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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 110

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant MT-5625 middle dose	Placebo	Infant receiving intramuscular injection with either middle dose of MT-5625 or placebo
Toddler MT-5625 high dose	Placebo	Toddler receiving intramuscular injection with either high dose of MT-5625 or placebo
Adult MT-5625 high dose	Placebo	Adult receiving intramuscular injection with either high dose of MT-5625 or placebo
Toddler MT-5625 middle dose	MT-5625 middle dose	Toddler receiving intramuscular injection with either middle dose of MT-5625 or placebo
Infant MT-5625 low dose	MT-5625 low dose	Infant receiving intramuscular injection with either low dose of MT-5625 or placebo
Adult MT-5625 middle dose	MT-5625 middle dose	Adult receiving intramuscular injection with either middle dose of MT-5625 or placebo
Adult MT-5625 middle dose	Placebo	Adult receiving intramuscular injection with either middle dose of MT-5625 or placebo
Toddler MT-5625 middle dose	Placebo	Toddler receiving intramuscular injection with either middle dose of MT-5625 or placebo
Toddler MT-5625 high dose	MT-5625 high dose	Toddler receiving intramuscular injection with either high dose of MT-5625 or placebo
Infant MT-5625 high dose	MT-5625 high dose	Infant receiving intramuscular injection with either high dose of MT-5625 or placebo
Adult MT-5625 high dose	MT-5625 high dose	Adult receiving intramuscular injection with either high dose of MT-5625 or placebo
Infant MT-5625 high dose	Placebo	Infant receiving intramuscular injection with either high dose of MT-5625 or placebo
Rotarix	Rotarix	Infant receiving oral administration with Rotarix
Infant MT-5625 low dose	Placebo	Infant receiving intramuscular injection with either low dose of MT-5625 or placebo
Infant MT-5625 middle dose	MT-5625 middle dose	Infant receiving intramuscular injection with either middle dose of MT-5625 or placebo

Primary Outcome Measures

Name	Time	Method
Proportion of subjects reporting adverse events.	Within 28 days after each vaccination
Proportion of subjects with local reactions and reactogenicity events.	Within 7 days after each vaccination

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with neutralizing antibody responses	Day 28 after each vaccination
Neutralizing antibody GMTs against rotavirus 28 days after each injection in adults, toddlers and infants.	Day 28 after each vaccination
Proportion of subjects with anti-MT-5625 IgG seroresponses	Day 28 after each vaccination
Anti-MT-5625 IgG geometric mean titers (GMTs) 28 days after each injection in adults, toddlers, and infants.	Day 28 after each vaccination

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

Recruitment & Eligibility

Study & Design

Trial Locations

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