Phase 4
N=1,345
Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
Meningitis · Meningococcemia · Pertussis · Tetanus · Diphtheria
Bottom Line
View on ClinicalTrials.gov: NCT00777257 ↗Enrolled (actual)
1,345
Serious AEs
0.3%
Results posted
Dec 2009
Primary outcome: 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. — 92; 94; 93; 80 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. (Biological); Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. (Biological); Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap (Biological)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Mar 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
92; 94; 93; 80; 84; 87 | — |
| PRIMARY Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. |
0.2; 0.3; 56.2; 7.9; 49.8; 38.2 | — |
| PRIMARY Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. |
15.3; 14.0; 20.7; 88.0; 73.4; 107.4 | — |
| 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. |
87; 84; 0; 10; 9; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00777257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.