Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® Three Years Earlier in Study MTA26

Meningitis Clinical Trial

Official title:

Antibody Persistence and Booster Dose Response in Subjects Who Received Menactra® (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) Three Years Earlier in Study MTA26

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700713
• Other study ID #: MTA62
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2008
• Last updated: January 16, 2016
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: January 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Study will evaluate the persistence of antibodies approximately three years after an initial dose of Menactra® vaccine in toddlers who participated in study MTA26 (NCT00643916) and age-matched Menactra naive participants.

Objectives:

• To assess the persistence of antibody responses three years after one or two doses of Menactra® vaccine in subjects who participated in study MTA26.

• To describe the antibody responses to a single dose of Menactra® vaccine in subjects who had previously received one or two doses of Menactra® vaccine and in Menactra® vaccine-naïve subjects.

• To describe the safety profile of a single dose of Menactra® vaccine in subjects.

Description:

Subjects that received Menactra® vaccine in study MTA26 (NCT00643916) and age-matched Menactra naive participants will receive a single dose of Menactra® on Day 0. They will be evaluated for immunogenicity and safety post-vaccination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria :

• Subjects received one or two doses of Menactra® vaccine in study MTA26 and provided a blood sample after the last dose received

• At 3 to < 6 years of age and were never vaccinated against meningococcal disease (with either the study vaccine or another vaccine).

• Informed consent form signed and dated by the parent(s) or another legally acceptable representative.

• Subject and parent/legal guardian able to attend all scheduled visits and comply with all study procedures.

Exclusion Criteria :

• Participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first study vaccination

• Planned participation in another clinical trial during the present trial period.

• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.

• Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccine or to a product containing any of the substances present in the study vaccine.

• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.

• Received blood or blood-derived products in the past 3 months.

• Received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first study vaccination.

• Planned receipt of any vaccine within the 4 weeks following the study vaccination.

• Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBs antigen), or hepatitis C seropositivity.

• History of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically).

• Thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination.

• Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws.

• Personal or family history of Guillain-Barré Syndrome (GBS).

• Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

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
• Meningococcemia

Intervention

Biological:
• Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
• Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM
• Meningococcal polysaccharide diphtheria toxoid conjugate
0.5 mL, IM

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	Geometric Mean Antibody Titers to Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®.	Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC).	Day 0 (pre-vaccination) and Day 30 post-vaccination	No
Other	Percentage of Participants Experiencing Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®	Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Vomiting, Drowsiness, Anorexia, Irritability, Arthralgia, and Diarrhea. Grade 3 Solicited Injection-site: Pain - Incapacitating, unable to perform usual activities; Erythema and Swelling - =2.0 in. Grade 3 Solicited systemic: Fever (Temperature) ->39.0°C (>102.2°F); Headache - Prevents daily activities; Vomiting - =3 episodes per 24 hours; Drowsiness - Disabling, dozing off or falling asleep while engaged in usual activities; Anorexia - Skips =3 meals; Irritability - >3 hours duration; Arthralgia - Unwilling to move due to pain; and Diarrhea - = 5 episodes per 24 hours.	Day 0 up to Day 7 post-vaccination	No
Primary	Percentage of Participants With Serum Meningococcal Serogroups A, C, Y, and W-135 Bactericidal Antibody Titers = 1:4 and = 1:8 Before and Following Vaccination With Menactra®	Antibody titers to meningococcal serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (SBA-HC). Bactericidal antibody persistence to meningococcal serogroups was defined as as pre-vaccination titers of =1:4 and =1:8. Booster response to a single Menactra vaccine dose was defined as antibody titers of =1:4 and =1:8 30 days post-booster vaccination.	Day 0 (pre-vaccination) and Day 30 post-vaccination	No

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