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

NCT05900154 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: C36710162024-000422-17
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 17

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.

Conditions

RESPIRATORY SYNCYTIAL VIRUS (RSV)

Keywords

RESPIRATORY SYNCYTIAL VIRUS; RSV; RSV vaccine; Respiratory illness; Respiratory infection; Pediatric

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination

  Local reactions were collected in the electronic diary (e-diary) from Day 1 through Day 7 after vaccination. Local reactions included pain at injection site, redness, and swelling. For participants greater than or equal to (\>=) 2 years to \<12 years of age, redness and swelling were graded as mild: 0.5 to 2.0 centimeter (cm), moderate: \>2.0 to 7.0 cm, and severe: \> 7 cm; for participants \>=12 years of age, mild: \> 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, and severe: \>10 cm. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

  Day 1 through Day 7 after Vaccination

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination

  Systemic events included fever, fatigue, headache, vomiting, diarrhea, muscle pain and joint pain and were recorded by participants using e-diary. Fever: oral temperature \>= 38.0 degree Celsius (deg C) and categorized as \>=38.0 to 38.4 deg C (mild), \>38.4 to 38.9 deg C (moderate), and \>38.9 to 40.0 deg C (severe). Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), and severe (prevented daily routine activity). Vomiting was graded mild: 1-2 times in 24 hours (h), moderate: \>2 times in 24h, and severe: required intravenous hydration. Diarrhea was graded mild: 2-3 loose stools in 24h, moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h.

  Day 1 through Day 7 after Vaccination

• Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

  AE was defined as any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. AEs included serious and all non-serious AE. SAEs were defined as AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was congenital anomaly or birth defect; was suspected transmission via Pfizer product of infectious agent, pathogenic or nonpathogenic or was considered to be an important medical event. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were included.

  Within 1 month post Vaccination

• Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability or incapacity; was a congenital anomaly or birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event.

  Within 6 months post Vaccination

• Percentage of Participants Reporting Newly Diagnosed Chronic Medical Condition (NDCMCs) Throughout the Study

  An NDCMC was defined as a disease or medical condition, which was not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  Within 6 months post Vaccination

Secondary Outcomes (3)

• Geometric Mean Titer of the Neutralizing Titers for RSV A and RSV B Before Vaccination and 1 Month After Vaccination

  Before vaccination and 1 month after vaccination

• Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B From Before Vaccination to 1 Month After Vaccination

  From before vaccination to 1 month after vaccination

• 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

  Before vaccination and 1 Month after vaccination

Study Arms (6)

standard dose in 5 to <18 years olds, healthy

EXPERIMENTAL

standard dose (120 µg)

Biological: RSVpreF 120 µg

standard dose in 5 to < 18 years olds, with chronic high risk conditions

EXPERIMENTAL

standard dose (120 µg)

Biological: RSVpreF 120 µg

standard dose in 2 to < 5 years olds

EXPERIMENTAL

standard dose (120 µg)

Biological: RSVpreF 120 µg

low dose in 5 to <18 years olds, healthy

EXPERIMENTAL

low dose (60 µg)

Biological: RSVpreF 60 µg

low dose in 5 to <18 years olds, with chronic high risk conditions

EXPERIMENTAL

low dose (60 µg)

Biological: RSVpreF 60 µg

low dose in 2 to < 5 years olds

EXPERIMENTAL

low dose (60 µg)

Biological: RSVpreF 60 µg

Interventions

RSVpreF 120 µg BIOLOGICAL

RSVpreF standard dose level

standard dose in 2 to < 5 years olds; standard dose in 5 to < 18 years olds, with chronic high risk conditions; standard dose in 5 to <18 years olds, healthy

RSVpreF 60 µg BIOLOGICAL

RSVpreF low dose level

low dose in 2 to < 5 years olds; low dose in 5 to <18 years olds, healthy; low dose in 5 to <18 years olds, with chronic high risk conditions

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants 2 to \<18 years of age at enrollment
• 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
• All participants 2 to \<5 years of age must be seropositive for RSV as confirmed by serology.
• 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.
• 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).

You may not qualify if:

• Immunocompromised individuals associated with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• 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.
• 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.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Individuals with a history of epilepsy or other seizure disorders, or a history of seizures and/or other neurological complications following vaccination.
• 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.
• Receipt of investigational or approved monoclonal antibodies against RSV within 6 months before study intervention administration, or planned receipt throughout the study.
• Receipt of blood/plasma products or immunoglobulins within 28 days before study intervention administration, or planned receipt throughout the study.
• 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.
• Participation in other studies involving study intervention within 28 days prior to study entry and/or for the duration of study participation.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (17)

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama, 35233, United States

Location

Stanford University Medical Center

Palo Alto, California, 94304, United States

Location

Peninsula Research Associates

Rolling Hills Estates, California, 90274, United States

Location

Bio-Medical Research LLC

Miami, Florida, 33144, United States

Location

Velocity Clinical Research, Sioux City

Sioux City, Iowa, 51106, United States

Location

Velocity Clinical Research, New Orleans

Metairie, Louisiana, 70006, United States

Location

Velocity Clinical Research, Omaha

Omaha, Nebraska, 68134, United States

Location

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

Location

Duke Vaccine And Trials Unit

Durham, North Carolina, 27703, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Senders Pediatrics

South Euclid, Ohio, 44121, United States

Location

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States

Location

Innovo Research - Austin Regional Clinic

Austin, Texas, 78726, United States

Location

Velocity Clinical Research, Austin

Austin, Texas, 78759, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Seattle Children's - Building Cure

Seattle, Washington, 98101, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Links

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

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

18007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is open-label therefore no blinding requirements are in place since all participants will receive RSVPreF.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: June 22, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)