Trials / Completed
CompletedNCT01430611
Study of Sanofi Pasteur and Lanzhou Institute's Meningococcal (Group A and C) Polysaccharide Vaccine in Children
Safety and Immunogenicity of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine Versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine in Children 2-6 Years of Age in China
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 666 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 2 Years – 6 Years
- Healthy volunteers
- Accepted
Summary
This study is part of the post-licensure commitment to evaluate the safety and immunogenicity of Meningo A+C vaccine in healthy Chinese children 2 to 6 years of age. Primary Objective: To demonstrate the non-inferiority in terms of seroconversion rate for serogroups A and C, 30 days after a single dose of Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine versus Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine. Secondary Objective: * To describe the immunogenicity for serogroups A and C, 30 days after administration of the study vaccines given as a single dose. * To describe the full reactogenicity profile after administration of the study vaccines given as a single dose.
Detailed description
Eligible participants will receive one injection of either Sanofi Pasteur Meningococcal (Groups A and C) Polysaccharide Vaccine or Lanzhou Institute for Biological Products Meningococcal (Groups A and C) Polysaccharide Vaccine and will be monitored for safety and immunogenicity for up to 30 days post-vaccination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Meningococcal (Groups A and C) Polysaccharide Vaccine | 0.5 mL, Subcutaneous |
| BIOLOGICAL | Meningococcal (Groups A and C) Polysaccharide Vaccine | 0.5 mL, Subcutaneous |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2012-08-01
- Completion
- 2012-11-01
- First posted
- 2011-09-08
- Last updated
- 2014-05-08
- Results posted
- 2014-05-08
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01430611. Inclusion in this directory is not an endorsement.