Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age

Meningitis Clinical Trial

Official title:

Safety and Immunogenicity of a Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine (TetraMenD) In Toddlers 9 to 18 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643916
• Other study ID #: MTA26
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2008
• Last updated: January 21, 2014
• Start date: December 2004
• Est. completion date: October 2007

Study information

• Verified date: January 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age.

Primary Objective:

To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to <6 years of age.

Description:

This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: October 2007
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 5 Years

Eligibility

Inclusion Criteria :

• Aged either 9, 12, 15 or 18 months of age or 3 to < 6 years of age on the day of inclusion.

• Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian

• Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria :

• History of a serious chronic disease that could interfere with trial conduct or completion.

• Known or suspected impairment of immunologic function.

• Acute medical illness with or without fever within the last 72 hours, or rectal temperature = 100.4°F (= 38.0°C) or axillary temperature = 99.4°F (= 37.4°C) on the day of inclusion.

• History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination.

• Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.

• Antibiotic therapy within the 72 hours prior to having any blood sample drawn.

• Received or scheduled to receive any vaccine in the 28-day period prior to receipt of either dose of the study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 28-day period after receipt of either dose of the study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or after receiving the trial vaccine.

• Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.

• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination

• Unable to attend one or more of the scheduled visits or to comply with the study procedures.

• Participation in another clinical trial in the 4 weeks preceding enrollment.

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

• 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
• Meningococcal Infection
• Meningococcal Infections

Intervention

Biological:
• Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 9 and 12 months)
• Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 9 and 15 months)
• Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 12 and 15 months)
• Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 15 months)
• Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 18 months)
• A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
0.5 mL, Subcutaneous (at 3 years to <6 years of age)

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	Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.	Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.	Day 0 up to 7 post-vaccination	No
Primary	Percentage of Participants With a =8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.		Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2	No

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