Trials / Completed
CompletedNCT01125527
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 700 (actual)
- Sponsor
- Novartis Vaccines · Industry
- Sex
- All
- Age
- 13 Months – 59 Months
- Healthy volunteers
- Accepted
Summary
This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib) | a single dose was administered |
| BIOLOGICAL | Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib) | a single dose was administered |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2009-10-01
- Completion
- 2010-04-01
- First posted
- 2010-05-18
- Last updated
- 2016-12-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01125527. Inclusion in this directory is not an endorsement.