East Stroudsburg, Pennsylvania, 18301, United States
NCT Number: NCT00850603
Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
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
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Biological0.5 mL, Subcutaneous
Other names: Menomune® - A/C/Y/W-135
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.
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®
Sponsors and collaborators
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Industry
Registry information
Official study title
Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
Important dates
- Study start
- 2002
- Primary completion
- 2003
- Study completion
- 2004
- First posted
- Feb 25, 2009
- Registry last updated
- Apr 14, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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