Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

Tetanus Clinical Trial

Official title:

Immunogenicity and Safety of Meningococcal (Groups A, C, Y, and W-135) Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Adolescents in the US When Administered Concomitantly With Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap Vaccine)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00777257
• Other study ID #: MTA21
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2008
• Last updated: January 21, 2014
• Start date: April 2005
• Est. completion date: September 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 study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.

Primary Objective:

To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately.

Secondary Objective:

To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1345
• Est. completion date: September 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria :

• Healthy as determined by medical history and physical examination.

• Aged = 11 to 17 years at the time of study vaccination on Day 0.

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

• Informed assent form that has been approved by the IRB signed by the subject.

• Subject (female) agrees to use measures to prevent pregnancy during the study.

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 = 100.4°F (= 38.0°C) at the time of enrolment.

• History of documented invasive meningococcal disease or previous meningococcal vaccination.

• History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.

• Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting <7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment.

• Received antibiotic therapy within the 72 hours prior to vaccination on Day 0.

• Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study.

• Suspected or known hypersensitivity to either of the two study vaccines or their components.

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

• Enrolled in another clinical trial.

• Diagnosed with 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.

• For all females, a positive or equivocal urine pregnancy test at time of study vaccination.

• Nursing mothers.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Meningitis
• Meningococcemia
• Pertussis
• Tetanus
• Whooping Cough

Intervention

Biological:
• T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular
• Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.
Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular
• Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap
Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) 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 at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine.		Day 0 to Day 28 post-vaccination	No
Primary	Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.		Day 0 and Day 28 post-vaccination	No
Primary	Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.		Day 0 and Day 28 Post-vaccination	No
Secondary	Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively.	Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.	0 to 7 days post-vaccination	Yes

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