Trials / Completed
CompletedNCT00772070
Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine
Antibody Responses to a Reduced Dose of Menomune® in Children Who Previously Received an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine, TetraMenD
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 173 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 3 Years – 5 Years
- Healthy volunteers
- Accepted
Summary
This study was designed to simulate meningococcal challenge by vaccination with a fractional combined dose of unconjugated meningococcal polysaccharides A, C, Y, and W-135, Menomune® in children who were vaccinated with one dose of TetraMenD at least 18 months earlier. Primary Objective: To evaluate and compare the antibody responses to a reduced dose of Menomune® in participants who had previously received a tetravalent meningococcal diphtheria toxoid conjugate vaccine to those responses in participants who received the same reduced dose of Menomune® but had not previously received any meningococcal vaccine.
Detailed description
This was a two stage, controlled, open-label trial. Stage I of the trial simulated meningococcal challenge Stage II of the trial evaluated the meningococcal vaccine naïve participants from Stage I, who had also received a reduced dose of Menomune® vaccine in Stage I and were administered a full dose of Menactra® vaccine 6 months later.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®) | 0.05 mL, Subcutaneous |
| BIOLOGICAL | A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®) | 0.05 mL, Subcutaneous |
Timeline
- Start date
- 2003-03-01
- Primary completion
- 2003-08-01
- Completion
- 2004-05-01
- First posted
- 2008-10-15
- Last updated
- 2014-02-14
- Results posted
- 2009-05-14
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00772070. Inclusion in this directory is not an endorsement.