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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03507738




Registration number
NCT03507738
Ethics application status
Date submitted
15/04/2018
Date registered
25/04/2018
Date last updated
6/08/2019

Titles & IDs
Public title
Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants
Scientific title
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
Secondary ID [1] 0 0
MT-5625-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MT-5625 low dose
Treatment: Other - MT-5625 middle dose
Treatment: Other - MT-5625 high dose
Treatment: Other - Rotarix
Treatment: Other - Placebo

Experimental: Adult MT-5625 middle dose - Adult receiving intramuscular injection with either middle dose of MT-5625 or placebo

Experimental: Adult MT-5625 high dose - Adult receiving intramuscular injection with either high dose of MT-5625 or placebo

Experimental: Toddler MT-5625 middle dose - Toddler receiving intramuscular injection with either middle dose of MT-5625 or placebo

Experimental: Toddler MT-5625 high dose - Toddler receiving intramuscular injection with either high dose of MT-5625 or placebo

Experimental: Infant MT-5625 low dose - Infant receiving intramuscular injection with either low dose of MT-5625 or placebo

Experimental: Infant MT-5625 middle dose - Infant receiving intramuscular injection with either middle dose of MT-5625 or placebo

Experimental: Infant MT-5625 high dose - Infant receiving intramuscular injection with either high dose of MT-5625 or placebo

Active comparator: Rotarix - Infant receiving oral administration with Rotarix


Treatment: Other: MT-5625 low dose
Intramuscular injection

Treatment: Other: MT-5625 middle dose
Intramuscular injection

Treatment: Other: MT-5625 high dose
Intramuscular injection

Treatment: Other: Rotarix
Oral administration

Treatment: Other: Placebo
Intramuscular injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with local reactions and reactogenicity events.
Timepoint [1] 0 0
Within 7 days after each vaccination
Primary outcome [2] 0 0
Proportion of subjects reporting adverse events.
Timepoint [2] 0 0
Within 28 days after each vaccination
Secondary outcome [1] 0 0
Proportion of subjects with anti-MT-5625 IgG seroresponses
Timepoint [1] 0 0
Day 28 after each vaccination
Secondary outcome [2] 0 0
Proportion of subjects with neutralizing antibody responses
Timepoint [2] 0 0
Day 28 after each vaccination
Secondary outcome [3] 0 0
Anti-MT-5625 IgG geometric mean titers (GMTs) 28 days after each injection in adults, toddlers, and infants.
Timepoint [3] 0 0
Day 28 after each vaccination
Secondary outcome [4] 0 0
Neutralizing antibody GMTs against rotavirus 28 days after each injection in adults, toddlers and infants.
Timepoint [4] 0 0
Day 28 after each vaccination

Eligibility
Key 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
Minimum age
6 Weeks
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2019
Sample size
Target
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational center - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
South Africa
State/province [1] 0 0
Johannesburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mitsubishi Tanabe Pharma Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/study/NCT03507738
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
General Manager
Address 0 0
Mitsubishi Tanabe Pharma Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03507738