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Sponsored by: |
Shantha Biotechnics Limited |
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Information provided by: | Shantha Biotechnics Limited |
ClinicalTrials.gov Identifier: | NCT00674908 |
The objective of this study is to compare the Safety and Immunogenicity of a mixed sequence of 2 different pentavalent vaccines (Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib combination Vaccines) with single sequence of Shan 5 in infants.
Condition | Intervention | Phase |
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Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenzae Type B |
Biological: Shan 5 Biological: Easy Five |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Single Blind, Multicentric, Comparative, Vaccine Interchangeability Trial of Shan 5 (Liquid) and Easy Five (Liquid) [Diphtheria-Tetanus- Pertussis, Hepatitis B and Hib Pentavalent Combination Vaccines] in Indian Infants. |
Estimated Enrollment: | 144 |
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 |
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Shan 5: Experimental
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
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Biological: Shan 5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
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Easy 5: Active Comparator
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib conjugate pentavalent liquid combination vaccine
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Biological: Easy Five
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib conjugate pentavalent liquid combination vaccine
|
Ages Eligible for Study: | 6 Weeks to 8 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
India, Gujrat | |
Smt NHL Municipal Medical College and LG Hospital | |
Ahmedabad, Gujrat, India, 380006 | |
India, Karnataka | |
Kempegowda Institute of Medical Sciences | |
Bangalore, Karnataka, India, 560070 | |
India, Maharashtra | |
Deenanath Mangeshkar Hospital | |
Pune, Maharashtra, India, 411004 |
Study Director: | Raman Rao, MD | Shantha Biotechnics Limited |
Responsible Party: | Shantha Biotechnics Limited ( Head Clinical Research and Medical Affairs ) |
Study ID Numbers: | SBL/DTPwHB-Hib/INT/2007/0200 |
Study First Received: | May 6, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00674908 |
Health Authority: | India: Drugs Controller General of India |
Vaccine Prevention Diphtheria Tetanus Pertussis |
Hepatitis B Haemophilus influenzae type b Vaccine interchangeability Single vs mixed sequence 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 |