Recruiting

RSV with Vaccines

Sponsor:

Duke University

Code:

NCT07158814

Conditions

Fever

Adverse Event Following Immunisation

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody

Study Details

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

Study ID

NCT07158814

Start date

Oct 2, 2025

Status verified date

Mar, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Planned receipt of a prophylactic antipyretic medication on the day of and/or days following immunization. This exclusion does not apply if the parent/legal guardian indicates they might administer antipyretics after immunization in response to fever or pain
  • 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
  • Intention to receive non-live or live vaccines during the 4 weeks after Visit 1; vaccines may be administered after enrollment if deemed a personal or public health priority by the health care provider caring for this patient or the study team
  • Long term (at least 14 days of prednisone 2 mg/kg/day or equivalent other glucocorticoid) use of any parenteral steroids within the 6 months prior to enrollment (topical, nasal and inhaled steroids are allowed)

Study Design

Enrollment

524 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Simultaneous Immunization

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

experimental: Sequential Immunization

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

Interventions

Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody

ACIP Recommended Preventive Monoclonal Antibody

Primary outcome measure

  • Number of Participants with Fever Following Immunization [ Time Frame: Up to 2 days post administration ]

Central Contacts and Locations

Central contacts

Michael J Smith, MD

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

Emily A Randolph, MBA

919 385 5785emily.randolph@duke.edu

Locations

Kaiser Permanente Northern California

Recruiting

Oakland, California, United States, 94612

Contacts

Nicola Klein, MD

510-267-7540nicola.klein@kp.org

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Satoshi Kamidani

satoshi.kamidani@emory.edu

Columbia University

Recruiting

New York, New York, United States, 10027

Contacts

Melissa S Stockwell, MD

212-342-5732mss2112@cumc.columbia.edu

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Michael J Smith, MD

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

Emily A Randolph, MBA

919-385-5785emily.randolph@duke.edu

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Elizabeth Schlaudecker, MD

513-803-0747elizabeth.schlaudecker@ccmc.org

Mary Staat, MD

513-636-2877mary.staat@cchmc.org

More Information

Sponsor

Duke University

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Duke University on 2026-03-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.