History of Changes for Study: NCT05281094

Efficacy and Safety of Two Doses of HIL-214 in Children

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Study Record Versions

Version	Submitted Date	Changes
1	March 10, 2022	None (earliest Version on record)
2	March 31, 2022	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	April 21, 2022	Study Status and Contacts/Locations
4	April 28, 2022	Contacts/Locations and Study Status
5	May 15, 2022	Contacts/Locations and Study Status
6	June 9, 2022	Contacts/Locations and Study Status
7	August 26, 2022	Contacts/Locations and Study Status
8	October 5, 2022	Contacts/Locations and Study Status
9	October 19, 2022	Contacts/Locations and Study Status
10	December 12, 2022	Study Status and Contacts/Locations
11	January 31, 2023	Study Status
12	February 23, 2023	Contacts/Locations and Study Status
13	April 5, 2023	Contacts/Locations and Study Status
14	May 2, 2023	Recruitment Status, Study Status, Contacts/Locations and Study Design
15	May 9, 2023	Outcome Measures and Study Status
16	May 23, 2023	Outcome Measures and Study Status
17	January 3, 2024	Study Status
18	March 6, 2024	Study Status
19	March 7, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	NOR-212
Brief Title:	Efficacy and Safety of Two Doses of HIL-214 in Children
Official Title:	A Phase 2b, Double-blind, Randomized, Multi-site, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Immunogenicity of Intramuscular HIL-214 Norovirus Vaccine in Healthy Children 5 Months of Age at Initial Vaccination
Secondary IDs:

Study Status


Record Verification:	March 2022
Overall Status:	Not yet recruiting
Study Start:	March 11, 2022
Primary Completion:	November 11, 2022 [Anticipated]
Study Completion:	June 11, 2024 [Anticipated]

First Submitted:	February 17, 2022
First Submitted that Met QC Criteria:	March 10, 2022
First Posted:	March 16, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	March 10, 2022
Last Update Posted:	March 16, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	HilleVax
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

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.

Conditions


Conditions:	Gastroenteritis
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Phase 2/Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	3000 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Placebo Comparator: Placebo One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57.	Biological: Placebo 2 injections - given on Day 1 and the second given between Day 29 - Day 57
Experimental: Experimental One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57.	Biological: HIL-214 2 injections - given on Day 1 and the second given between Day 29 - Day 57

Outcome Measures


Primary Outcome Measures:
1.	Primary Objective [ Time Frame: 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:
1.	Key Secondary Objective [ Time Frame: 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.
Other Outcome Measures:
1.	Immunogenicity Objectives [ Time Frame: Through 28 days post Dose 2 ] Titer results for HBGA blocking antibody test
2.	Immunogenicity Objectives - Secondary [ Time Frame: Through 28 days post Dose 2 ] Titer results for Pan-Ig antibody test
3.	Solicited Local AEs [ Time Frame: Up to 7 days after each dose ] The number of subjects with solicited local AEs
4.	Solicited Systemic AEs [ Time Frame: Up to 7 days after each dose ] The number of subjects with solicited systemic AEs
5.	Unsolicited Symptomatic AEs [ Time Frame: Up to 28 days after each dose ] The number of subjects with unsolicited symptoms AEs
6.	AEs Leading to Withdrawal [ Time Frame: Up to 28 days after each dose ] The number AEs that lead to vaccine dose withdrawal
7.	Adverse Events and Serious Adverse Events [ Time Frame: Day 1 through end of trial, up to 2 years ] The number of AEs and SAEs that lead to the subject's withdrawal from the trial

