Efficacy and Safety of Two Doses of HIL-214 in Children
- Conditions
- Gastroenteritis
- Interventions
- Biological: HIL-214Biological: Placebo
- Registration Number
- NCT05281094
- Lead Sponsor
- HilleVax
- Brief Summary
This is a randomized, placebo-controlled study that is being done to evaluate the safety and effectiveness of two doses of the HIL-214 vaccine compared to a placebo. The study will enroll 3000 children who will be 5 months of age at the time of the first dose study vaccine. The second dose of study vaccine will be given 28 days after the first dose.
- Detailed Description
Noroviruses have emerged as the single most significant cause of gastroenteritis in both middle-high income countries and low resource settings worldwide. Those most at risk of severe illness include the very young, the elderly and immunocompromised individuals. Noroviruses are highly infectious, highly resistant to environmental conditions, and have multiple routes of transmission including person-to-person, food-borne and contaminated surfaces. Noroviruses can cause acute, mild to severe illness characterized by vomiting, diarrhea, fever, dehydration and abdominal pain, representing a significant burden to public health. The clinical presentation in adults and older children is similar. While mortality due to acute gastroenteritis (AGE) caused by norovirus in the pediatric population is rare in industrialized countries, it is more common in developing countries. Although potentially a cause for hospitalization in very young children, there are fewer cases during the first 6 months of life possibly due to the protection offered by maternal antibodies from trans-placental transfer and in breast milk. In addition, norovirus infections have significant socioeconomic impact on hospitals, schools, day care centers and other closed settings. As the burden of rotavirus in children decreases due to successful rotavirus vaccination programs in infants, norovirus infections are increasingly recognized as the primary cause of AGE in many countries around the world.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 3085
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental HIL-214 One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57. Placebo Placebo One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57.
- Primary Outcome Measures
Name Time Method Primary Objective From 4 weeks after second vaccination through the end of the surveillance period The number of subjects with moderate to severe AGE cases associated with GI.1 or GII.4 NoV genotypes.
- Secondary Outcome Measures
Name Time Method Secondary Objective From 4 weeks after second vaccination through the end of the surveillance period The number of subjects with moderate to severe AGE associated only with ANY NoV genotypes
Trial Locations
- Locations (17)
DM Clinical Research
🇺🇸Houston, Texas, United States
Instituto de Investigacion Nutricional
🇵🇪Lima, Peru
CEVAXIN David
🇵🇦David, Chiriqui, Panama
Cntro de Estudios en Infectologia Pediatrica (CEIP)
🇨🇴Cali, Valle Del Cauca, Colombia
CEVAXIN 24 Decembre
🇵🇦Panama City, Panama
Policlinico Social del Norte
🇨🇴Bogotá, Distrito Capital, Colombia
Hospital General Regional Marcelino Velez Santana
🇩🇴Santo Domingo, Dominican Republic
CAIMED - Dominican Center for Clinical Studies
🇩🇴Santo Domingo, Dominican Republic
Fundacion Dominicana de Perinatologia Pro Bebe
🇩🇴Santo Domingo, Dominican Republic
Demedica
🇭🇳San Pedro Sula, Honduras
Clínica Cruz Jiminian
🇩🇴Santo Domingo, Dominican Republic
CEVAXIN La Chorrera
🇵🇦La Chorrera, Panama
INVERIME - Inversiones en Investigación Medica
🇭🇳Tegucigalpa, Honduras
Clinical Research Puerto Rico
🇵🇷Guayama, Puerto Rico
Investigación Sin Limite
🇭🇳Tegucigalpa, Honduras
CEVAXIN Av. México
🇵🇦Ciudad de Panamá, Panama
Hospital Pediátrico Dr. Hugo Mendoza
🇩🇴Santo Domingo, Distrito Nacional, Dominican Republic