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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Meningococcal Infection

Meningitis

Treatments

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00269477

MTA35

Details and patient eligibility

About

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.

Enrollment

145 patients

Sex

All

Ages

15 to 23 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

145 participants in 4 patient groups

Menactra® Vaccine Group 1

Experimental group

Description:

Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.

Treatment:

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Menactra® Vaccine Group 2

Experimental group

Description:

Treatment:

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Meningococcal Vaccine-naive Group 3

Active Comparator group

Description:

Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.

Treatment:

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Meningococcal Vaccine-naive Group 4

Active Comparator group

Description:

Treatment:

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Trial contacts and locations

Data sourced from clinicaltrials.gov

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