Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
- Conditions
- MeningitisMeningococcal Infections
- Interventions
- Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
- Registration Number
- NCT00850603
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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 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
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3 Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined 0.05 mL Intradermal arm (Menomune®) Group 5 Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined 0.15 mL Intradermal arm (Menomune®) Group 4 Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined 0.1 mL Intradermal arm (Menomune®) Group 1 Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined 0.5 mL Subcutaneous arm (Menomune® ) Group 2 Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined 0.1 mL Subcutaneous arm (Menomune®)
- Primary Outcome Measures
Name Time Method Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers Baseline to 28 days post vaccination Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. Baseline (Day 0) and Day 28 post-vaccination GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.
- Secondary Outcome Measures
Name Time Method Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. Day 0 to 7 days post-vaccination Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®