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

RESPIRATORY SYNCYTIAL VIRUS (RSV) Clinical Trial

— PICASSO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05900154
• Other study ID #: C3671016
• Secondary ID: 2022-503134-32
• Status: Completed
• Phase: Phase 1
• Start date: June 22, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• RESPIRATORY SYNCYTIAL VIRUS (RSV)

Intervention

Biological:
• RSVpreF 120 µg
RSVpreF standard dose level
• RSVpreF 60 µg
RSVpreF low dose level

Locations

Country	Name	City	State
United States	ARC Clinical Research at Four Points	Austin	Texas
United States	Velocity Clinical Research, Austin	Austin	Texas
United States	University of Alabama at Birmingham - School of Medicine	Birmingham	Alabama
United States	Velocity Clinical Research, Austin	Cedar Park	Texas
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Duke Vaccine And Trials Unit	Durham	North Carolina
United States	Velocity Clinical Research, Providence	East Greenwich	Rhode Island
United States	Velocity Clinical Research, Metairie	Metairie	Louisiana
United States	Bio-Medical Research LLC	Miami	Florida
United States	Velocity Clinical Research, Omaha	Omaha	Nebraska
United States	Stanford University Medical Center	Palo Alto	California
United States	Rochester Clinical Research, LLC	Rochester	New York
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	Seattle Children's - Building Cure	Seattle	Washington
United States	Seattle Children's Hospital	Seattle	Washington
United States	Velocity Clinical Research, Sioux City	Sioux City	Iowa
United States	Senders Pediatrics	South Euclid	Ohio
United States	Velocity Clinical Research, Salt Lake City	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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	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	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	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	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)

External Links

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