RSV vaccine in children at high risk to see if it is safe and makes a strong immune response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional study evaluates the safety, tolerability, and immunogenicity of the RSVpreF vaccine versus placebo in pediatric participants at high risk for RSV disease. Enrollment begins with immunocompetent, RSV-experienced children before including immunocompromised participants, with separate cohorts by age and health status. Cohort 1 includes chronically ill children (split into 12 to under 18 and 5 to under 12 years), while Cohort 2 includes immunocompromised children (split similarly by age). Participants receive RSVpreF or placebo and are followed to assess immune response and safety signals. The trial is conducted at multiple sites to collect diverse data across pediatric populations.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Participants' age requirements for each study cohort at enrollment, respectively Cohort 1a (chronic medical conditions) 12 to \<18 years of age Cohort 1b (chronic medical conditions) 5 to \<12 years of age Cohort 2a (immunocompromising conditions) 12 to \<18 years of age Cohort 2b (immunocompromising conditions) 5 to \<12 years of age
* Participants depending on the study cohort requirements, will be considered by the investigator to be at high risk of LRTI-RSV based on the following disease characteristics and definitions:

Chronic medical conditions:

* Cystic fibrosis
* Medically treated asthma
* Other chronic respiratory diseases and malformations of the lung
* Trisomy 21 (Down syndrome)
* Neuromuscular disease
* Cerebral palsy
* Hemodynamically significant or symptomatic congenital heart disease
* Sickle cell disease
* Confirmed stable HIV disease defined as documented viral load \<50 copies/mL and CD4 count \>200 cells/mm3 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months

Immunocompromising conditions:

* Immunomodulatory therapy: Is on an active immunosuppressive (including cytotoxic) or immunomodulatory therapy at a stable dose. Patients taking steroids as monotherapy must be on a dose of at least 2 mg/kg/day or 20 mg/day or greater OR
* Primary immune deficiency: Has a diagnosed primary immunodeficiency disease OR
* Cellular therapy: Has received a bone marrow or stem cell transplant at least 6 months (180 days) prior to enrollment with adequate immune reconstitution for immunization in the investigator's opinion or has received chimeric antigen receptor T cell (CAR-T) therapy more than 90 days prior to enrollment OR
* Solid organ transplant: Has received a solid organ transplant at least 3 months prior and with no acute rejection episodes within 90 days prior to enrollment and is on ongoing immunosuppressive therapy OR
* End-stage renal disease: Has end-stage renal disease (ESRD) on hemodialysis (HD)
* Participants' weight must be:

Cohort 1a: ≥30.0 kg at enrollment Cohort 1b: ≥14.5 kg at enrollment Cohort 2a : ≥30 kg at enrollment Cohort 2b: ≥14.5 kg at enrollment

•The participant's parent(s)/legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and 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)

Key Exclusion Criteria:

* Applicable to Cohort 1 (a and b) participants only: Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination
* Applicable to Cohort 1 (a and b) participants only: Individuals with a history of autoimmune disease, past or present, requiring therapeutic intervention including, but not limited to, systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted
* 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 epilepsy or other seizure disorders that is uncontrolled/unstable, or a history of seizures and/or other neurological complications following vaccination
* History of Guillain-Barré syndrome and/or acute polyneuropathy without an underlying etiology.
* Individuals who are pregnant
* Any medical or psychiatric condition, including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study

Where it's running

• Duke Vaccine and Trials Unit
  Durham, North Carolina, United States Recruiting
• Cincinnati Children's Hospital Medical Center Vaccine Research Center
  Cincinnati, Ohio, United States Recruiting
• Senders Pediatrics
  South Euclid, Ohio, United States Recruiting
• Seattle Childrens Research Institute
  Seattle, Washington, United States Recruiting
• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting
• Maebashi Red Cross Hospital
  Maebashi, Gunma, Japan Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• RSV vaccine safety and immune response in lung transplant patients vs. healthy adults

  This study tests how well the RSV vaccine works and how safe it is in people who have had a lung transplant compared with healthy adults.

  Recruiting Phase 4 Seoul National University Hospital · Seoul, Jongno-Gu · NCT07895394

• Revaccination with RSVpreF in Immunocompromised Adults

  This study tests whether giving an RSVpreF vaccine shot again at about 1, 2, and 3 years is safe and can still provoke an immune response in adults who are immunocompromised.

  Recruiting at 13 sites Phase 3 Pfizer · Los Angeles, California and 16 other locations · NCT07768345

• Vaccine candidates for RSV and hMPV in older adults

  This study tests whether mRNA-1365 and related vaccine profiles are safe and able to trigger an immune response in healthy older adults.

  Recruiting at 2 sites Phase 1 ModernaTX, Inc. · Québec, Quebec and 9 other locations · NCT07764237

• YKYY025 Injection safety and immune response test in adults

  This phase 1 study tests whether YKYY025 is safe and prompts an immune response in healthy adults.

  Recruiting Phase 1 Youcare Pharmaceutical Group Co., Ltd. · Anning, Yunnan · NCT07694557

• RSVpreF vaccine in adults: safety and immune response in India

  A Phase 3 test of the RSVpreF vaccine vs placebo in adults 18 and older living in India to see if it is safe and produces an immune response.

  Recruiting at 13 sites Phase 3 Pfizer · Visakhapatnam, Andhra Pradesh and 12 other locations · NCT07653100

• Passive RSV antibody to protect Aboriginal and Torres Strait Islander infants

  This trial tests whether giving a single shot of the RSV antibody nirsevimab to Aboriginal and Torres Strait Islander infants around 6 months old can reduce RSV infections in the first year of life.

  Recruiting Phase 4 Menzies School of Health Research · Darwin, Northern Territory · NCT07578298

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.