Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan
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ClinicalTrials.gov Identifier: NCT01410474 |
Recruitment Status :
Completed
First Posted : August 5, 2011
Results First Posted : September 22, 2014
Last Update Posted : September 22, 2014
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Sponsor:
Novartis
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
Condition |
Bacterial Meningitis |
Intervention |
Biological: Meningococcal ACWY conjugate vaccine |
Enrollment | 341 |
Participant Flow
Recruitment Details | Subjects were enrolled at three study centres in Taiwan. |
Pre-assignment Details | All enrolled subjects were included in the trial. |
Arm/Group Title | 2-10 Years | 11-18 Years |
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Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. | Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. |
Period Title: Overall Study | ||
Started | 173 | 168 |
Completed | 173 | 167 |
Not Completed | 0 | 1 |
Reason Not Completed | ||
Withdrawal by Subject | 0 | 1 |
Baseline Characteristics
Arm/Group Title | 2-10 Years | 11-18 Years | Total | |
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Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. | Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. | Total of all reporting groups | |
Overall Number of Baseline Participants | 173 | 168 | 341 | |
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Analysis was done on all the enrolled subjects.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 173 participants | 168 participants | 341 participants | |
6.3 (2.6) | 14.0 (2.2) | 10.1 (4.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 173 participants | 168 participants | 341 participants | |
Female |
92 53.2%
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88 52.4%
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180 52.8%
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Male |
81 46.8%
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80 47.6%
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161 47.2%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Posting Director |
Organization: | Novartis Vaccines and Diagnostics |
EMail: | RegistryContactVaccinesUS@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT01410474 |
Other Study ID Numbers: |
V59_49 |
First Submitted: | August 3, 2011 |
First Posted: | August 5, 2011 |
Results First Submitted: | March 12, 2013 |
Results First Posted: | September 22, 2014 |
Last Update Posted: | September 22, 2014 |