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

Phase 2

Completed

• Conditions: Meningococcal Infection; Meningitis

• Registration Number: NCT01442675
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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.

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Disposition First Submitted: 2012-12-03
• Disposition First Submitted QC: 2012-12-03
• Disposition First Posted: 2012-12-05
• Status Verified: 2014-11
• Results First Submitted: 2014-11-11
• Results First Submitted QC: 2014-11-17
• Last Update Submitted: 2014-11-17
• Results First Posted: 2014-11-18
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 834

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®	Day 28 post-vaccination	Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)

Secondary Outcome Measures

Name	Time	Method
Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®	Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination	Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).; Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®	Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination	Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).; Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®	Day 6 and Day 28 post-vaccination	Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®	Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination	Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®	Day 6 and Day 28 post-vaccination	Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.
Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®	Day 0 up to Day 7 post-vaccination	Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - \>100 mm. Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity.