Trials / Completed
CompletedNCT01986335
Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
Phase 3 of Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (actual)
- Sponsor
- PT Bio Farma · Industry
- Sex
- All
- Age
- 6 Weeks – 11 Weeks
- Healthy volunteers
- Accepted
Summary
The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.
Detailed description
This trial was randomized, double blind, prospective intervention and multi centers. Total 600 subject (6-11 weeks of ages) followed this trial, divided into 3 groups, each group consists of 200 subjects. A number of 342 subjects were recruited in Bandung, while 258 subjects were recruited in Jakarta.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DTP/HB/Hib Vaccine | DPT/HB/Hib vaccine (Bio Farma) |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2013-01-01
- Completion
- 2013-01-01
- First posted
- 2013-11-18
- Last updated
- 2013-11-18
Locations
6 sites across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT01986335. Inclusion in this directory is not an endorsement.