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Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00850603
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : April 30, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE February 24, 2009
First Posted Date  ICMJE February 25, 2009
Results First Submitted Date  ICMJE March 13, 2009
Results First Posted Date  ICMJE April 30, 2009
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE October 2002
Actual Primary Completion Date May 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2009)
  • Immunogenicity: To provide information concerning the immunogenicity of Menomune vaccine [ Time Frame: 28 days post vaccination ]
  • Safety: To provide information concerning the safety of Menomune [ Time Frame: 28 days post-vaccination and entire study duration ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2010)
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®
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
Official Title  ICMJE Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningococcal Infections
  • Meningitis
Intervention  ICMJE
  • Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
    0.5 mL, Subcutaneous
    Other Name: Menomune® - A/C/Y/W-135
  • Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
    0.1 mL, Subcutaneous
    Other Name: Menomune® - A/C/Y/W-135
  • Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
    0.05 mL, Intradermal
    Other Name: Menomune® - A/C/Y/W-135
  • Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
    0.1 mL, Intradermal
    Other Name: Menomune® - A/C/Y/W-135
  • Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
    0.15 mL, Intradermal
    Other Name: Menomune® - A/C/Y/W-135
Study Arms  ICMJE
  • Active Comparator: Group 1
    0.5 mL Subcutaneous arm (Menomune® )
    Intervention: Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
  • Experimental: Group 2
    0.1 mL Subcutaneous arm (Menomune®)
    Intervention: Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
  • Experimental: Group 3
    0.05 mL Intradermal arm (Menomune®)
    Intervention: Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
  • Experimental: Group 4
    0.1 mL Intradermal arm (Menomune®)
    Intervention: Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
  • Experimental: Group 5
    0.15 mL Intradermal arm (Menomune®)
    Intervention: Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2009)
170
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2004
Actual Primary Completion Date May 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00850603
Other Study ID Numbers  ICMJE MPT01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP