Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®

Meningitis Clinical Trial

Official title:

Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850603
• Other study ID #: MPT01
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2009
• Last updated: April 12, 2016
• Start date: October 2002
• Est. completion date: November 2004

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: November 2004
• Est. primary completion date: May 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningococcal Infections

Intervention

Biological:
• Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.5 mL, Subcutaneous
• Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.1 mL, Subcutaneous
• Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.05 mL, Intradermal
• Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.1 mL, Intradermal
• Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.15 mL, Intradermal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 28 days post vaccination	No
Primary	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.	Baseline (Day 0) and Day 28 post-vaccination	No
Secondary	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®	Day 0 to 7 days post-vaccination	Yes

External Links

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