Palivizumab to prevent severe RSV in high-risk infants and young children

A Multicentre, Interventional, Phase IV, Open-label, Study to Evaluate the Safety of Palivizumab in Children Less Than 24 Months of Age With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease

This study will try monthly palivizumab injections in high-risk Indian infants and young children to prevent severe RSV lung disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: palivizumab
• Locations: 2 sites (Hyderabad and 1 other locations)
• Trial ID: NCT06851806 on ClinicalTrials.gov

What this trial studies

This is a Phase IV, prospective, open-label, multicenter safety study conducted at sites in India where all enrolled participants receive palivizumab 15 mg/kg by intramuscular injection once monthly for up to five doses. Safety assessments are performed before each injection, and an extra dose is given after cardiopulmonary bypass if a child undergoes cardiac surgery. Parents or guardians are contacted by telephone 30 days after the last dose for follow-up. The study documents tolerability and safety of palivizumab in the local high-risk pediatric population.

Who should consider this trial

Good fit: Ideal candidates are infants born at or before 35 weeks gestation who are under 6 months old, or children under 24 months who have required treatment for BPD in the last 6 months or who have haemodynamically significant congenital heart disease, with parental consent and ability to comply with visits.

Not a fit: Children who are hospitalized at enrollment, require mechanical ventilation or other major respiratory/cardiac support, or who do not meet the listed high-risk criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could reduce hospitalizations and severe lower respiratory tract infections from RSV among high-risk Indian infants and young children.

How similar studies have performed: Palivizumab has been shown in multiple prior studies to reduce RSV-related hospitalization in high-risk infants, so this post-marketing safety study in India follows an established and previously successful approach.

Eligibility criteria

Inclusion Criteria:

1. Participants at risk of severe RSV disease defined as fulfilling at least one of the following:

   1. Infants born ≤ 35 wGA and are \< 6 months of age at enrolment.
   2. Children \< 24 months of age at enrolment and requiring treatment for BPD within the last 6 months.
   3. Children \< 24 months of age and with haemodynamically significant CHD.
2. Written informed consent obtained from the participant's parent(s)/legal guardian and the participant's parent(s)/legal guardian is able to understand and comply with the requirements of the protocol including follow-up visits as judged by the investigator.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Hospitalisation at the time of enrolment, unless the discharge is expected within 30 days of the time of enrolment
2. Required mechanical ventilation (including continuous positive airway pressure) or other mechanical respiratory or cardiac support at the time of enrolment.
3. Anticipated cardiac surgery within 2 weeks after enrolment.
4. Anticipated survival of \< 6 months after enrolment in the trial.
5. Active LRTD, including RSV infection at the time of enrolment and/or study intervention administration.
6. Any fever (≥ 38.0°C) or acute illness within 7 days prior to investigational product administration.
7. Known history of evolving or unstable neurologic disorder.
8. Known history of unstable cardiac or respiratory status, including cardiac defects so severe that survival is not expected or for which cardiac transplantation is planned or anticipated.
9. Known allergy, including to immunoglobulin products, or history of allergic reaction.
10. Receipt of palivizumab or other RSV monoclonal antibodies or any RSV vaccine, including maternal RSV vaccination.
11. Receipt of any monoclonal or polyclonal antibody (for example, hepatitis B immune globulin, intravenous immunoglobulin) or anticipated use during the study.
12. Concurrent enrolment in another interventional study.
13. Children of employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
14. Judgment by the investigator that the participant should not participate in the study if the participant or the participant's parent/legal guardian is unlikely to comply with study procedures, restrictions, and requirements.

Where this trial is running

Hyderabad and 1 other locations

• Research Site — Hyderabad, India (Recruiting)
• Research Site — Pune, India (Not_yet_recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Respiratory Syncytial Virus; Phase IV