Dose Comparison Study of Menactra® in US Children
Exploratory Evaluation of a Two-dose Schedule Versus a One-dose Schedule of Menactra® (Meningococcal [Groups A, C, Y and W 135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) in Children in the US
1 other identifier
interventional
333
1 country
15
Brief Summary
To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children. Primary Objective: To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2008
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
December 23, 2010
CompletedApril 14, 2016
April 1, 2016
11 months
May 7, 2008
December 11, 2010
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
30 days post-vaccination
Secondary Outcomes (4)
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
30 days post-vaccination
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
30 days post-vaccination
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
7 days post-vaccination 1
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
7 days post-vaccination 2
Study Arms (3)
Menactra® Group 1
EXPERIMENTALParticipants aged 2 to \< 4 years
Menactra® Group 2
EXPERIMENTALParticipants aged 4 to \< 6 years
Menactra® Group 3
ACTIVE COMPARATORParticipants aged 6 to \< 11 years
Interventions
0.5 mL, 2 doses Intramuscular
Eligibility Criteria
You may qualify if:
- Provision of assent form signed by the subject (depending on age) and informed consent form signed by the parent(s) or another legally acceptable representative.
- Subject and parent/legal guardian able to attend all scheduled visits and comply with all trial procedures.
You may not qualify if:
- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
- 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 trial 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.
- Suspected or known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction 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.
- Receipt of 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 trial vaccination.
- Planned receipt of any vaccine within the 4 weeks following any trial vaccination(s).
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Boca Raton, Florida, 33433, United States
Unknown Facility
Viera, Florida, 32940, United States
Unknown Facility
Woburn, Massachusetts, 01801, United States
Unknown Facility
Las Vegas, Nevada, 89102, United States
Unknown Facility
Cleveland, Ohio, 44121, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15241, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Kingsport, Tennessee, 37660, United States
Unknown Facility
Fort Worth, Texas, 76135, United States
Unknown Facility
San Antonio, Texas, 78205, United States
Unknown Facility
Orem, Utah, 84057, United States
Unknown Facility
Midlothian, Virginia, 23113, United States
Unknown Facility
Spokane, Washington, 99202, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2008
First Posted
June 19, 2008
Study Start
June 1, 2008
Primary Completion
May 1, 2009
Study Completion
October 1, 2009
Last Updated
April 14, 2016
Results First Posted
December 23, 2010
Record last verified: 2016-04