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NCT06546423 · ClinicalTrials.gov registry record · Phase 1
Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, B/HPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to <60 Months of Age
A Phase 1 study of Human Metapneumovirus and Human Parainfluenza Virus Type 3, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 4
- Study locations
NCT06546423: Recruiting Phase 1 study of Human Metapneumovirus and Human Parainfluenza Virus Type 3, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06546423 is a Phase 1 study of Human Metapneumovirus and Human Parainfluenza Virus Type 3 that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06546423, a Phase 1 study of Human Metapneumovirus and Human Parainfluenza Virus Type 3, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 4
- Study locations
Study Summary
HPIV3 and HMPV are viruses that can cause breathing problems in children. The goal of this clinical trial is to look at the safety of 2 experimental HPIV3/HMPV vaccines in HPIV3-seropositive children ≥ 24 months to \< 60 months of age. Children will receive B/HPIV3/HMPV-PreF-A vaccine, B/HPIV3/HMPV-F-B365 vaccine, or placebo, and participants will not know which study product they have received. The main goals of the study are to find out whether these vaccines are well-tolerated and infectious in HPIV3-seropositive children. The general procedures include daily temperature measurements and daily contact with the participant for the first 28 days, giving a single dose of one of the 2 study vaccines or placebo delivered by nasal sprayer, about 9 in-person visits, a physical examination, 7 clinical assessments, 2 blood samples, 9 nasal swabs and monthly contacts with the participant between Days 29-180. Additional visits may occur if the child has a respiratory illness, fever, or ear infections. The illness visit will include a nasal swab and a clinical assessment.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL B/HPIV3/HMPV-PreF-A vaccine
- BIOLOGICAL B/HPIV3/HMPV-F-B365 vaccine
Study Locations (4)
Maryland
- CIR - Rangos, Johns Hopkins Bloomberg School of Public Health - Baltimore
- CIR South - Columbia
New York
- University of Rochester Medical Center - Rochester
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-07-12 |
| Est. Completion | 2025-06 |
| Phase | Phase 1 |
What NCT06546423 shows while recruiting
NCT06546423 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 2 conditions, with Human Metapneumovirus appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06546423 reports a single indexed study location in Maryland, New York, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06546423 about?
NCT06546423 is a clinical study titled "Study of the Infectivity, Safety and Immunogenicity of Two Recombinant, Live-Attenuated, B/HPIV3 Vectored Vaccines Expressing the Fusion Glycoprotein of HMPV Delivered by Nasal Spray to HPIV3-Seropositive Children 24 to <60 Months of Age". HPIV3 and HMPV are viruses that can cause breathing problems in children. The goal of this clinical trial is to look at the safety of 2 experimental HPIV3/HMPV vaccines in HPIV3-seropositive children ≥ 24 months to \< 60 months of age. Children will receive B/HPIV3/HMPV-PreF-A vaccine, B/HPIV3/HMPV-...
What is the current status of trial NCT06546423?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2024-07-12. Estimated completion is 2025-06.
What conditions does trial NCT06546423 study?
This clinical trial studies the following conditions: Human Metapneumovirus, Human Parainfluenza Virus Type 3.
What interventions are being tested in trial NCT06546423?
The interventions under investigation include: Placebo (DRUG), B/HPIV3/HMPV-PreF-A vaccine (BIOLOGICAL), B/HPIV3/HMPV-F-B365 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06546423?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06546423 being conducted?
This trial has 4 study locations across Maryland, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06546423's enrollment target sits among peer trials
25 1496th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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