Skip to main content
OpenTrials
Completed

NCT Number: NCT00258856

Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®

The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will receive a dose of Menactra® vaccine.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jonesboro, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is healthy, as determined by medical history.
  • Subject is between the ages of 7 and 15 years (not yet 16 years).
  • For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
  • The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23.
  • A negative urine pregnancy test is required for menstruating female subjects.
  • Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.

Exclusion criteria

  • Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study)
  • History of documented invasive meningococcal disease
  • Received any other meningococcal vaccine
  • Received any vaccine in the 28-day period prior to enrollment
  • Received antibiotic therapy within the 72 hours prior to collection of a blood sample
  • Actively enrolled or scheduled to be enrolled in another clinical study
  • Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system)
  • Known or suspected impairment of immunologic function
  • Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion
  • Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment
  • Administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) 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.
  • Personal of family history of Guillain-Barres Syndrome
  • 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
  • Any condition which, in the opinion of the investigator, would pose a health risk to the participant.

Treatment and study plan

Polysaccharide Diphtheria Conjugate Vaccine

Biological

0.5 mL, Intramuscular

Other names: Menactra®

Primary outcomes

  1. Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 Days Post-booster or Post-primary Dose Vaccination.

    Time frame: 7 or 14 days post-vaccination

    Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination.

    Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Persistence of Bactericidal Antibodies in Children Aged 7 to 15 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 28, 2005
Registry last updated
Feb 14, 2014

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.

Published trials that share one or more normalized conditions with this study.