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Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03507738
Collaborator
(none)
110
Enrollment
2
Locations
8
Arms
11.8
Actual Duration (Months)
55
Patients Per Site
4.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: MT-5625 low dose
  • Biological: MT-5625 middle dose
  • Biological: MT-5625 high dose
  • Biological: Rotarix
  • Biological: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jul 3, 2018
Actual Primary Completion Date :
Jun 28, 2019
Actual Study Completion Date :
Jun 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adult MT-5625 middle dose

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

Biological: MT-5625 middle dose
Intramuscular injection

Biological: Placebo
Intramuscular injection
Experimental: Adult MT-5625 high dose

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

Biological: MT-5625 high dose
Intramuscular injection

Biological: Placebo
Intramuscular injection
Experimental: Toddler MT-5625 middle dose

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

Biological: MT-5625 middle dose
Intramuscular injection

Biological: Placebo
Intramuscular injection
Experimental: Toddler MT-5625 high dose

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

Biological: MT-5625 high dose
Intramuscular injection

Biological: Placebo
Intramuscular injection
Experimental: Infant MT-5625 low dose

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

Biological: MT-5625 low dose
Intramuscular injection

Biological: Placebo
Intramuscular injection
Experimental: Infant MT-5625 middle dose

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

Biological: MT-5625 middle dose
Intramuscular injection

Biological: Placebo
Intramuscular injection
Experimental: Infant MT-5625 high dose

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

Biological: MT-5625 high dose
Intramuscular injection

Biological: Placebo
Intramuscular injection
Active Comparator: Rotarix

Infant receiving oral administration with Rotarix

Biological: Rotarix
Oral administration

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects with local reactions and reactogenicity events. [Within 7 days after each vaccination]

  2. Proportion of subjects reporting adverse events. [Within 28 days after each vaccination]

Secondary Outcome Measures

  1. Proportion of subjects with anti-MT-5625 IgG seroresponses [Day 28 after each vaccination]

  2. Proportion of subjects with neutralizing antibody responses [Day 28 after each vaccination]

  3. Anti-MT-5625 IgG geometric mean titers (GMTs) 28 days after each injection in adults, toddlers, and infants. [Day 28 after each vaccination]

  4. Neutralizing antibody GMTs against rotavirus 28 days after each injection in adults, toddlers and infants. [Day 28 after each vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Weeks to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigational center Adelaide Australia
2 Investigational center Johannesburg South Africa

Sponsors and Collaborators

  • Mitsubishi Tanabe Pharma Corporation

Investigators

  • Study Director: General Manager, Mitsubishi Tanabe Pharma Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT03507738
Other Study ID Numbers:
  • MT-5625-01
First Posted:
Apr 25, 2018
Last Update Posted:
Aug 6, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 6, 2019