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Phase 2 Study of Immunogenicity and Safety of DPT/HB/Hib (Bio Farma) Vaccine Compared to DTP/HB (Bio Farma) Vaccine Given Simultaneously With Hib (Registered) Vaccine in Indonesian Infants
The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.
Details
| Lead sponsor | PT Bio Farma |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 220 |
| Start date | 2011-07 |
| Completion | 2012-01 |
Conditions
- Healthy
Interventions
- DTP/HB/Hib vaccine
- DTP/HB and Hib vaccine
Primary outcomes
- Protectivity of DTP/HB/Hib (Bio Farma) vaccine — 4 months
Percentage of infants with anti diphteria titer and anti tetanus titer \>= 0.01 IU/ml, AntiHbs titer \>=10mlIU/ml, and antiPRP-TT titer \>= 0,15ug/ml 28 days after the last injection (third) in DPT/HB/Hib liquid vaccine group
Countries
Indonesia