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Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children
NCT04919109 · View on ClinicalTrials.gov ↗
Study Summary
This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax-RSV in healthy children. They will be vaccinated in spring to early autumn 2023 and followed through the 2023-24 RSV season. 18 children aged 2 to 5 years who are RSV-seropositive (have antibodies to RSV) and 33 children aged 6 months to \< 2 years who are RSV-seronegative (do not have antibodies to RSV) will be enrolled in escalating-dose cohorts. A safety committee will review the safety profile of each dosing group before the next dose-escalation. Children will receive 2 doses of the vaccine at one of several dose levels or placebo (saline solution with no active ingredient) as nose drops; doses will be 28 days apart. A parent/guardian will record temperature and other conditions in a diary daily for 7 days after each dose. The parent/guardian will be contacted by telephone on the day after Dose 1 for safety assessment and review of the diary data. Children will return to the clinic 3, 7, 14, and 28 days after each dose. The parent/guardian will then be contacted by telephone monthly until 1 year after the second dose. Study procedures include physical examinations, vital signs, and collections of blood and nose/throat swab samples to look at safety of the vaccine and to analyze body's immune response.
Conditions Studied
Interventions
- BIOLOGICAL Normal Saline
- BIOLOGICAL CodaVax-RSV
Study Locations (5)
Nebraska
- Velocity — Lincoln
- Velocity — Omaha
Rhode Island
- Velocity — Providence
Utah
- Velocity — West Jordan
Other
- University of Witwatersrand (WITS)/Vaccines and Infectious Diseases Analytics (VIDA) — Johannesburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2023-03-28 |
| Est. Completion | 2025-08-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04919109
The ClinicalTrials.gov registry entry for NCT04919109 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Codagenix, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 2 interventions — of which Normal Saline is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04919109 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Nebraska, Rhode Island, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04919109 about?
NCT04919109 is a clinical study titled "Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children". This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax-RSV in healthy children. They will be vaccinated in spring to early autumn 2023 and followed through the 2023-24 RSV season. 18 children aged...
What is the current status of trial NCT04919109?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2023-03-28. Estimated completion is 2025-08-27.
What conditions does trial NCT04919109 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04919109?
The interventions under investigation include: Normal Saline (BIOLOGICAL), CodaVax-RSV (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04919109?
This trial is sponsored by Codagenix, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04919109 being conducted?
This trial has 5 study locations across Nebraska, Rhode Island, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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