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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
      • Adelaide, Australia
        • Investigational center
  • South Africa
      • Johannesburg, South Africa
        • Investigational center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adult MT-5625 middle dose
Adult receiving intramuscular injection with either middle dose of MT-5625 or placebo
Biological: Placebo
Intramuscular injection
Biological: MT-5625 middle dose
Intramuscular injection
Experimental: Adult MT-5625 high dose
Adult receiving intramuscular injection with either high dose of MT-5625 or placebo
Biological: Placebo
Intramuscular injection
Biological: MT-5625 high dose
Intramuscular injection
Experimental: Toddler MT-5625 middle dose
Toddler receiving intramuscular injection with either middle dose of MT-5625 or placebo
Biological: Placebo
Intramuscular injection
Biological: MT-5625 middle dose
Intramuscular injection
Experimental: Toddler MT-5625 high dose
Toddler receiving intramuscular injection with either high dose of MT-5625 or placebo
Biological: Placebo
Intramuscular injection
Biological: MT-5625 high dose
Intramuscular injection
Experimental: Infant MT-5625 low dose
Infant receiving intramuscular injection with either low dose of MT-5625 or placebo
Biological: Placebo
Intramuscular injection
Biological: MT-5625 low dose
Intramuscular injection
Experimental: Infant MT-5625 middle dose
Infant receiving intramuscular injection with either middle dose of MT-5625 or placebo
Biological: Placebo
Intramuscular injection
Biological: MT-5625 middle dose
Intramuscular injection
Experimental: Infant MT-5625 high dose
Infant receiving intramuscular injection with either high dose of MT-5625 or placebo
Biological: Placebo
Intramuscular injection
Biological: MT-5625 high dose
Intramuscular injection
Active Comparator: Rotarix
Infant receiving oral administration with Rotarix
Biological: Rotarix
Oral administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Proportion of subjects reporting adverse events.
Time Frame: Within 28 days after each vaccination
Within 28 days after each vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects with anti-MT-5625 IgG seroresponses
Time Frame: Day 28 after each vaccination
Day 28 after each vaccination
Proportion of subjects with neutralizing antibody responses
Time Frame: Day 28 after each vaccination
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
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mitsubishi Tanabe Pharma Corporation

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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