Back to resultsSafety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
Primary Purpose
Meningococcal Infections, Meningitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Sponsored by
About this trial
This is an interventional prevention trial for Meningococcal Infections focused on measuring Menomune® - A/C/Y/W-135, Meningococcal Infections, Meningitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Group 5
Arm Description
0.5 mL Subcutaneous arm (Menomune® )
0.1 mL Subcutaneous arm (Menomune®)
0.05 mL Intradermal arm (Menomune®)
0.1 mL Intradermal arm (Menomune®)
0.15 mL Intradermal arm (Menomune®)
Outcomes
Primary Outcome Measures
Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
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.
GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.
Secondary Outcome Measures
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®
Full Information
NCT ID
NCT00850603
First Posted
February 24, 2009
Last Updated
April 12, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00850603
Brief Title
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
Official Title
Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Infections, Meningitis
Keywords
Menomune® - A/C/Y/W-135, Meningococcal Infections, Meningitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
0.5 mL Subcutaneous arm (Menomune® )
Arm Title
Group 2
Arm Type
Experimental
Arm Description
0.1 mL Subcutaneous arm (Menomune®)
Arm Title
Group 3
Arm Type
Experimental
Arm Description
0.05 mL Intradermal arm (Menomune®)
Arm Title
Group 4
Arm Type
Experimental
Arm Description
0.1 mL Intradermal arm (Menomune®)
Arm Title
Group 5
Arm Type
Experimental
Arm Description
0.15 mL Intradermal arm (Menomune®)
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Other Intervention Name(s)
Menomune® - A/C/Y/W-135
Intervention Description
0.5 mL, Subcutaneous
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Other Intervention Name(s)
Menomune® - A/C/Y/W-135
Intervention Description
0.1 mL, Subcutaneous
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Other Intervention Name(s)
Menomune® - A/C/Y/W-135
Intervention Description
0.05 mL, Intradermal
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Other Intervention Name(s)
Menomune® - A/C/Y/W-135
Intervention Description
0.1 mL, Intradermal
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Other Intervention Name(s)
Menomune® - A/C/Y/W-135
Intervention Description
0.15 mL, Intradermal
Primary Outcome Measure Information:
Title
Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Description
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.
Time Frame
Baseline to 28 days post vaccination
Title
Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Description
GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.
Time Frame
Baseline (Day 0) and Day 28 post-vaccination
Secondary Outcome Measure Information:
Title
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Description
Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®
Time Frame
Day 0 to 7 days post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc
Official's Role
Study Director
Facility Information:
City
East Stroudsburg
State/Province
Pennsylvania
ZIP/Postal Code
18301
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
We'll reach out to this number within 24 hrs