Skip to main content
OpenTrials
Completed

NCT Number: NCT00269477

Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®

The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the antibody response will be evaluated in a subset of these participants who will receive a booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who have not been previously vaccinated with a meningococcal vaccine or had documented meningitis disease who will also receive a dose of Menactra® vaccine.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–23 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Atlanta, Georgia, 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 15 and 23 years (not yet 24 years).
  • For subjects who participated in Study MTA02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
  • Did not participate in Study MTA19 (a subset of subjects from Study MTA02 who had been recruited for a follow-up challenge study)
  • Subject or parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.
  • Before recruitment for the second part of the study, subjects should be thoroughly screened to ensure that they are able to comply with protocol specifications
  • A negative urine pregnancy test is required for menstruating female subjects.

Exclusion criteria

  • History of documented invasive meningococcal disease.
  • Received any other meningococcal vaccine
  • Received any vaccine (other than desensitization therapy for allergies) in the 28-day period prior to enrollment
  • Scheduled to receive any vaccination in the 28-day period after enrollment
  • Received systemic 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, hematologic, 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
  • Administration of immune globulin, other blood products, or corticosteroid within 3 months 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 or family history of Guillain-Barre 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

Meningococcal polysaccharide diphtheria toxoid conjugate

Biological

0.5 mL, Intramuscular

Other names: Menactra®

Primary outcomes

  1. Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination.

    Time frame: 28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)

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

    Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination.

Other outcomes

  1. Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions

    Time frame: Day 0 to 7 post-vaccination

    Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Persistence of Bactericidal Antibodies in Adolescents and Adults Aged 15 to 23 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 23, 2005
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.

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