Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
April 12, 2016 updated by: Sanofi Pasteur, a Sanofi Company
Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
- Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
- Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
- Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
- Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
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.
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
East Stroudsburg, Pennsylvania, United States, 18301
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
0.5 mL Subcutaneous arm (Menomune® )
|
0.5 mL, Subcutaneous
Other Names:
0.1 mL, Subcutaneous
Other Names:
0.05 mL, Intradermal
Other Names:
0.1 mL, Intradermal
Other Names:
0.15 mL, Intradermal
Other Names:
|
|
Experimental: Group 2
0.1 mL Subcutaneous arm (Menomune®)
|
0.5 mL, Subcutaneous
Other Names:
0.1 mL, Subcutaneous
Other Names:
0.05 mL, Intradermal
Other Names:
0.1 mL, Intradermal
Other Names:
0.15 mL, Intradermal
Other Names:
|
|
Experimental: Group 3
0.05 mL Intradermal arm (Menomune®)
|
0.5 mL, Subcutaneous
Other Names:
0.1 mL, Subcutaneous
Other Names:
0.05 mL, Intradermal
Other Names:
0.1 mL, Intradermal
Other Names:
0.15 mL, Intradermal
Other Names:
|
|
Experimental: Group 4
0.1 mL Intradermal arm (Menomune®)
|
0.5 mL, Subcutaneous
Other Names:
0.1 mL, Subcutaneous
Other Names:
0.05 mL, Intradermal
Other Names:
0.1 mL, Intradermal
Other Names:
0.15 mL, Intradermal
Other Names:
|
|
Experimental: Group 5
0.15 mL Intradermal arm (Menomune®)
|
0.5 mL, Subcutaneous
Other Names:
0.1 mL, Subcutaneous
Other Names:
0.05 mL, Intradermal
Other Names:
0.1 mL, Intradermal
Other Names:
0.15 mL, Intradermal
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline to 28 days 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.
|
Baseline (Day 0) and Day 28 post-vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Time Frame: Day 0 to 7 days post-vaccination
|
Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®
|
Day 0 to 7 days post-vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Primary Completion (Actual)
May 1, 2003
Study Completion (Actual)
November 1, 2004
Study Registration Dates
First Submitted
February 24, 2009
First Submitted That Met QC Criteria
February 24, 2009
First Posted (Estimate)
February 25, 2009
Study Record Updates
Last Update Posted (Estimate)
April 14, 2016
Last Update Submitted That Met QC Criteria
April 12, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPT01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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