HealthyPhase 1NCT03507738
Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants
A Phase 1 study testing MT-5625 low dose, MT-5625 middle dose and MT-5625 high dose in people with Healthy, run by Tanabe Pharma Corporation at 2 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 weeks to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MT-5625 low dose, MT-5625 middle dose and MT-5625 high dose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Jul 2018to 28 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official 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
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
- Conditions
- Healthy
- Being tested
- MT-5625 low dose, MT-5625 middle dose, MT-5625 high dose, Rotarix, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-5625 low doseBiological
Intramuscular injection
MT-5625 middle doseBiological
Intramuscular injection
MT-5625 high doseBiological
Intramuscular injection
RotarixBiological
Oral administration
PlaceboBiological
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Adult MT-5625 middle dose | Experimental | Adult receiving intramuscular injection with either middle dose of MT-5625 or placebo Receives: Biological: MT-5625 middle dose; Biological: Placebo |
| Adult MT-5625 high dose | Experimental | Adult receiving intramuscular injection with either high dose of MT-5625 or placebo Receives: Biological: MT-5625 high dose; Biological: Placebo |
| Toddler MT-5625 middle dose | Experimental | Toddler receiving intramuscular injection with either middle dose of MT-5625 or placebo Receives: Biological: MT-5625 middle dose; Biological: Placebo |
| Toddler MT-5625 high dose | Experimental | Toddler receiving intramuscular injection with either high dose of MT-5625 or placebo Receives: Biological: MT-5625 high dose; Biological: Placebo |
| Infant MT-5625 low dose | Experimental | Infant receiving intramuscular injection with either low dose of MT-5625 or placebo Receives: Biological: MT-5625 low dose; Biological: Placebo |
| Infant MT-5625 middle dose | Experimental | Infant receiving intramuscular injection with either middle dose of MT-5625 or placebo Receives: Biological: MT-5625 middle dose; Biological: Placebo |
| Infant MT-5625 high dose | Experimental | Infant receiving intramuscular injection with either high dose of MT-5625 or placebo Receives: Biological: MT-5625 high dose; Biological: Placebo |
| Rotarix | Active comparator | Infant receiving oral administration with Rotarix Receives: Biological: Rotarix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with local reactions and reactogenicity events.
Measured: Within 7 days after each vaccination
Proportion of subjects reporting adverse events.
Measured: Within 28 days after each vaccination
Secondary outcomes (4)
Proportion of subjects with anti-MT-5625 IgG seroresponses
Measured: Day 28 after each vaccination
Proportion of subjects with neutralizing antibody responses
Measured: Day 28 after each vaccination
Anti-MT-5625 IgG geometric mean titers (GMTs) 28 days after each injection in adults, toddlers, and infants.
Measured: Day 28 after each vaccination
Neutralizing antibody GMTs against rotavirus 28 days after each injection in adults, toddlers and infants.
Measured: Day 28 after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start3 Jul 2018
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507738
- Sponsor's protocol ID
- MT-5625-01
- Status last verified
- Aug 2019
- First submitted
- 15 Apr 2018
- Last updated
- 6 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34454786
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03507738
- Acronym / sponsor ID
- MT-5625-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Adult MT-5625 middle dose | Experimental | Biological: MT-5625 middle dose, Biological: PlaceboAdult receiving intramuscular injection with either middle dose of MT-5625 or placebo |
| Adult MT-5625 high dose | Experimental | Biological: MT-5625 high dose, Biological: PlaceboAdult receiving intramuscular injection with either high dose of MT-5625 or placebo |
| Toddler MT-5625 middle dose | Experimental | Biological: MT-5625 middle dose, Biological: PlaceboToddler receiving intramuscular injection with either middle dose of MT-5625 or placebo |
| Toddler MT-5625 high dose | Experimental | Biological: MT-5625 high dose, Biological: PlaceboToddler receiving intramuscular injection with either high dose of MT-5625 or placebo |
| Infant MT-5625 low dose | Experimental | Biological: MT-5625 low dose, Biological: PlaceboInfant receiving intramuscular injection with either low dose of MT-5625 or placebo |
| Infant MT-5625 middle dose | Experimental | Biological: MT-5625 middle dose, Biological: PlaceboInfant receiving intramuscular injection with either middle dose of MT-5625 or placebo |
| Infant MT-5625 high dose | Experimental | Biological: MT-5625 high dose, Biological: PlaceboInfant receiving intramuscular injection with either high dose of MT-5625 or placebo |
| Rotarix | Active comparator | Biological: RotarixInfant receiving oral administration with Rotarix |
Who may qualify
- Ages
- 6 weeks to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-5625 low doseIntramuscular injection | Biological | Infant MT-5625 low dose |
| MT-5625 middle doseIntramuscular injection | Biological | Adult MT-5625 middle dose, Infant MT-5625 middle dose, Toddler MT-5625 middle dose |
| MT-5625 high doseIntramuscular injection | Biological | Adult MT-5625 high dose, Infant MT-5625 high dose, Toddler MT-5625 high dose |
| RotarixOral administration | Biological | Rotarix |
| PlaceboIntramuscular injection | Biological | Adult MT-5625 high dose, Adult MT-5625 middle dose, Infant MT-5625 high dose, Infant MT-5625 low dose, Infant MT-5625 middle dose, Toddler MT-5625 high dose, Toddler MT-5625 middle dose |
Primary outcome
Proportion of subjects with local reactions and reactogenicity events.
Time frame: Within 7 days after each vaccination
Proportion of subjects reporting adverse events.
Time frame: Within 28 days after each vaccination
4 secondary outcomes
Proportion of subjects with anti-MT-5625 IgG seroresponses
Time frame: Day 28 after each vaccination
Proportion of subjects with neutralizing antibody responses
Time frame: 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
Neutralizing antibody GMTs against rotavirus 28 days after each injection in adults, toddlers and infants.
Time frame: Day 28 after each vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Derived from this study: PubMed 34454786Kurokawa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General Manager study director
Tanabe Pharma Corporation
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-5625 low dose, MT-5625 middle dose and MT-5625 high dose in people with Healthy, run by Tanabe Pharma Corporation at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with local reactions and reactogenicity events. (time frame: Within 7 days after each vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03507738, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2019.