Eligibility


Minimum Age:	5 Months
Maximum Age:	5 Months
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria The subject should be 5 months of age (within plus or minus 14 days) male or female Children who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator The subject's LAR signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements Children whose LARs can and are willing to comply with trial procedures and are available for the duration of follow-up Exclusion Criteria Clinically significant abnormality in growth by height, weight, or head circumference (according to local guidelines) Gastrointestinal abnormalities or any chronic gastrointestinal disease, including any uncorrected congenital malformation of the gastrointestinal tract according to medical history and/or physical examination Known hypersensitivity or allergy to any of the investigational vaccine components (including excipients) Any clinically significant active infection (as assessed by the investigator) or temperature ≥38.0°C (>100.4°F), within 3 days of intended trial vaccination Any serious chronic or progressive disease according to the judgment of the investigator (e.g., cardiac, renal or hepatic disease) Individuals with history of, e.g., convulsions/febrile convulsions, or any illness, that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the subjects due to participation in the trial Known or suspected impairment/alteration of immune function Subjects with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time Subjects who received or are scheduled to receive any other vaccines within 14 days (for inactivated vaccines and oral polio vaccine) or 28 days (for other live vaccines) before or after any dose of trial vaccine Subjects participating in any clinical trial with another investigational product 30 days prior to first trial visit or intend to participate in another clinical trial at any time during the conduct of this trial Subjects known to be positive for or in evaluation for possible human immunodeficiency virus infection Subject's LAR or subject's first-degree relatives involved in the trial conduct

Contacts/Locations


Central Contact Person:	Clinical Lead Telephone: 617-203-7722 Email: clinical.trials@hillevax.com
Locations:	United States, Texas
	DM Clinical Research Houston, Texas, United States, 77065 Contact:Contact: 281-517-0550 Contact:Principal Investigator: Kashif Ali
	Colombia, Cundinamarca
	CAIMED - Chía Clinical Research Center Chia, Cundinamarca, Colombia, 250008 Contact:Contact: +57 18707070 Contact:Contact: +57 311 5389274 Contact:Principal Investigator: Derly Carolina Hernandez Moreno
	Colombia, Distrito Capital
	Policlínico Social del Norte Bogotá, Distrito Capital, Colombia Contact:Contact: Angélica María Amador Gutierrez +57 3153516023 Contact:Contact: William Andrés Castaño Echeverry +57 3153516023 Contact:Principal Investigator: Camilo Rodriguez Contact:Principal Investigator: Dario Agudelo
	Colombia, Valle Del Cauca
	Centro de Estudios en Infectología Pediátrica (CEIP) Cali, Valle Del Cauca, Colombia, 760042
	Dominican Republic
	CAIMED - Dominican Center for Clinical Studies Santo Domingo, Dominican Republic Contact:Contact: (809) 412 5001 Contact:Principal Investigator: Luis Martinez Contact:Principal Investigator: Patria Aracena
	Fundacion Dominicana de Perinatologia Pro Bebe Santo Domingo, Dominican Republic Contact:Contact: 809-686-7096 Contact:Principal Investigator: Luis Maria Rivera Mejia
	Dominican Republic, Distrito Nacional
	Hospital Pediátrico Dr. Hugo Mendoza Santo Domingo, Distrito Nacional, Dominican Republic Contact:Contact: 829-712-1824 Contact:Principal Investigator: Claribel Silfa
	Mexico, Nuevo Leon
	Hospital Nogalar San Nicolás De Los Garza, Nuevo Leon, Mexico, 66450 Contact:Contact: +52 (01) 83 76 66 61 Contact:Principal Investigator: Amalia Guadalupe Becerra Aquino, MD
	Panama
	CEVAXIN Panama Clinic Panama City, Panama, 00831 Contact:Contact: +5073984386 Contact:Principal Investigator: Xavier Saez-Llorens
	Peru
	Instituto de Investigacion Nutricional Lima, Peru, 15024 Contact:Contact: +51 01 349 6023 Contact:Principal Investigator: Claudio Lanata De Las Casas
	Peru, Lima
	Instituto de Investigacion Nutricional-Las Gardenias San Juan de Lurigancho, Lima, Peru, 15024 Contact:Contact: +51 01 349 6023 Contact:Principal Investigator: Claudio Lanata De Las Casas

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