Study of a Booster Dose of Meningococcal Diphtheria Toxoid Conjugate Vaccine in Adolescents

Meningitis Clinical Trial

Official title:

Antibody Responses to a Booster Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, Menactra® in Adolescents Who Previously Received Menomune® or Menactra®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777790
• Other study ID #: MTA19
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2008
• Last updated: January 21, 2014
• Start date: February 2004
• Est. completion date: April 2005

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

This study was designed to evaluate the antibody response to a Menactra® booster dose in participants who previously received one dose of Menactra® or Menomune® as adolescents 3 years earlier in Study MTA02.

Primary Objective:

To evaluate the antibody responses to a booster dose of a tetravalent meningococcal diphtheria toxoid conjugate vaccine (Menactra®) in participants who had previously received Menactra® or Menomune® as adolescents in the MTA02 Study and antibody responses to a dose of Menactra® in naive adolescents.

Description:

All subjects were given a single boosting dose of Menactra® to evaluate the kinetics of the response, the magnitude and the avidity of the antibody produced.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: April 2005
• Est. primary completion date: April 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 21 Years

Eligibility

Inclusion Criteria :

• Participant is healthy, as determined by medical history and physical examination.

• Participant is at least 13 years of age but not yet 22 years of age at time of enrollment.

• For the Menactra® and Menomune® groups, participant received one dose of Menactra® or Menomune® in MTA02 trial and completed trial (2 blood samples, contacted for Month 6 safety follow up).

• For the Control group, participant has no previous history of any meningococcal vaccination.

• If < 18 years of age, participant has signed Institutional Review Board (IRB) approved informed assent form and his/her parent/legal guardian has signed an IRB-approved informed consent form.

• If = 18 years of age, participant has signed an IRB-approved informed consent form.

• Able to provide vaccination log.

Exclusion Criteria :

• Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric etc).

• Known or suspected impairment of immunologic function.

• Acute medical illness with or without fever within the last 72 hours or an oral temperature = 100.4ºF (= 38.0ºC) at the time of inclusion.

• For the Menactra® and Menomune® groups, history of documented invasive meningococcal disease or previous meningococcal vaccination with the exception of meningococcal vaccination given as part of MTA02 trial.

• For the Control group, history of documented invasive meningococcal disease or previous meningococcal vaccination.

• Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six 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 vaccination or antibiotic therapy within the 72 hours prior to having any blood sample drawn.

• Received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination.

• Suspected or known hypersensitivity to any of the vaccine components.

• Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures.

• In females, a positive or equivocal urine pregnancy test at the time of vaccination.

• Enrolled in another clinical trial.

• 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.

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, Intramuscular
• Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
• Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, 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, 

References & Publications (1)

Keyserling H, Papa T, Koranyi K, Ryall R, Bassily E, Bybel MJ, Sullivan K, Gilmet G, Reinhardt A. Safety, immunogenicity, and immune memory of a novel meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titers (GMTs) of Serum Bactericidal Activity for Each of the 4 Vaccine Serogroups.	Geometric mean titers and their 95% confidence interval of serum bactericidal activity for the 4 vaccine serogroups before vaccination, at 8 days post- and 28 days post-booster dose of Menactra vaccine or a primary dose of Menactra vaccine in the meningococcal vaccine-naïve Control group.	Day 0 and 8 and 28 days post-vaccination	No

External Links

•   Link
•   Link