Trials / Completed
CompletedNCT03188692
Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants
Phase 3 Study of BK1310 Intramuscular Injection in Healthy Infants
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Tanabe Pharma Corporation · Industry
- Sex
- All
- Age
- 2 Months – 43 Months
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DPT-IPV-Hib (Combined Vaccine) | 0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. |
Timeline
- Start date
- 2017-06-23
- Primary completion
- 2017-11-02
- Completion
- 2018-08-09
- First posted
- 2017-06-15
- Last updated
- 2026-01-06
- Results posted
- 2025-01-03
Locations
3 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03188692. Inclusion in this directory is not an endorsement.