- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03507738
Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants
August 4, 2019 updated by: Mitsubishi Tanabe Pharma Corporation
A Phase 1, Randomized, Placebo-controlled, Descending Age, Dose-escalation Study to Assess the Safety and Immunogenicity of an Investigational Non-Replicating Rotavirus Vaccine (MT-5625) in Healthy Adults, Toddlers and Infants
A study to investigate the safety and reactogenicity of MT-5625 independently in adults aged 18-35 years, toddlers ages 12-24 months, and infants aged 6-10 weeks
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Adelaide, Australia
- Investigational center
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-
-
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Johannesburg, South Africa
- Investigational center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 35 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female adults/toddlers/infants as established by medical history and clinical examination before entering the study
- 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:
ALL SUBJECTS
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adult MT-5625 middle dose
Adult receiving intramuscular injection with either middle dose of MT-5625 or placebo
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Intramuscular injection
Intramuscular injection
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Experimental: Adult MT-5625 high dose
Adult receiving intramuscular injection with either high dose of MT-5625 or placebo
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Intramuscular injection
Intramuscular injection
|
Experimental: Toddler MT-5625 middle dose
Toddler receiving intramuscular injection with either middle dose of MT-5625 or placebo
|
Intramuscular injection
Intramuscular injection
|
Experimental: Toddler MT-5625 high dose
Toddler receiving intramuscular injection with either high dose of MT-5625 or placebo
|
Intramuscular injection
Intramuscular injection
|
Experimental: Infant MT-5625 low dose
Infant receiving intramuscular injection with either low dose of MT-5625 or placebo
|
Intramuscular injection
Intramuscular injection
|
Experimental: Infant MT-5625 middle dose
Infant receiving intramuscular injection with either middle dose of MT-5625 or placebo
|
Intramuscular injection
Intramuscular injection
|
Experimental: Infant MT-5625 high dose
Infant receiving intramuscular injection with either high dose of MT-5625 or placebo
|
Intramuscular injection
Intramuscular injection
|
Active Comparator: Rotarix
Infant receiving oral administration with Rotarix
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Oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects with local reactions and reactogenicity events.
Time Frame: Within 7 days after each vaccination
|
Within 7 days after each vaccination
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Proportion of subjects reporting adverse events.
Time Frame: Within 28 days after each vaccination
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Within 28 days after each vaccination
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects with anti-MT-5625 IgG seroresponses
Time Frame: Day 28 after each vaccination
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Day 28 after each vaccination
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Proportion of subjects with neutralizing antibody responses
Time Frame: Day 28 after each vaccination
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Day 28 after each vaccination
|
Anti-MT-5625 IgG geometric mean titers (GMTs) 28 days after each injection in adults, toddlers, and infants.
Time Frame: Day 28 after each vaccination
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Day 28 after each vaccination
|
Neutralizing antibody GMTs against rotavirus 28 days after each injection in adults, toddlers and infants.
Time Frame: Day 28 after each vaccination
|
Day 28 after each vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2018
Primary Completion (Actual)
June 28, 2019
Study Completion (Actual)
June 28, 2019
Study Registration Dates
First Submitted
April 15, 2018
First Submitted That Met QC Criteria
April 15, 2018
First Posted (Actual)
April 25, 2018
Study Record Updates
Last Update Posted (Actual)
August 6, 2019
Last Update Submitted That Met QC Criteria
August 4, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- MT-5625-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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