Trials / Completed
CompletedNCT03507738
Safety and Immunogenicity of MT-5625 in Healthy Adults, Toddlers and Infants
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Tanabe Pharma Corporation · Industry
- Sex
- All
- Age
- 6 Weeks – 35 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MT-5625 low dose | Intramuscular injection |
| BIOLOGICAL | MT-5625 middle dose | Intramuscular injection |
| BIOLOGICAL | MT-5625 high dose | Intramuscular injection |
| BIOLOGICAL | Rotarix | Oral administration |
| BIOLOGICAL | Placebo | Intramuscular injection |
Timeline
- Start date
- 2018-07-03
- Primary completion
- 2019-06-28
- Completion
- 2019-06-28
- First posted
- 2018-04-25
- Last updated
- 2019-08-06
Locations
2 sites across 2 countries: Australia, South Africa
Source: ClinicalTrials.gov record NCT03507738. Inclusion in this directory is not an endorsement.