FeverPhase 4NCT07158814
Safety of RSV Preventive Monoclonal Antibody
A Phase 4 study testing Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody in people with Fever and Adverse Event Following Immunisation, run by Duke University at 6 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 6 to 30 weeksHealthy volunteers can take part
- Conditions the study is for
- Fever, Adverse Event Following Immunisation
- What is being tested?
- Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Oct 2025to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 30 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Satoshi Kamidani, satoshi.kamidani@emory.edu
- Active, not recruiting
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Elizabeth Schlaudecker, MD, 513-803-0747, elizabeth.schlaudecker@ccmc.org
Mary Staat, MD, 513-636-2877, mary.staat@cchmc.org
- Recruiting
Duke University
Durham, North Carolina, 27710
Michael J Smith, MD, 919-684-6335, michael.j.smith@duke.edu
Emily A Randolph, MBA, 919-385-5785, emily.randolph@duke.edu
- Recruiting
Columbia University
New York, New York, 10027
Melissa S Stockwell, MD, 212-342-5732, mss2112@cumc.columbia.edu
- Recruiting
Kaiser Permanente Northern California
Oakland, California, 94612
Nicola Klein, MD, 510-267-7540, nicola.klein@kp.org
About this study
Official title: Safety of Simultaneous Administration of Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody With Routine Childhood Immunizations in Infants
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).
Read the detailed description
Parent(s) or legal guardians will assess fever and other solicited local and systemic adverse events on the day of immunization (Day 1) and the next 6 days (through Day 7) following Visit 1 and Visit 2 using either a web-based data collection system or a paper memory aid. Serious adverse events and adverse events of special interest will be captured during the entire study period.
- Conditions
- Fever, Adverse Event Following Immunisation
- Being tested
- Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody
- Keywords
- Respiratory Syncytial Virus (RSV), Fever Following Immunization, RSV Monoclonal Antibody
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Syncytial Virus (RSV) Preventive Monoclonal AntibodyDrug
Also called Nirsevimab, Beyfortus
ACIP Recommended Preventive Monoclonal Antibody
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous Immunization | Experimental | The simultaneous immunization group will receive routine childhood vaccinations and respiratory syncytial virus (RSV) preventive monoclonal antibody at Visit 1. Receives: 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. Receives: Drug: Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 days post administration
Secondary outcomes (4)
Number of Participants with Grade 2 and/or 3 Fever Following Visit 1
Number of infants with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
Measured: Up to 2 days post administration
Number of Participants with Grade 2 and/or 3 Fever Following Visit 2
Number of infants with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)
Measured: Up to 2 days post administration
The Number of Participants with At Least One Serious Adverse Event
Measured: Up to 98 days post administration
The Number of Participants with At Least One Adverse Event of Special Interest
Measured: Up to 98 days post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start2 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Children's Hospital Medical Center, Cincinnati, Columbia University, Emory University, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Michael J Smith, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158814
- Sponsor's protocol ID
- Pro00117888
- Status last verified
- Mar 2026
- First submitted
- 4 Sep 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Simultaneous Administration of Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody With Routine Childhood Immunizations in Infants
- ClinicalTrials.gov ID
- NCT07158814
- Acronym / sponsor ID
- Pro00117888
- Conditions
- Fever, Adverse Event Following Immunisation
- Keywords
- Respiratory Syncytial Virus (RSV), Fever Following Immunization, RSV Monoclonal Antibody
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Children's Hospital Medical Center, Cincinnati, Columbia University, Emory University, Kaiser Permanente
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Parent(s) or legal guardians will assess fever and other solicited local and systemic adverse events on the day of immunization (Day 1) and the next 6 days (through Day 7) following Visit 1 and Visit 2 using either a web-based data collection system or a paper memory aid. Serious adverse events and adverse events of special interest will be captured during the entire study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous Immunization | Experimental | Drug: Respiratory Syncytial Virus (RSV) Preventive Monoclonal AntibodyThe simultaneous immunization group will receive routine childhood vaccinations and respiratory syncytial virus (RSV) preventive monoclonal antibody at Visit 1. |
| Sequential Immunization | Experimental | Drug: Respiratory Syncytial Virus (RSV) Preventive Monoclonal AntibodyThe sequential immunization group will receive routine childhood vaccinations at Visit 1, followed by respiratory syncytial virus (RSV) preventive monoclonal antibody at Visit 2. |
Who may qualify
- Ages
- 6 to 30 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Syncytial Virus (RSV) Preventive Monoclonal AntibodyAlso: Nirsevimab, BeyfortusACIP Recommended Preventive Monoclonal Antibody | Drug | Sequential Immunization, Simultaneous Immunization |
Primary outcome
Number of Participants with Fever Following Immunization
Time frame: Up to 2 days post administration
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.
4 secondary outcomes
Number of Participants with Grade 2 and/or 3 Fever Following Visit 1
Time frame: Up to 2 days post administration
Number of Participants with Grade 2 and/or 3 Fever Following Visit 2
Time frame: Up to 2 days post administration
The Number of Participants with At Least One Serious Adverse Event
Time frame: Up to 98 days post administration
The Number of Participants with At Least One Adverse Event of Special Interest
Time frame: Up to 98 days post administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael J Smith, MD principal investigator
Duke University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody in people with Fever and Adverse Event Following Immunisation, run by Duke University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael J Smith, MD (919 684 6335, michael.j.smith@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Fever Following Immunization (time frame: Up to 2 days post administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.