Dose Comparison Study of Menactra® in US Children

Meningitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700635
• Other study ID #: MTA61
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2008
• Last updated: April 12, 2016
• Start date: June 2008
• Est. completion date: October 2009

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 333
• Est. completion date: October 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

Inclusion Criteria :

• Aged 2 to < 11 years on the day of inclusion.

• 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.

Exclusion Criteria :

• 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).

• 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.

Related Conditions & MeSH terms

• Meningitis
• Meningococcal Infection
• Meningococcal Infections
• Neisseria Meningitidis

Intervention

Biological:
• Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses Intramuscular
• Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 2 doses Intramuscular
• Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
0.5 mL, 1 dose Intramuscular

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
Primary	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	Percentage of Participants With Meningococcal Antibody Titers at = 4 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	Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® 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	Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination	Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.	7 days post-vaccination 1
Secondary	Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination	Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.	7 days post-vaccination 2

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