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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: |
NCT00351923 |
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Date of registration:
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12/07/2006 |
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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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Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes
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Scientific title:
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Open, Multicenter, Randomised, Controlled Phase IIIb Study Evaluating the Immunogenicity and Safety of Subcutaneous Versus Alternative Administration Route of Combined MeMuRu-OKA Vaccine to Healthy Children Aged 11 to 21 Months. |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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330 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00351923 |
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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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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children must be healthy and have a birth weight > 2000 g to participate
Exclusion Criteria:
- confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions,
neurological disorders, history of allergic disease or reaction, major congenital
defects, chronical administration of salicylates, and fever (axillary temperature ³
37.5°C at the time of vaccination) are excluding factors.
- Children from pregnant mothers who have a negative history of chickenpox are also
excluded from the study.
- Children must have received one dose (but not more) of MMR and of varicella at least
6 weeks before entering the study. They must not receive or have received other
non-registered drug or vaccine within 30 days prior to study start, or
immunosuppressants for more than 14 days.
- Immunoglobulins or any blood products are prohibited during the 6 months before and
during the study, as well as vaccine other than that foreseen by the protocol within
30 days before vaccination.
- Children must not have had measles, mumps, rubella or varicella/zoster, or have been
exposed to those diseases within 30 days prior to study start.
- New-born infants (< 5 weeks of age), pregnant women without previous exposure to
chickenpox, and immunodeficient persons cannot live in the same household as the
vaccinated child
Age minimum:
11 Months
Age maximum:
22 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Varicella
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Rubella
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Measles
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Mumps
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Intervention(s)
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Biological: MeMuRu-OKA (study vaccine)
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Primary Outcome(s)
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Seroconversion rates after vaccination
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Secondary Outcome(s)
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Antibody titres; safety: solicited local/ general, unsolicited AEs (42 days), SAEs (whole study)
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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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