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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00269477
Other study ID # MTA35
Secondary ID
Status Completed
Phase Phase 2
First received December 22, 2005
Last updated April 12, 2016
Start date December 2005
Est. completion date December 2007

Study information

Verified date April 2016
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 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.


Recruitment information / eligibility

Status Completed
Enrollment 145
Est. completion date December 2007
Est. primary completion date February 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years to 23 Years
Eligibility 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.

Study Design

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


Intervention

Biological:
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
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
Other Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Day 0 to 7 post-vaccination Yes
Primary 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. 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.
28 days post-vaccination (5 years after Menactra® or Menomune® vaccination) No
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