NCT00850603

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
2 months until next milestone

Results Posted

Study results publicly available

April 30, 2009

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

February 24, 2009

Results QC Date

March 13, 2009

Last Update Submit

April 12, 2016

Conditions

Meningococcal InfectionsMeningitis

Keywords

Menomune® - A/C/Y/W-135Meningococcal InfectionsMeningitis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.

    Day 0 to 7 days post-vaccination

Study Arms (5)

Group 1

ACTIVE COMPARATOR

0.5 mL Subcutaneous arm (Menomune® )

Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined

Group 2

EXPERIMENTAL

0.1 mL Subcutaneous arm (Menomune®)

Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined

Group 3

EXPERIMENTAL

0.05 mL Intradermal arm (Menomune®)

Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined

Group 4

EXPERIMENTAL

0.1 mL Intradermal arm (Menomune®)

Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined

Group 5

EXPERIMENTAL

0.15 mL Intradermal arm (Menomune®)

Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined

Interventions

Meningococcal Polysaccharide Groups A\C\Y\W-135 CombinedBIOLOGICAL

0.5 mL, Subcutaneous

Also known as: Menomune® - A/C/Y/W-135
Group 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

East Stroudsburg, Pennsylvania, 18301, United States

Location

Related Links

MeSH Terms

Conditions

Meningococcal InfectionsMeningitis

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsNeuroinflammatory DiseasesNervous System Diseases

Results Point of Contact

Title
Medical Director
Organization
Sanofi Pasteur Inc
RegistryContactUs@sanofipasteur.com

Study Officials

  • Medical Director

    Sanofi Pasteur Inc

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 25, 2009

Study Start

October 1, 2002

Primary Completion

May 1, 2003

Study Completion

November 1, 2004

Last Updated

April 14, 2016

Results First Posted

April 30, 2009

Record last verified: 2016-04

Locations

US(1)