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Safety and Immunogenicity of a New Formulation of Euvichol®

NCT02502331 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2015-12-17

No results posted yet for this study

Summary

* Number of doses and intervals: Two doses, 2 weeks apart
* Method of administration: Oral administration
* Volume of vaccine to be administered: 1.5 mL/dose
* Observational period: 4 weeks (2 weeks after each dose)
* Number of visits: 3 visits

1. Visit 1: Screening and enrollment (1st dosing)
2. Visit 2: 2nd dosing 2 weeks after 1st dose (14+3 days)
3. Visit 3: 2 weeks after the 2nd dose (28+3 days), end of subject participation. This study will be carried out in healthy adults and children, at two sites, enrollment will be competitive between the sites. Subjects will be stratified according to age into adults (18\~40 years of age) and children (1\~17 years of age). According to the pre-generated randomization list, the participants will be randomized to the test or comparator groups (Visit 1) and will be given either the test vaccine or the comparator vaccine. For immunogenicity assessment, blood sample will be taken at Visit 1 (prior to vaccination), Visit 2 (prior to vaccination), and at the end-of-study Visit (Visit 3). For Safety assessment: the participants will be observed for 30 minutes post vaccination and instructed to record solicited adverse events that occur up to 6 days after vaccination on the participant diary card.

This study is observer-blind: vaccine administrator and vaccine safety evaluator will be two distinct persons to avoid bias of safety assessment. Trial staff other than the vaccine administrator will remain blinded and will not handle the investigational product.

Conditions

  • Cholera

Interventions

BIOLOGICAL

Test Oral Cholera Vaccine

Thimerosal free, manufactured at 600 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd.

BIOLOGICAL

Euvichol®

Licensed, manufactured at 100 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd.

Sponsors & Collaborators

  • EuBiologics Co.,Ltd

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Laura Digilio, MD · International Vaccince Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-06-30
Completion
2016-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02502331 on ClinicalTrials.gov