Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months
Public ClinicalTrials.gov record NCT04909021. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Phase 1c Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus Vaccine (MV-012-968) in Seronegative Children 6-36 Months
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study evaluates an investigational vaccine that is designed to protect humans against infection with respiratory syncytial virus (RSV) and is administered as a nasal spray. Specifically, the study analyzes the safety of, and the immune response to, the vaccine when administered to healthy children between the ages of 6 and 24 months who are seronegative to RSV.
Study identification
- NCT ID
- NCT04909021
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Interventions
- Investigational RSV vaccine MV-012-968 (Dosage 1) Biological
- Investigational RSV vaccine MV-012-968 (Dosage 2) Biological
- Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose) Biological
- Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose) Biological
- Placebo (single-dose) Other
- Placebo (two-dose) Other
Biological · Other
Eligibility (public fields only)
- Age range
- 6 Months to 36 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2, 2021
- Primary completion
- Sep 30, 2023
- Completion
- Sep 30, 2023
- Last update posted
- Aug 1, 2022
2021 – 2023
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| MedPharmics | Phoenix | Arizona | 85015 | Recruiting |
| Paradigm Clinical Research | La Mesa | California | 91942 | Not yet recruiting |
| The Emory Children's Center | Atlanta | Georgia | 30322 | Recruiting |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | Not yet recruiting |
| MedPharmics | Metairie | Louisiana | 70006 | Recruiting |
| Meridian Clinical Research | Hastings | Nebraska | 68901 | Not yet recruiting |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | Recruiting |
| Meridian Clinical Research | Binghamton | New York | 41348 | Recruiting |
| Aventiv Research | Columbus | Ohio | 43213 | Not yet recruiting |
| Coastal Pediatric Research | Summerville | South Carolina | 29486 | Not yet recruiting |
| PanAmerican Clinical Research | Brownsville | Texas | 78520 | Not yet recruiting |
| Benchmark Research | San Antonio | Texas | 78240 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04909021, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 1, 2022 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04909021 live on ClinicalTrials.gov.