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Can babies get RSV protection and routine shots at the same visit? new study aims to find out.

NCT ID NCT07158814

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether giving infants an RSV preventive antibody at the same time as their regular vaccines is safe. About 524 babies aged 6 weeks to under 30 weeks will take part. Researchers will compare fever rates in babies who get the RSV shot together with vaccines versus those who get them on separate days.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 524 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 30 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centers for Disease Control and Prevention

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30333, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Columbia University

    RECRUITING

    New York, New York, 10027, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Kaiser Permanente Northern California

    RECRUITING

    Oakland, California, 94612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.