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Tests treatment safety and results for Fever
Official title Safety of RSV Preventive Monoclonal Antibody
ClinicalTrials.gov ID: NCT07158814
What this study is testing
What is Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody?
Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody is an investigational medicine, being studied as a potential treatment for fever.
Also referred to as Nirsevimab, Beyfortus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 30. Healthy volunteers may be eligible.
You may be able to join 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...
- 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
You likely can't join 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...
- 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...
- Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 48 hours prior to enrollment (This may result in a temporary delay of...
See the full eligibility 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
- 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...
- 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)...
- 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...
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Oakland, California, United States
- Atlanta, Georgia, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 weeks to 30 weeks. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oakland, California, United States; Atlanta, Georgia, United States; New York, New York, United States; Durham, North Carolina, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.