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Safety of RSV Preventive Monoclonal Antibody

Testing safety of RSV antibody. Participation involves a clinical trial.

Recruiting
6-30 years
All
Phase 4
**Safety of RSV Preventive Monoclonal Antibody Study** This study looks at how safe it is to give a special medicine called RSV preventive monoclonal antibody along with other regular vaccines for babies. RSV stands for Respiratory Syncytial Virus, which can affect infants. Monoclonal antibodies are lab-made proteins that help fight infections. The study compares giving the RSV antibody and vaccines at the same time or at different visits. Parents will watch for fever and other side effects for 7 days after each visit. Serious side effects will be tracked throughout the study. Babies between 6 and 30 weeks old, who are eligible for the RSV antibody and other vaccines, can join. Parents must agree to participate and follow up with the study team. **Key Points:** - **Length of Study:** Parents need to track side effects for 7 days after each visit. - **Visits:** Babies may need to visit the clinic twice. - **Eligibility:** Babies need to be between 6 to 30 weeks old and able to get RSV antibodies. Parents should consider the time commitment and follow-up requirements when deciding to participate.
Study details
    Fever
    Adverse Event Following Immunisation

NCT07158814

Duke University

12 September 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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