Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    MPT01
Previous Study | Return to List | Next Study

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 )

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


Condition or disease Intervention/treatment Phase
Meningococcal Infections Meningitis Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
Study Start Date : October 2002
Actual Primary Completion Date : May 2003
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
0.5 mL Subcutaneous arm (Menomune® )
Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.5 mL, Subcutaneous
Other Name: Menomune® - A/C/Y/W-135

Experimental: Group 2
0.1 mL Subcutaneous arm (Menomune®)
Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.1 mL, Subcutaneous
Other Name: Menomune® - A/C/Y/W-135

Experimental: Group 3
0.05 mL Intradermal arm (Menomune®)
Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.05 mL, Intradermal
Other Name: Menomune® - A/C/Y/W-135

Experimental: Group 4
0.1 mL Intradermal arm (Menomune®)
Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.1 mL, Intradermal
Other Name: Menomune® - A/C/Y/W-135

Experimental: Group 5
0.15 mL Intradermal arm (Menomune®)
Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.15 mL, Intradermal
Other Name: Menomune® - A/C/Y/W-135




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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®



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850603


Locations
Layout table for location information
United States, Pennsylvania
East Stroudsburg, Pennsylvania, United States, 18301
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Layout table for investigator information
Study Director: Medical Director Sanofi Pasteur Inc

Additional Information:
Layout table for additonal information
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00850603     History of Changes
Other Study ID Numbers: MPT01
First Posted: February 25, 2009    Key Record Dates
Results First Posted: April 30, 2009
Last Update Posted: April 14, 2016
Last Verified: April 2016

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Menomune® - A/C/Y/W-135
Meningococcal Infections
Meningitis

Additional relevant MeSH terms:
Layout table for MeSH terms
Meningitis
Meningococcal Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections