Phase 4
N=170
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
Meningococcal Infections · Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT00850603 ↗Enrolled (actual)
170
Serious AEs
0.6%
Results posted
Apr 2009
Primary outcome: Primary: Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers — 85; 61; 61; 76 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- May 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers |
85; 61; 61; 76; 84; 79 | — |
| PRIMARY Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. |
462.4; 320.4; 267.0; 381.6; 261.6; 5496.3 | — |
| SECONDARY Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. |
8; 5; 9; 10; 18; 0 | — |
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 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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00850603). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.