Phase 2
N=333
Dose Comparison Study of Menactra® in US Children
Meningitis · Meningococcal Infection · Neisseria Meningitidis
Bottom Line
View on ClinicalTrials.gov: NCT00700635 ↗Enrolled (actual)
333
Serious AEs
2.1%
Results posted
Dec 2010
Primary outcome: Primary: Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination — 59; 36; 65; 83 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate (Biological)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination |
59; 36; 65; 83; 67; NA | — |
| SECONDARY Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination |
73; 58; 79; 94; 79; NA | — |
| SECONDARY Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination. |
9.97; 5.59; 12.7; 24.3; 13.6; NA | — |
| SECONDARY Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination |
67; 60; 67; 53; 53; 58 | — |
| SECONDARY Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination |
60; 64; 48; 52; 0; 1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00700635). 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.