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Sponsors and Collaborators: |
Bandim Health Project Danish Council for Development Research Novo Nordisk Fonden til Lægevidenskabens Fremme Medical Research Council Laboratories, Gambia |
Information provided by: | Bandim Health Project |
ClinicalTrials.gov Identifier: | NCT00168558 |
The specific aims are to examine in Guinea-Bissau:
Condition | Intervention | Phase |
Measles |
Biological: Measles vaccine |
Phase IV |
MedlinePlus related topics: | Measles |
ChemIDplus related topics: | Diphtheria-Pertussis-Tetanus Vaccine Measles Vaccine |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Measles Vaccination in Guinea-Bissau. Strategies to Reduce Disease Burden and Improve Child Survival |
Estimated Enrollment: | 5755 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
Standard titre Edmonston-Zagreb measles vaccine at 4½ and 9 months of age
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Biological: Measles vaccine
The children will be randomised to the following three arms: Arm 1 - Very early two-dose: V (EZ) 4½ mo of age + V (EZ) 9 mo of age. Arm 2 - 9 months one- or two-dose: V (SW) 9 mo of age + V (SW)/or nothing 18 mo of age. Arm 3 - 9 months one- or two-dose: V (EZ) 9 mo of age + V (EZ)/or nothing 18 mo of age. V = measles vaccination, EZ = standard titre Edmonston-Zagreb measles vaccine, SW = standard titre Schwarz measles vaccine |
2: Active Comparator
Standard titre Schwarz measles vaccine at 9 months of age
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Biological: Measles vaccine
The children will be randomised to the following three arms: Arm 1 - Very early two-dose: V (EZ) 4½ mo of age + V (EZ) 9 mo of age. Arm 2 - 9 months one- or two-dose: V (SW) 9 mo of age + V (SW)/or nothing 18 mo of age. Arm 3 - 9 months one- or two-dose: V (EZ) 9 mo of age + V (EZ)/or nothing 18 mo of age. V = measles vaccination, EZ = standard titre Edmonston-Zagreb measles vaccine, SW = standard titre Schwarz measles vaccine |
3: Active Comparator
Standard titre Edmonston-Zagreb measles vaccine at 9 months of age
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Biological: Measles vaccine
The children will be randomised to the following three arms: Arm 1 - Very early two-dose: V (EZ) 4½ mo of age + V (EZ) 9 mo of age. Arm 2 - 9 months one- or two-dose: V (SW) 9 mo of age + V (SW)/or nothing 18 mo of age. Arm 3 - 9 months one- or two-dose: V (EZ) 9 mo of age + V (EZ)/or nothing 18 mo of age. V = measles vaccination, EZ = standard titre Edmonston-Zagreb measles vaccine, SW = standard titre Schwarz measles vaccine |
Show Detailed Description |
Ages Eligible for Study: | 4 Months to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Guinea-Bissau, Apartado 861 | |||||
Bandim Health Project | |||||
Bissau, Apartado 861, Guinea-Bissau, 1004 Bissau Codex |
Bandim Health Project |
Danish Council for Development Research |
Novo Nordisk |
Fonden til Lægevidenskabens Fremme |
Medical Research Council Laboratories, Gambia |
Study Director: | Peter Aaby, MSc, Dr. Med | Bandim Health Project, Statens Serum Institut, Denmark |
Principal Investigator: | May-Lill Garly, PHD, DTM&H | Bandim Health Project, Statens Serum Institut, Denmark |
Statens Serum Institut, Denmark 
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Responsible Party: | Bandim Health Project ( May-Lill Garly ) |
Study ID Numbers: | RUF-91134-2601-Twodose2, RUF-91134-2601, NOVO-2624, LÆGEVIDENSKABENS FREMME-2613, LÆGEVIDENSKABENS FREMME-2623 |
First Received: | September 9, 2005 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00168558 |
Health Authority: | Guinea-Bissau: Ministry of Health; Gambia: MRC Ethics Committee |
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