Prevention of RSV-associated lower respiratory tract illness in children 2-18 years of age by active immunization MedDRA version: 21.1 Level: LLT Classification code 10066742 Term: Respiratory syncytial virus infection prophylaxis System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Abrysvo
Product Name: Abrysvo
Product Code: PF-06928316
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: RSV subgroup A stabilized prefusion F antige
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participants 2 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: • Local and Systematic reactions (Within 7 days following study administration intervention) • AEs and SAEs (Throughout the study duration (approximately 6 months)) • NDCMCs (Throughout the study duration (approximately 6 months)) ;Main Objective: To describe the safety and tolerability of RSVpreF at each dose level in children 5 to < 18 years of age and children 2 to <5 years of age.;Secondary Objective: 1) To describe the immune response elicited by RSVpreF at each dose level in children 5 to <18 years of age and children 2 to <5 years of age. 2) To describe the cell-mediated immune response in children 5 to <18 years of age and children 2 to <5 years of age.;Primary end point(s): 1) Primary Safety - The Percentage of participants reporting local reactions 2) Primary Safety - The Percentage of participants reporting systemic reactions 3) Primary Safety - The proportion of participants reporting Adverse Events (AEs) 4) Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs) 5) Primary Safety - The proportion of participants reporting Newly Diagnosed Chronic Medical Conditions (NDCMCs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Secondary Immunogenicity - GMT of NTs for RSV A and RSV B 2) Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B 3) Secondary Immunogenicity - Median frequencies of RSV F antigen-specific CD4+ T cells expressing IFN gamma 4) Secondary Immunogenicity - Median frequencies of RSV F antigen-specific CD4+ T cells expressing IL-4;Timepoint(s) of evaluation of this end point: At each blood sampling visit (Day 1 before vaccination and 1-month after vaccination) | — |
Countries
United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc.
Outcome results
None listed