Trials / Completed
CompletedNCT02152709
Study of Evaluating Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine
A Phase 3, Randomized, Controlled, and Blinded Clinical Trial to Evaluate Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine for Infants and Other Age Groups.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,537 (actual)
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention · Network
- Sex
- All
- Age
- 1 Day – 75 Years
- Healthy volunteers
- Accepted
Summary
The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 3 dose of 10µg/0.5ml hepatitis B vaccine | 3 dose of 10µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval. |
| BIOLOGICAL | 3 dose of 5µg/0.5ml hepatitis B vaccine | 3 dose of 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval. |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2010-03-01
- Completion
- 2010-10-01
- First posted
- 2014-06-02
- Last updated
- 2014-06-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02152709. Inclusion in this directory is not an endorsement.