Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
NCT ID: NCT00850603
Last Updated: 2016-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
170 participants
INTERVENTIONAL
2002-10-31
2004-11-30
Brief Summary
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The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal (ID) routes at different dosages
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Detailed Description
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Subjects will be randomized according to a computer-generated randomization schedule to receive the vaccine by SC injection or by ID injection at different dosages.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1
0.5 mL Subcutaneous arm (Menomune® )
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.5 mL, Subcutaneous
Group 2
0.1 mL Subcutaneous arm (Menomune®)
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.1 mL, Subcutaneous
Group 3
0.05 mL Intradermal arm (Menomune®)
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.05 mL, Intradermal
Group 4
0.1 mL Intradermal arm (Menomune®)
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.1 mL, Intradermal
Group 5
0.15 mL Intradermal arm (Menomune®)
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.15 mL, Intradermal
Interventions
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Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.5 mL, Subcutaneous
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.1 mL, Subcutaneous
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.05 mL, Intradermal
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.1 mL, Intradermal
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.15 mL, Intradermal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing to return for 3 follow-up visits and comply with a 30 day follow-up period.
* Signed an informed consent form.
Exclusion Criteria
* Known or suspected immunodeficiency or receipt of immunosuppressive therapy or blood products within the previous two months.
* History of serious chronic diseases (such as cardiac or renal disease).
* Acute febrile illness at the time of visit.
* Pregnancy.
* Receipt of any vaccine within the 28 days prior to enrollment.
* Receipt of meningococcal vaccine (example in Military) within the past 5 years or history of meningococcal disease.
18 Years
55 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc
Locations
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East Stroudsburg, Pennsylvania, United States
Countries
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Related Links
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Related Info
Other Identifiers
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MPT01
Identifier Type: -
Identifier Source: org_study_id
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