Safety of RSV Preventive Monoclonal Antibody

NCT07158814 | Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro00117888
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 6

Brief Summary

This is a prospective, randomized, open-label clinical trial to evaluate the safety of administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other vaccines at separate visits (Visits 1 and 2).

Conditions

Fever; Adverse Event Following Immunisation

Keywords

Respiratory Syncytial Virus (RSV); Fever Following Immunization; RSV Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Fever Following Immunization

  Number of infants with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.

  Up to 2 days post administration

Secondary Outcomes (4)

• Number of Participants with Grade 2 and/or 3 Fever Following Visit 1

  Up to 2 days post administration

• Number of Participants with Grade 2 and/or 3 Fever Following Visit 2

  Up to 2 days post administration

• The Number of Participants with At Least One Serious Adverse Event

  Up to 98 days post administration

• The Number of Participants with At Least One Adverse Event of Special Interest

  Up to 98 days post administration

Study Arms (2)

Simultaneous Immunization

EXPERIMENTAL

The simultaneous immunization group will receive routine childhood vaccinations and respiratory syncytial virus (RSV) preventive monoclonal antibody at Visit 1.

Drug: Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody

Sequential Immunization

EXPERIMENTAL

The sequential immunization group will receive routine childhood vaccinations at Visit 1, followed by respiratory syncytial virus (RSV) preventive monoclonal antibody at Visit 2.

Drug: Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody

Interventions

Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody DRUG

ACIP Recommended Preventive Monoclonal Antibody

Also known as: Nirsevimab, Beyfortus

Sequential Immunization; Simultaneous Immunization

Eligibility Criteria

• Age: 6 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants ≥ 6 weeks to \<30 weeks of age at the time of enrollment
• Infants eligible for RSV monoclonal antibody and at least one routine childhood vaccine in outpatient clinic
• The parent/legal guardian must be willing and capable of providing permission for their infant to participate through the written informed consent process
• Parent/legal guardian must be able to read and comprehend English or Spanish
• The parent/legal guardian must be available for follow-up study contact by telephone from enrollment to completion of the study period
• The parent/legal guardian must agree to sign a medical record release for the infant so that study personnel may obtain medical information about the infant's health (if needed)
• The parent/legal guardian must be willing to delay their child's receipt of RSV monoclonal antibody up to two weeks from the scheduled date and to return for a second visit to receive the deferred RSV monoclonal antibody

You may not qualify if:

• Known contraindication or precaution to RSV monoclonal antibody or other routine vaccines being administered
• Received any vaccine within 14 days prior to enrollment and the first immunization day in this study
• Known previous receipt of RSV monoclonal antibody
• Received any experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to immunization in this study or expects to receive an experimental/investigational agent within the follow-up time period (8 days after the second immunization in this study)
• A moderate to severe acute illness and/or a reported temporal temperature greater than or equal to 100.4°F (38.0°C) within 48 hours prior to enrollment or a temporal temperature (measured by temporal artery thermometer) greater than or equal to 100.4°F (38.0°C) at the time of enrollment. (This may result in a temporary delay of immunization)
• Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 48 hours prior to enrollment (This may result in a temporary delay of immunization)
• Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol
• Anyone who is a first-degree relative of any research study personnel
• The infant is born to a mother who received a maternal RSV immunization more than 14 days prior to delivery and is not eligible for RSV preventative monoclonal antibody
• Bleeding disorder or condition associated with prolonged bleeding that would present as a safety risk per opinion of the investigator
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the vaccines or RSV monoclonal antibody
• Has an active neoplastic disease, or a history of any hematologic malignancy
• History of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of a vaccine administered on the day of study enrollment
• Immunosuppression as a result of an underlying illness or treatment or use of anti-cancer chemotherapy or radiation therapy since birth
• For infants receiving DTaP vaccine (alone or combination vaccine): Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures), not attributable to another identifiable cause, within 7 days of administration of previous dose of DTaP

Sponsors & Collaborators

• Duke University: lead
• Centers for Disease Control and Prevention: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Columbia University: collaborator
• Emory University: collaborator
• Kaiser Permanente: collaborator

Study Sites (6)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Centers for Disease Control and Prevention

Atlanta, Georgia, 30333, United States

ACTIVE NOT RECRUITING

Columbia University

New York, New York, 10027, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Fever

Interventions

nirsevimab

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael J Smith, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Smith, MD

CONTACT

919 684 6335; michael.j.smith@duke.edu

Emily A Randolph, MBA

CONTACT

919 385 5785; emily.randolph@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 8, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)