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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00514709 |
DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance.
Primary Objectives:
Secondary Objective:
To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when administered concomitantly with OPV.
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Pertussis Hepatitis B Heamophilus Influenza |
Biological: DTaP HB PRP~T Combined Vaccine Biological: DTaP-HB-PRP~T vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 2133 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: DTaP HB PRP~T Combined Vaccine
0.5 mL dose, IM
|
2: Experimental |
Biological: DTaP-HB-PRP~T vaccine
0.5 mL dose, IM
|
This study will assess the immunogenicity and reactogenicity of the investigational DTaP-HB-PRP~T combined vaccine when given as a booster dose, concomitantly with OPV, in Filipino children previously primed at 6, 10, and 14 weeks with the investigational DTaP-HB-PRP~T combined vaccine or Tritanrix-HepB/Hib™ vaccine and having received a first dose of HB vaccine (Recomvax B™) at birth in a previous study.
Ages Eligible for Study: | 12 Months to 18 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Philippines, Alabang | |
Muntinlupa City, Alabang, Philippines | |
Philippines, Alabang Junction Alabang | |
Muntinlupa City, Alabang Junction Alabang, Philippines | |
Philippines, Bayanan Annex | |
Muntinlupa City, Bayanan Annex, Philippines | |
Philippines, Cupang | |
Muntinlupa City, Cupang, Philippines | |
Philippines, Filinvest | |
Muntinlupa City, Filinvest, Philippines | |
Philippines, Putatan | |
Muntinlupa City, Putatan, Philippines | |
Philippines, Tunasan | |
Muntinlupa City, Tunasan, Philippines |
Study Director: | Clinical Trials | sanofi pasteur |
Responsible Party: | Sanofi Pasteur, Inc. ( Medical Monitor ) |
Study ID Numbers: | AL204 |
Study First Received: | August 9, 2007 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00514709 History of Changes |
Health Authority: | Philippines: Department of Health |
Diphtheria Tetanus Pertussis Hepatitis B Hansenula (HB) Haemophilus influenzae type b |
Bacterial Infections Liver Diseases Haemophilus Influenzae Hepatitis, Viral, Human Whooping Cough Cough Orthomyxoviridae Infections Diphtheria Tetanus Gram-Negative Bacterial Infections Virus Diseases |
Hepatitis Antibodies Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Influenza, Human Hepatitis B DNA Virus Infections Clostridium Infections Immunoglobulins |
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 |