Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants
NCT ID: NCT03507738
Last Updated: 2019-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
110 participants
INTERVENTIONAL
2018-07-03
2019-06-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Adult MT-5625 middle dose
Adult receiving intramuscular injection with either middle dose of MT-5625 or placebo
MT-5625 middle dose
Intramuscular injection
Placebo
Intramuscular injection
Adult MT-5625 high dose
Adult receiving intramuscular injection with either high dose of MT-5625 or placebo
MT-5625 high dose
Intramuscular injection
Placebo
Intramuscular injection
Toddler MT-5625 middle dose
Toddler receiving intramuscular injection with either middle dose of MT-5625 or placebo
MT-5625 middle dose
Intramuscular injection
Placebo
Intramuscular injection
Toddler MT-5625 high dose
Toddler receiving intramuscular injection with either high dose of MT-5625 or placebo
MT-5625 high dose
Intramuscular injection
Placebo
Intramuscular injection
Infant MT-5625 low dose
Infant receiving intramuscular injection with either low dose of MT-5625 or placebo
MT-5625 low dose
Intramuscular injection
Placebo
Intramuscular injection
Infant MT-5625 middle dose
Infant receiving intramuscular injection with either middle dose of MT-5625 or placebo
MT-5625 middle dose
Intramuscular injection
Placebo
Intramuscular injection
Infant MT-5625 high dose
Infant receiving intramuscular injection with either high dose of MT-5625 or placebo
MT-5625 high dose
Intramuscular injection
Placebo
Intramuscular injection
Rotarix
Infant receiving oral administration with Rotarix
Rotarix
Oral administration
Interventions
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MT-5625 low dose
Intramuscular injection
MT-5625 middle dose
Intramuscular injection
MT-5625 high dose
Intramuscular injection
Rotarix
Oral administration
Placebo
Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Adults aged \>18 and \< 35, toddlers aged \>12 and \< 24 months, and infants aged \> 6 and \< 10 weeks at the time of enrollment
* Subject (or Parent/Legal Guardian) willing and able to give written informed consent after the nature of the study has been explained
* Subject (or Parent/Legal Guardian) willing to comply with the study restrictions and study schedule and to remain in the area for the study duration
* Females of potential childbearing must not be pregnant or breastfeeding and willing to use adequate method of contraception during the trial
Exclusion Criteria
* Presence of fever or other acute illness
* Concurrent participation in another clinical trial or receipt of an investigational product during the 30 days prior to randomization
* Suspected or known impairment of immune function
* Known sensitivity to any components of the study vaccine
* History of anaphylactic reaction
* Receipt of immunoglobulin therapy or blood products in last 6 months
* History of chronic immunosuppressive medications (with the exception of inhaled or topical steroids)
* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
ADULTS ONLY
* Have received any vaccine within 4 weeks prior to randomization
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product (IP)
* Any clinically significant abnormalities on 12-lead ECG as judged by the Investigator
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody
* Have any contraindications to parenteral injections ( eg history of bleeding disorder)
* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the Investigator
* Donated blood within the 4 weeks prior to randomization
TODDLERS and INFANTS
* Received any vaccine within 14 days of randomization
* Presence of malnutrition or other systemic disorders
* History of congenital abdominal disorders, intussusception or abdominal surgery
* Major congenital or genetic defect
TODDLERS ONLY
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
INFANTS ONLY
* Infants with history of premature birth (\<37 weeks gestational age)
* Infants who have received rotavirus vaccine in the past
* Known sensitivity to any components of the study vaccine, including Rotarix®
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis B core antibody, and hepatitis C antibody
* HIV infection assessed by PCR if mother is not known to be negative (negative test result between 24 weeks gestation and screening).
6 Weeks
35 Years
ALL
Yes
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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General Manager
Role: STUDY_DIRECTOR
Mitsubishi Tanabe Pharma Corporation
Locations
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Investigational center
Adelaide, , Australia
Investigational center
Johannesburg, , South Africa
Countries
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References
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Kurokawa N, Robinson MK, Bernard C, Kawaguchi Y, Koujin Y, Koen A, Madhi S, Polasek TM, McNeal M, Dargis M, Couture MM, Trepanier S, Forrest BD, Tsutsui N. Safety and immunogenicity of a plant-derived rotavirus-like particle vaccine in adults, toddlers and infants. Vaccine. 2021 Sep 15;39(39):5513-5523. doi: 10.1016/j.vaccine.2021.08.052. Epub 2021 Aug 25.
Other Identifiers
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MT-5625-01
Identifier Type: -
Identifier Source: org_study_id
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