Trials / Completed
CompletedNCT00777257
Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine
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)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,345 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 11 Years – 17 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. | Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular |
| BIOLOGICAL | 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 |
| BIOLOGICAL | 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 |
Timeline
- Start date
- 2005-04-01
- Primary completion
- 2007-03-01
- Completion
- 2007-09-01
- First posted
- 2008-10-22
- Last updated
- 2014-02-14
- Results posted
- 2009-12-31
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00777257. Inclusion in this directory is not an endorsement.