Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®

Completed · Phase 4

Conditions studied: Meningococcal Infections, Meningitis

In brief

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

Key facts

Study ID

NCT00850603

Run by

Sanofi Pasteur, a Sanofi Company

People needed

170

Starts

2002-10-01

Expected to finish

2004-11-01

Last updated by the study team

2016-04-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — East Stroudsburg, Pennsylvania, United States

Full record on ClinicalTrials.gov

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