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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01003431 |
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Date of registration:
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27/10/2009 |
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Primary sponsor: |
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Public title:
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A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
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Scientific title:
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A Randomized, Open-Label Clinical Study to Assess the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine When Administered Concomitantly With RotaTeq™ or Rotarix™ in Healthy Infants in South Africa |
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Date of first enrolment:
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December 2009 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01003431 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy infants
Exclusion Criteria:
- History of abdominal disorders, intestinal folding, or abdominal surgery
- Impaired immune system
- Prior administration of any rotavirus vaccine or DTwP/DTaP
- Fever of >= 38.1C (100.5F) at the time of vaccination
- History of prior rotavirus infection, chronic diarrhea, or failure to thrive
- Evidence of active gastrointestinal illness
Age minimum:
6 Weeks
Age maximum:
12 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diphtheria
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Pertussis
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Rotavirus Gastroenteritis
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Tetanus
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Intervention(s)
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Biological: Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)
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Biological: Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
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Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
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Primary Outcome(s)
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Geometric Mean Titer (GMT) for Pertussis Toxoid
[Time Frame: 1 month post dose 3]
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Secondary Outcome(s)
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Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A
[Time Frame: 1 month post dose 3]
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Secondary ID(s)
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2009_683
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V260-036
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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