Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months

PHASE1UnknownINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

June 3, 2021

Primary Completion Date

October 31, 2023

Study Completion Date

October 31, 2023

Conditions
Respiratory Syncytial Virus (RSV)
Interventions
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

Trial Locations (12)

29486

NOT_YET_RECRUITING

Coastal Pediatric Research, Summerville

30322

RECRUITING

The Emory Children's Center, Atlanta

41348

RECRUITING

Meridian Clinical Research, Binghamton

43213

NOT_YET_RECRUITING

Aventiv Research, Columbus

68134

RECRUITING

Meridian Clinical Research, Omaha

68901

NOT_YET_RECRUITING

Meridian Clinical Research, Hastings

70006

RECRUITING

MedPharmics, Metairie

78240

RECRUITING

Benchmark Research, San Antonio

78520

NOT_YET_RECRUITING

PanAmerican Clinical Research, Brownsville

83404

NOT_YET_RECRUITING

Clinical Research Prime, Idaho Falls

85015

RECRUITING

MedPharmics, Phoenix

91942

NOT_YET_RECRUITING

Paradigm Clinical Research, La Mesa

Sponsors
All Listed Sponsors
lead

Meissa Vaccines, Inc.

INDUSTRY

NCT04909021 - Safety and Immunogenicity of an Intranasal Vaccine for Respiratory Syncytial Virus in Seronegative Children 6-36 Months | Biotech Hunter | Biotech Hunter