Phase 4
Completed N=353
A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
Source: ClinicalTrials.gov NCT02203357 ↗Enrolled (actual)
353
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults — 1847.99; 839.27; 1244.8 mIU/ml — p=<0.05
◆ Published Evidence
Emerging
15citations · ~2 / year
Comparative immunogenicity of hepatitis B vaccine with different dosages and schedules in healthy young adults in China.
Summary
The objective of this study is to evaluate the immunogenicity and Anti-HBV antibody persistence of hepatitis B vaccine with different doses and schedules. Hepatitis B vaccine with the regimens of 20μg, 0-1-6 mon and 60μg,0-1 or 0-2 mon will be administered to young adults, and the comparative immunogenicity among the three groups will be measured at 1 mon post-a series vaccination, 1- and 2-year after the first dose of the regimen. Furthermore, the safety of hepatitis B vaccine with different doses and schedules will also be evaluated.
Linked Publications
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Comparative immunogenicity of hepatitis B vaccine with different dosages and schedules in healthy young adults in China.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults |
427.46; 89.74; 89.80 | — |
| SECONDARY Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults |
427.46; 89.74; 89.80 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects aged between 16 and 25 as established by medical history and clinical examination
- Written informed consent will be obtained from each subject before the serum screening of HBV markers
- Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody
- Have never been immunized with HBV vaccine before
Exclusion Criteria
- Subject has a medical history of allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Autoimmune disease or immunodeficiency
- Women with pregnant
- Bleeding disorder diagnosed by a doctor
- Chronic diseases: hepatitis, tumor, tuberculosis,et.al
- Any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment
- Subjects had a medical history of serious adverse reactions to vaccines
Data sourced from ClinicalTrials.gov (NCT02203357) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.