Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) With Pentabio® Vaccine Primed With Recombinant Hepatitis B
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 540
Summary
- Conditions
- Immunogenicity
- Safety
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Subjects neonates: Randomized, double blind, 2 arms parallel groups, prospective intervention StudyMasking: Double (Participant, Investigator)Masking Description: Randomized, double blind, 2 arms parallel group, prospective intervention study This study will do the lot to lot consistency and will be compared to registered productPrimary Purpose: Prevention
Participation Requirements
- Age
- Younger than 3 years
- Gender
- Both males and females
Description
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants
Tracking Information
- NCT #
- NCT04071379
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Eddy Fadliyana Hasan Sadikin General Hospital
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