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OpenTrials
Completed

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

East Stroudsburg, Pennsylvania, 18301, United States

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

Biological

0.5 mL, Subcutaneous

Other names: Menomune® - A/C/Y/W-135

Primary outcomes

  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 outcomes

  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®

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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