Study of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01442675
First received: September 26, 2011
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

The purpose of this trial is to describe the safety and antibody response to revaccination with Menactra vaccine in persons who received their first dose at ≥11 years of age.

Primary Objective:

- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by serum bactericidal assay using human complement (SBA-HC), induced by Menactra vaccine in subjects who were first vaccinated with Menactra 4-6 years ago.

Secondary Objective:

- To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens collected 6 days post-vaccination in a subset of study population.

Observational Objective:

- To describe the rates of immediate reactions, solicited injection-site and systemic reactions, unsolicited adverse events and serious adverse events following vaccination.


Condition Intervention Phase
Meningitis
Meningococcal Infection
Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Single Dose of Menactra® Vaccine 4-6 Years After Prior Menactra Vaccine

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Antibody titers at ≥ 1:8 for meningococcal serogroups A, C, Y, and W-135 in serum specimens collected 28 days post vaccination [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
    Antibody titers measured by serum bactericidal assay using human complement (SBA-HC)


Secondary Outcome Measures:
  • Serum bactericidal assay using human complement (SBA-HC) antibody titers ≥ 1:8 for meningococcal serogroups A, C, Y, and W-135 in serum specimens collected 6 days post vaccination. [ Time Frame: Day 6 post-vaccination ] [ Designated as safety issue: No ]

Enrollment: 835
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meningococcal vaccine Group
Participants must have received Menactra vaccine 4 to 6 years prior to enrollment
Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
0.5 mL, Intramuscular
Other Name: Menactra®

Detailed Description:

All participants will receive one dose of Menactra vaccine at their first clinic visit. There will be a telephone safety follow-up contact at six months post-vaccination.

  Eligibility

Ages Eligible for Study:   15 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Received Menactra 4 to 6 years prior to enrollment, at an age ≥11 years, and is < 56 years of age on the day of enrollment.
  • Informed consent form has been signed and dated by the subject or by the subject and the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence for at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. Females who are pre-menarche or post-menopausal for at least 1 year, or surgically sterile will not be excluded.
  • Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
  • History of documented invasive meningococcal disease.
  • Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study.
  • Suspected or known hypersensitivity to latex or to any of the components of Menactra vaccine, or history of a life-threatening reaction to Menactra vaccine or to a vaccine containing any of the same substances.
  • Receipt of any meningococcal vaccine since receipt of a single dose of Menactra vaccine 4-6 years prior to enrollment.
  • Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before the Day 28 visit; except that influenza vaccine may have been received between 30 and 15 days (but no less than 15 days) before receiving study vaccine.
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
  • History of laboratory-confirmed seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the subject.
  • Personal history of Guillain-Barré syndrome (GBS).
  • Laboratory-confirmed thrombocytopenia, which may be a contraindication for IM vaccination, at the discretion of the Investigator.
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator.
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
  • Receipt of oral or injectable antibiotic therapy within the 72 hours prior to the first blood draw.
  • Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. A prospective subject should not be enrolled in the study until the condition has resolved or the febrile event has subsided.
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442675

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
San Diego, California, United States, 92103
United States, Kentucky
Bardstown, Kentucky, United States, 40004
Crestview Hills, Kentucky, United States, 41017
United States, Massachusetts
Spokane, Massachusetts, United States, 99202
Woburn, Massachusetts, United States, 01801
United States, Michigan
Niles, Michigan, United States, 49120
Stevensville, Michigan, United States, 49127
United States, New York
Rochester, New York, United States, 14618
United States, Ohio
Cleveland, Ohio, United States, 44121
United States, Pennsylvania
Sellersville, Pennsylvania, United States, 18960
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Utah
Layton, Utah, United States, 84041
Orem, Utah, United States, 84057
United States, Virginia
Midlothian, Virginia, United States, 23113
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01442675     History of Changes
Other Study ID Numbers: MTA77, U1111-1117-7012
Study First Received: September 26, 2011
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Meningitis
Meningococcal Infection
Menactra®

Additional relevant MeSH terms:
Infection
Meningitis
Meningococcal Infections
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on October 22, 2014