Status:
COMPLETED
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningococcal Infections
Meningitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunoge...
Detailed Description
This trial will provide a proof of concept that a dose range of Menomune given ID can induce an immune response that is comparable to standard dosing by the SC route, and is equivalent or superior to ...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- 18 to 55 years of age.
- Willing to return for 3 follow-up visits and comply with a 30 day follow-up period.
- Signed an informed consent form.
- Exclusion Criteria :
- Allergy to any component of the vaccine and latex.
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00850603
Start Date
October 1 2002
End Date
November 1 2004
Last Update
April 14 2016
Active Locations (1)
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1
East Stroudsburg, Pennsylvania, United States, 18301