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Sponsored by: |
Shantha Biotechnics Limited |
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Information provided by: | Shantha Biotechnics Limited |
ClinicalTrials.gov Identifier: | NCT00877357 |
A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenzae Type B |
Biological: Shan 5 |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Open Label Multicentric Randomized Phase IV Post Marketing Safety, Immunogenicity and Lot-to-Lot Consistency Analysis of Shan 5 [DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine] in Indian Infants |
Estimated Enrollment: | 3000 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Shan 5 Lot No 1: Experimental |
Biological: Shan 5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
|
Shan 5 Lot No 2: Experimental |
Biological: Shan 5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
|
Shan 5 Lot No 3: Experimental |
Biological: Shan 5
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid 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:
Contact: Mandeep S Dhingra, MD | +91-40-66301000 ext 1801 | drmandeep@shanthabiotech.co.in |
India, UT | |
School of Public Health, Post Graduate Institute of Medical Education and Research | Recruiting |
Chandigarh, UT, India, 160012 | |
Contact: Madhu Gupta, MD +91-172-2755223 madhugupta21@gmail.com | |
Principal Investigator: Madhu Gupta, MD |
Study Director: | Raman Rao, MD | Shantha Biotechnics Limited |
Responsible Party: | Shantha Biotechnics Limited ( VP, Scientific and Medical Affairs ) |
Study ID Numbers: | SBL/DTPwHBHib/WHOCON/2008/0100 |
Study First Received: | April 6, 2009 |
Last Updated: | May 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00877357 History of Changes |
Health Authority: | India: Drugs Controller General of India |
Vaccine Prevention Diphtheria Tetanus Pertussis Hepatitis B |
Haemophilus influenzae type b Lot Consistency Long Term Immunogenicity Reactogenicity Healthy infants |
Bacterial Infections Liver Diseases Haemophilus Influenzae Hepatitis, Viral, Human Whooping Cough Cough Healthy Orthomyxoviridae Infections Diphtheria Tetanus Gram-Negative Bacterial Infections |
Virus Diseases Hepatitis Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Influenza, Human Hepatitis B DNA Virus Infections Clostridium Infections |
Bacterial Infections RNA Virus Infections Liver Diseases Hepatitis, Viral, Human Whooping Cough Orthomyxoviridae Infections Diphtheria Tetanus Infection Hepadnaviridae Infections Actinomycetales Infections Gram-Negative Bacterial Infections |
Virus Diseases Hepatitis Bordetella Infections Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Corynebacterium Infections Hepatitis B Influenza, Human DNA Virus Infections Clostridium Infections |