Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | October 2002 |
| End Date: | November 2004 |
Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
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 immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard
dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose)
and a low dose (2/10th of standard dose) subcutaneously.
The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal
(ID) routes at different dosages
intradermally and low-dose subcutaneously versus standard subcutaneously. This study will
describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard
dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose)
and a low dose (2/10th of standard dose) subcutaneously.
The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal
(ID) routes at different dosages
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 a low dose given SC.
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.
an immune response that is comparable to standard dosing by the SC route, and is equivalent
or superior to a low dose given SC.
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.
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.
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