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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
110
Intramuscular injection
Intramuscular injection
Intramuscular injection
Investigational center
Adelaide, Australia
Investigational center
Johannesburg, South Africa
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
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
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Oral administration
Intramuscular injection