Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants

Phase 1

Active, not recruiting

Brief Summary: This is a phase 1, randomized, double-blind multi-center, placebo-controlled trial in Japan to evaluate the safety and immunogenicity of HIL-214 in healthy infants 5 months of age (-14/+14 days) at first trial vaccine administration. In this protocol, because the trial is blinded, trial vaccine refers to both the investigational vaccine (HIL-214) and placebo.

Detailed Description: The rationale for trial NOR-109 is to evaluate the safety and immunogenicity of HIL-214 in Japanese pediatric subjects and establish whether the data obtained is consistent with that previously obtained for non-Japanese pediatric subjects.

The clinical trials for HIL-214 have so far been performed in Europe, the United States and several countries in Latin America \[26\]. The incidence rate of norovirus-attributable disease in Japan is at least as high as in other developed countries with the highest rates occurring in children below the age of 5 years and hospitalization most common in very young and very old populations. The inclusion of infants (5 months \[±14 days\] of age at the time of first trial vaccine administration) serves to compare the data obtained for infants of non-Japanese descent with Japanese infants, in alignment with the global clinical program, and to support the inclusion of Japanese infants into phase 3. Enrollment and vaccination of the infants will be performed either before or after the required routine childhood vaccines per the national immunization schedule.

This phase 1 trial in Japan aims to assess the safety and immunogenicity of two doses of HIL-214 administered 4 to 8 weeks apart, in 21 healthy infants aged 5 months at the time of the first trial vaccine dose administration. A placebo arm is included to allow an unbiased assessment of safety and immunogenicity.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One dose of placebo on Day 1 and one dose of placebo between Day 29 and Day 57
Experimental	HIL-214	One dose of HIL-214 on Day 1 and one dose of HIL-214 between Day 29 and Day 57

Primary Outcome Measures

Name	Time	Method
Primary Objective	3 months	All of the subjects in this trial will be assessed for safety of HIL-214 by comparing the occurrence and intensity of solicited and unsolicited local and systemic reactions to the study vaccine compared with placebo vaccination and including AEs leading to withdrawal of trial vaccine.
Number of subjects with solicited local AEs	up to 7 days post-dose 1 and dose 2.	Subjects that present with solicited systemic AEs.
Number of subjects with solicited Systemic AEs	up to 7 days post-dose 1 and dose 2.	Subjects that present with solicited systemic AEs.
Number of subjects with AEs leading to withdrawal	Up to 56 days post-dose 1	The number of AEs that lead to vaccine dose withdrawal.
Number of subjects with unsolicited symptomatic AEs	up to 28 days post-dose 1 and dose 2.	Subjects that present with unsolicited symptoms (AEs)
Number of subjects with Adverse Events and Serious Adverse Events	Through study completion, an average of 1 year.	The number of AEs and SAEs that lead to the subject's withdrawal from the trial

Secondary Outcome Measures

Name	Time	Method

Locations (4): Ohigesenseino Kodomo Clinic
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Sapporo-Shi, Japan
Fukui Aiiku Hospital
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Fukui-Shi, Japan
Iizuka Children's Clinic
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Iizuka-Shi, Japan
Childrens Clinic of Kose
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Kofu-Shi, Japan