Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Meningococcal Infections
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 170
- Primary Endpoint
- Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Time Frame: 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.
Time Frame: 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 Outcomes
- Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.(Day 0 to 7 days post-vaccination)