The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)
NCT01977196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2013-11-06
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.
Conditions
- Healthy
Interventions
- BIOLOGICAL
-
DPT/HepatitisB/Hib vaccine
DPT/HepatitisB/Hib vaccine (Bio Farma)
Sponsors & Collaborators
-
PT Bio Farma
lead INDUSTRY
Principal Investigators
-
Kusnandi Rusmil, PhD · Faculty of Medicine UNPAD
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 6 Weeks
- Max Age
- 11 Weeks
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2011-07-31
- Completion
- 2011-07-31
Countries
- Indonesia
Study Locations
More Related Trials
-
Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants
NCT00169442 ·Status: COMPLETED ·Phase: PHASE3
-
Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib
NCT00332566 ·Status: COMPLETED ·Phase: PHASE3
-
Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.
NCT00316680 ·Status: TERMINATED ·Phase: PHASE3
-
Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants
NCT06690515 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Immune Memory Foll Pry Vaccination With DTPw-HBV/Hib Vaccine Formulation; Immuno & Reacto of Booster Dose at 15-18 Mths
NCT00158808 ·Status: COMPLETED ·Phase: PHASE2
-
Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine
NCT00289796 ·Status: COMPLETED ·Phase: PHASE2
-
Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine
NCT00325143 ·Status: COMPLETED ·Phase: PHASE3
-
Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children
NCT00611559 ·Status: COMPLETED ·Phase: PHASE4
-
Phase 3 Study of BK1310 in Healthy Infants
NCT02992925 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age
NCT00379977 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
NCT01125527 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
NCT01453998 ·Status: COMPLETED ·Phase: PHASE2
-
Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants
NCT00320463 ·Status: COMPLETED ·Phase: PHASE3
-
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
NCT00325156 ·Status: COMPLETED ·Phase: PHASE4
-
Assess Safety & Reactogenicity of GSK Biologicals' Hib Vaccine Co-administered With or Without Chinese DTPw Vaccine
NCT00158795 ·Status: COMPLETED ·Phase: PHASE4
-
Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants
NCT00348881 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
NCT00317109 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
NCT00627458 ·Status: COMPLETED ·Phase: PHASE2
-
Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC
NCT00322335 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly
NCT01457495 ·Status: COMPLETED ·Phase: PHASE2
-
Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants
NCT00291967 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
NCT01470287 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
NCT00879827 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
NCT00534833 ·Status: COMPLETED ·Phase: PHASE3
-
To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines
NCT00366366 ·Status: COMPLETED ·Phase: PHASE3