• Status: Completed
• Conditions: RESPIRATORY SYNCYTIAL VIRUS (RSV)
• Intervention / Treatment: Biological: RSVpreF 120 µg; Biological: RSVpreF 60 µg

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - School of Medicine
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates
  • Florida
    • Miami, Florida, United States, 33144
      • Bio-Medical Research LLC
  • Iowa
    • Sioux City, Iowa, United States, 51106
      • Velocity Clinical Research, Sioux City
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Velocity Clinical Research, Metairie
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Omaha
  • New York
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, LLC
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke Vaccine and Trials Unit
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • South Euclid, Ohio, United States, 44121
      • Senders Pediatrics
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence
  • Texas
    • Austin, Texas, United States, 78726
      • ARC Clinical Research at Four Points
    • Austin, Texas, United States, 78759
      • Velocity Clinical Research, Austin
    • Cedar Park, Texas, United States, 78613
      • Velocity Clinical Research, Austin
  • Utah
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research, Salt Lake City
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital
    • Seattle, Washington, United States, 98101
      • Seattle Children's - Building Cure

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participants 2 to <18 years of age at enrollment

2. Participants 2 to <18 years of age should either be healthy or be considered by the investigator to be at high risk of RSV disease based on the presence of 1 of the following chronic medical conditions:

   • Cystic fibrosis
   • Medically treated asthma
   • Other chronic respiratory diseases and malformations of the lung
   • Down syndrome
   • Neuromuscular disease
   • Cerebral palsy
   • Hemodynamically significant or symptomatic congenital heart disease
3. All participants 2 to <5 years of age must be seropositive for RSV as confirmed by serology.
4. 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.
5. The participant's parent(s)/legal guardian is capable of giving signed informed consent as described in the protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written).

Exclusion Criteria:

1. Immunocompromised individuals associated with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
2. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
3. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
4. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
5. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
6. Individuals with a history of epilepsy or other seizure disorders, or a history of seizures and/or other neurological complications following vaccination.
7. Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation. Children who may have been exposed to investigational RSV vaccines through maternal immunization will be permitted.
8. Receipt of investigational or approved monoclonal antibodies against RSV within 6 months before study intervention administration, or planned receipt throughout the study.
9. Receipt of blood/plasma products or immunoglobulins within 28 days before study intervention administration, or planned receipt throughout the study.

10. Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study intervention administration, or planned receipt throughout the study.

    Note: Systemic corticosteroids are defined as those administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent (eg, for cancer or an autoimmune disease). Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted.

11. Participation in other studies involving study intervention within 28 days prior to study entry and/or for the duration of study participation.
12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: standard dose in 5 to <18 years olds, healthy; standard dose (120 µg)	Biological: RSVpreF 120 µg; RSVpreF standard dose level
Experimental: standard dose in 5 to < 18 years olds, with chronic high risk conditions; standard dose (120 µg)	Biological: RSVpreF 120 µg; RSVpreF standard dose level
Experimental: standard dose in 2 to < 5 years olds; standard dose (120 µg)	Biological: RSVpreF 120 µg; RSVpreF standard dose level
Experimental: low dose in 5 to <18 years olds, healthy; low dose (60 µg)	Biological: RSVpreF 60 µg; RSVpreF low dose level
Experimental: low dose in 5 to <18 years olds, with chronic high risk conditions; low dose (60 µg)	Biological: RSVpreF 60 µg; RSVpreF low dose level
Experimental: low dose in 2 to < 5 years olds; low dose (60 µg)	Biological: RSVpreF 60 µg; RSVpreF low dose level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety - The proportion of participants reporting local reactions	Local reactions include pain at injection site, redness and swelling reported on e-diaries.	Within 7 days following study administration intervention
Primary Safety - The proportion of participants reporting systemic reactions	Systemic reactions: fever, fatigue/tiredness, headache, muscle pain, joint pain, vomiting, diarrhea reported on e-diaries.	Within 7 days following study administration intervention
Primary Safety - The proportion of participants reporting Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs include both serious and non-serious adverse events.	Through 1 month following study administration intervention
Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs)	SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Throughout the study duration (approximately 6 months)
Primary Safety - The proportion of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs)	An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects.	Throughout the study duration (approximately 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Immunogenicity - GMT of NTs for RSV A and RSV B	RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs).	At each blood sampling visit (Day 1 before vaccination and 1-month after vaccination)
Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B	RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Fold Rise (GMFR).	At each blood sampling visit (Day 1 before vaccination and 1-month after vaccination)
Secondary Immunogenicity - Median frequencies of RSV F antigen-specific CD4+ T cells expressing IFN gamma	As measured at the central laboratory, RSV F antigen-specific CD4+ T cells secreting IFN gamma	At each blood sampling visit (Day 1 before vaccination and 1-month after vaccination)
Secondary Immunogenicity - Median frequencies of RSV F antigen-specific CD4+ T cells expressing IL-4	As measured at the central laboratory, RSV F antigen-specific CD4+ T cells secreting IL-4	At each blood sampling visit (Day 1 before vaccination and 1-month after vaccination)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; RSV; Respiratory infection; RESPIRATORY SYNCYTIAL VIRUS; Respiratory illness; RSV vaccine
• Other Study ID Numbers: C3671016; 2022-503134-32-00 (Registry Identifier: CTIS (EU)); 2022-503134-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No