Trials / Completed
CompletedNCT01977196
The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)
Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 6 Weeks – 11 Weeks
- Healthy volunteers
- Accepted
Summary
The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.
Detailed description
This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DPT/HepatitisB/Hib vaccine | DPT/HepatitisB/Hib vaccine (Bio Farma) |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2013-11-06
- Last updated
- 2013-11-06
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT01977196. Inclusion in this directory is not an endorsement.