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

Meningitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258856
• Other study ID #: MTA23
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2005
• Last updated: January 21, 2014
• Start date: January 2006
• Est. completion date: November 2007

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: November 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningococcal Infection
• Meningococcal Infections

Intervention

Biological:
• Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, Intramuscular
• Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, Intramuscular
• Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, Intramuscular
• Polysaccharide Diphtheria Conjugate Vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	7 or 14 days post-vaccination	No

External Links

•   Link
•   Link