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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00314041 |
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Date of registration:
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10/04/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating the Tolerance of Conjugate Meningococcal C Vaccine in Infants
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Scientific title:
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A Randomized, Double-blind, Controlled, Active Comparator, Phase II Study to Assess the Tolerance and Immunogenicity of Conjugate Meningococcal C (MnCC) Vaccine in Infants When Administered in Conjunction With Primary DTP/Hib Vaccination at 2, 3, and 4 Months of Age. |
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Date of first enrolment:
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June 1997 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00314041 |
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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: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Phase:
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Phase 2
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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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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For United Kingdom, ukmedinfo@wyeth.com |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy infants 7-10 weeks of age eligible to receive routine immunization
Age minimum:
7 Weeks
Age maximum:
10 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Meningitis, Meningococcal
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Intervention(s)
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Biological: Meningococcal C
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Biological: DTP/Hib
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Primary Outcome(s)
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Antibody responses to MnCC and concomitant vaccines
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Secondary Outcome(s)
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Safety and reactogenicity
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Secondary ID(s)
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6029A1 D110 P500
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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