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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507738
• Other study ID #: MT-5625-01
• Status: Completed
• Phase: Phase 1
• Start date: July 3, 2018
• Est. completion date: June 28, 2019

Study information

• Verified date: August 2019
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 35 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• MT-5625 low dose
Intramuscular injection
• MT-5625 middle dose
Intramuscular injection
• MT-5625 high dose
Intramuscular injection
• Rotarix
Oral administration
• Placebo
Intramuscular injection

Locations

Country	Name	City	State
Australia	Investigational center	Adelaide
South Africa	Investigational center	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Australia,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with local reactions and reactogenicity events.		Within 7 days after each vaccination
Primary	Proportion of subjects reporting adverse events.		Within 28 days after each vaccination
Secondary	Proportion of subjects with anti-MT-5625 IgG seroresponses		Day 28 after each vaccination
Secondary	Proportion of subjects with neutralizing antibody responses		Day 28 after each vaccination
Secondary	Anti-MT-5625 IgG geometric mean titers (GMTs) 28 days after each injection in adults, toddlers, and infants.		Day 28 after each vaccination
Secondary	Neutralizing antibody GMTs against rotavirus 28 days after each injection in adults, toddlers and infants.		Day 28 after each vaccination