Trials / Completed
CompletedNCT03268083
A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects
An Open-Label, Dose-Finding, Phase II Study to Evaluate the Immunogenicity and Safety of the Bioreactor-generated EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 2 to 35 Months Old
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Enimmune Corporation · Industry
- Sex
- All
- Age
- 2 Months – 6 Years
- Healthy volunteers
- Accepted
Summary
The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose) | Two vaccinations at 28 days apart |
| BIOLOGICAL | EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose) | Two vaccinations at 28 days apart |
| BIOLOGICAL | EV71 vaccine ([1 μg total protein ] per dose) | Two vaccinations at 28 days apart |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2017-08-01
- Completion
- 2017-12-01
- First posted
- 2017-08-31
- Last updated
- 2021-10-26
Locations
4 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT03268083. Inclusion in this directory is not an endorsement.