NCT00777790

Brief Summary

This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02. Primary Objective: To evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of Menactra® in naive adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
241

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

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

February 1, 2004

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 19, 2009

Completed
Last Updated

February 14, 2014

Status Verified

January 1, 2014

Enrollment Period

2 months

First QC Date

October 21, 2008

Results QC Date

December 2, 2008

Last Update Submit

January 21, 2014

Conditions

MeningitisMeningococcemia

Keywords

MeningitisMeningococcemiaNeisseria meningitidis

Outcome Measures

Primary Outcomes (1)

  • Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.

    Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.

    Day 0 and 8 and 28 days post-vaccination

Study Arms (3)

Menactra® Group

EXPERIMENTAL

Received Menactra® vaccine in Study MTA02

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Menomune® Group

EXPERIMENTAL

Received Menomune® vaccine in Study MTA02

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Control Group

EXPERIMENTAL

Meningococcal vaccine-naïve Control Group.

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Interventions

Meningococcal Polysaccharide Diphtheria Toxoid ConjugateBIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®
Menactra® Group

Eligibility Criteria

Age13 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participant is healthy, as determined by medical history and physical examination.
  • Participant is at least 13 years of age but not yet 22 years of age at time of enrollment.
  • For the Menactra® and Menomune® groups, participant received one dose of Menactra® or Menomune® in MTA02 trial and completed trial (2 blood samples, contacted for Month 6 safety follow up).
  • For the Control group, participant has no previous history of any meningococcal vaccination.
  • If \< 18 years of age, participant has signed Institutional Review Board (IRB) approved informed assent form and his/her parent/legal guardian has signed an IRB-approved informed consent form.
  • If ≥ 18 years of age, participant has signed an IRB-approved informed consent form.
  • Able to provide vaccination log.

You may not qualify if:

  • Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc).
  • Known or suspected impairment of immunologic function.
  • For the Menactra® and Menomune® groups, history of documented invasive meningococcal disease or previous meningococcal vaccination with the exception of meningococcal vaccination given as part of MTA02 trial.
  • For the Control group, history of documented invasive meningococcal disease or previous meningococcal vaccination.
  • Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
  • Antibiotic therapy within the 72 hours prior to vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn.
  • Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination.
  • Suspected or known hypersensitivity to any of the vaccine components.
  • Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures.
  • In females, a positive or equivocal urine pregnancy test at the time of vaccination.
  • Enrolled in another clinical trial.
  • Any condition, which, in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the vaccine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Atlanta, Georgia, 30322, United States

Location

Unknown Facility

Marietta, Georgia, 30062, United States

Location

Unknown Facility

Woburn, Massachusetts, 01801, United States

Location

Unknown Facility

Albany, New York, 12208, United States

Location

Unknown Facility

Akron, Ohio, 44308, United States

Location

Unknown Facility

Columbus, Ohio, 43205, United States

Location

Unknown Facility

Sellersville, Pennsylvania, 18960, United States

Location

Unknown Facility

Kingsport, Tennessee, 37660, United States

Location

Unknown Facility

Norfolk, Virginia, 23501, United States

Location

Related Publications (1)

  • Keyserling H, Papa T, Koranyi K, Ryall R, Bassily E, Bybel MJ, Sullivan K, Gilmet G, Reinhardt A. Safety, immunogenicity, and immune memory of a novel meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in healthy adolescents. Arch Pediatr Adolesc Med. 2005 Oct;159(10):907-13. doi: 10.1001/archpedi.159.10.907.

    PMID: 16203934RESULT

Related Links

MeSH Terms

Conditions

MeningitisMeningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System DiseasesNeisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Bacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

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

Study Officials

  • Medical Monitor

    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 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 22, 2008

Study Start

February 1, 2004

Primary Completion

April 1, 2004

Study Completion

April 1, 2005

Last Updated

February 14, 2014

Results First Posted

March 19, 2009

Record last verified: 2014-01

Locations

US(9)