Clinical trial NCT05900154: A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: RESPIRATORY SYNCYTIAL VIRUS (RSV)
Keywords: RESPIRATORY SYNCYTIAL VIRUS
RSV
RSV vaccine
Respiratory illness
Respiratory infection
Pediatric
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is an open-label dose-finding study. A single dose of RSVpreF 120 µg will be given to 40 participants in the 5 to \<18 age group first. Upon safety review and approval, a dose of 60 µg will be given to 20 participants in the 2 to \<5 age group. If, 60 µg is safe, another 20 participants in the 2 to \<5- age group will receive the 120-µg dose. Approximately 60 to 120 participants are expected to be enrolled.
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
timeFrame: Day 1 through Day 7 after Vaccination
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
timeFrame: Day 1 through Day 7 after Vaccination
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
timeFrame: Within 1 month post Vaccination
measure: Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study
timeFrame: Within 6 months post Vaccination
measure: Percentage of Participants Reporting Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study
timeFrame: Within 6 months post Vaccination
Secondary outcomes:
measure: Geometric Mean Titer of the Neutralizing Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination
timeFrame: Before vaccination and 1 month after vaccination
measure: Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination
timeFrame: From before vaccination to 1 month after vaccination
measure: Median Frequencies of RSV F Antigen-Specific Cluster of Differentiation 4 (CD4+) Thymus-Derived Lymphocytes (T) Cells Expressing Interferon (IFN) Gamma and Interleukin-4 (IL-4) Before Vaccination and 1 Month After Vaccination
timeFrame: Before vaccination and 1 Month after vaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - School of Medicine
state: Alabama
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Miami
country: United States
facility: Bio-Medical Research LLC
state: Florida
city: Sioux City
country: United States
facility: Velocity Clinical Research, Sioux City
state: Iowa
city: Metairie
country: United States
facility: Velocity Clinical Research, New Orleans
state: Louisiana
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Durham
country: United States
facility: Duke Vaccine And Trials Unit
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Austin
country: United States
facility: Innovo Research - Austin Regional Clinic
state: Texas
city: Austin
country: United States
facility: Velocity Clinical Research, Austin
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Seattle
country: United States
facility: Seattle Children's - Building Cure
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: