A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
NCT ID: NCT05900154
Last Updated: 2025-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
128 participants
INTERVENTIONAL
2023-06-22
2024-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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standard dose in 5 to <18 years olds, healthy
standard dose (120 µg)
RSVpreF 120 µg
RSVpreF standard dose level
standard dose in 5 to < 18 years olds, with chronic high risk conditions
standard dose (120 µg)
RSVpreF 120 µg
RSVpreF standard dose level
standard dose in 2 to < 5 years olds
standard dose (120 µg)
RSVpreF 120 µg
RSVpreF standard dose level
low dose in 5 to <18 years olds, healthy
low dose (60 µg)
RSVpreF 60 µg
RSVpreF low dose level
low dose in 5 to <18 years olds, with chronic high risk conditions
low dose (60 µg)
RSVpreF 60 µg
RSVpreF low dose level
low dose in 2 to < 5 years olds
low dose (60 µg)
RSVpreF 60 µg
RSVpreF low dose level
Interventions
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RSVpreF 120 µg
RSVpreF standard dose level
RSVpreF 60 µg
RSVpreF low dose level
Eligibility Criteria
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Inclusion Criteria
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
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.
2 Years
17 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States
Stanford University Medical Center
Palo Alto, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Bio-Medical Research LLC
Miami, Florida, United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, United States
Velocity Clinical Research, New Orleans
Metairie, Louisiana, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Duke Vaccine And Trials Unit
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Innovo Research - Austin Regional Clinic
Austin, Texas, United States
Velocity Clinical Research, Austin
Austin, Texas, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Seattle Children's - Building Cure
Seattle, Washington, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2024-000422-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3671016
Identifier Type: -
Identifier Source: org_study_id
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