Healthy
Conditions
Keywords
whole virus, inactivated, influenza, H5N1 vaccine, safety, immunogenicity
Brief summary
Influenza is an acute respiratory infection caused by influenza virus with high incidence and serious complications even causing death. According to the announcement released by the World Health Organization (WHO), the number of global annual influenza case was 0.6 to 1.2 billion and 0.5 to 1 million people died. The emergence of a new subtype of influenza virus may cause an influenza pandemic with occurence once every 10 to 50 years which cause serious adverse consequences for human health and social welfare worldwide. From 1997 to 2003，the H5N1 virus infection has increased highly and gradually spreaded to Europe, Africa and other countries and regions. High mortality caused by H5N1 virus has attracted the WHO and national government great attention. So it is meaningful to develop vaccine to provide effective antibody to reduce the number of infections. The objective of this study is to evaluate the safety and preliminary immunogenicity of a whole virus inactivated influenza H5N1 vaccine.
Interventions
BIOLOGICAL7.5μg /0.5ml
whole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml, two doses, 21 days interval
BIOLOGICAL15.0μg /0.5ml
whole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml, two doses, 21 days interval
BIOLOGICAL30.0μg /0.5ml
whole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml, two doses, 21 days interval
BIOLOGICAL0/0.5ml placebo
0/0.5ml placebo, two doses, 21 days interval
Sponsors
Wuhan Institute of Biological Products Co., Ltd
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Healthy subjects aged from 12 to 60 years old of normal intelligence; * The subjects' guardians are able to understand and sign the informed consent; * Subjects established as healthy after medical history questioning, physical examination and clinical decision; * Subjects who can comply with the requirements of the clinical trial protocol; * Subjects who have never received influenza H5N1 vaccine and other preventive products; * Subjects with temperature ≤37°C on axillary setting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the safety of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years | 21 days after the first dose | Frequency of systemic and local adverse reactions within 21 days after the first doses of whole virus inactivated influenza H5N1 vaccine in healthy adolescents aged from 12-17 years and adults aged from 18-60 years |
| the immunogenicity of the vaccine after first dose | on day 21±3 days | the seroconversion rate and GMFI of antibodies on day 21 after first dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years |
| the immunogenicity of the vaccine after second dose | on day 42±7 days | the seroconversion rate and GMFI of antibodies on day 21 after second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years |
| the immunogenicity of the vaccine after whole immunization | 3 months after second dose (±14 days) | the seroconversion rate and GMFI of antibodies 3 months after the second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| abnormal change of hematological examination and the function of liver and kidney after first dose | 3 days after first dose | abnormal change of hematological examination and the function of liver and kidney 3 days after first dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years |
| abnormal change of hematological examination and the function of liver and kidney after second dose | 3 days after second dose | abnormal change of hematological examination and the function of liver and kidney 3 days after second dose with different formulation vaccines in healthy adolescents aged from 12-17 years and adults aged from 18-60 years |
Countries
China
Outcome results
None listed