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Sponsored by: |
Shantha Biotechnics Limited |
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Information provided by: | Shantha Biotechnics Limited |
ClinicalTrials.gov Identifier: | NCT00617812 |
The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule.
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenzae Type B |
Biological: Shan5 |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Multicentric Study to Evaluate the Immunogenicity and Safety of Indigenously Developed DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine (Shan 5) in Indian Infants. |
Estimated Enrollment: | 160 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Shan5: Experimental |
Biological: Shan5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
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Ages Eligible for Study: | 6 Weeks to 8 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
India, Andhra Pradesh | |
Deccan College of Medical Sciences | |
Hyderabaad, Andhra Pradesh, India, 500058 | |
India, Gujrat | |
Ankur Institute of Child Health | |
Ahmedabad, Gujrat, India, 380009 | |
India, Karnataka | |
JSS Medical College | |
Mysore, Karnataka, India, 570015 | |
India, West Bengal | |
Institute of Child Health | |
Kolkata, West Bengal, India, 700017 |
Study Director: | Raman Rao, MD | Shantha Biotechnics Limited, Hyderabad, India |
Responsible Party: | Shantha Biotechnics Limited ( Head Clinical Research and Medical Affairs ) |
Study ID Numbers: | SBL/DTPwHB-Hib/PMS/2007/0100 |
Study First Received: | February 6, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00617812 |
Health Authority: | India: Drugs Controller General of India |
Vaccine Prevention Diphtheria Tetanus |
Pertussis Hepatitis B Haemophilus influenzae type b Healthy infants |
Bacterial Infections Liver Diseases Haemophilus influenzae Hepatitis, Viral, Human Whooping Cough Cough Healthy Orthomyxoviridae Infections Diphtheria Tetanus Whooping cough |
Gram-Negative Bacterial Infections Virus Diseases Hepatitis Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Hepatitis B Influenza, Human DNA Virus Infections Clostridium Infections |
Bordetella Infections RNA Virus Infections Corynebacterium Infections |
Infection Hepadnaviridae Infections Actinomycetales Infections |