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Safety of RSV Preventive Monoclonal Antibody

NCT07158814 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 524

Last updated 2026-03-16

No results posted yet for this study

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

Interventions

DRUG

Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody

ACIP Recommended Preventive Monoclonal Antibody

Sponsors & Collaborators

Principal Investigators

  • Michael J Smith, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-02
Primary Completion
2027-02-28
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07158814 on ClinicalTrials.gov