Trials / Unknown
UnknownNCT04909021
Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 63 (estimated)
- Sponsor
- Meissa Vaccines, Inc. · Industry
- Sex
- All
- Age
- 6 Months – 36 Months
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Investigational RSV vaccine MV-012-968 (Dosage 1) | Single dose administered intranasally on Day 1 |
| BIOLOGICAL | Investigational RSV vaccine MV-012-968 (Dosage 2) | Single dose administered intranasally on Day 1 |
| BIOLOGICAL | Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose) | Single dose administered intranasally on Day 1 |
| BIOLOGICAL | Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose) | Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit |
| OTHER | Placebo (single-dose) | Single dose administered intranasally on Day 1 |
| OTHER | Placebo (two-dose) | Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit |
Timeline
- Start date
- 2021-06-03
- Primary completion
- 2023-10-01
- Completion
- 2023-10-01
- First posted
- 2021-06-01
- Last updated
- 2022-08-02
Locations
12 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04909021. Inclusion in this directory is not an endorsement.