Seasonal Influenza Clinical Trial
Official title:
An Randomized, Double-blind, Controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35months
Verified date | May 2024 |
Source | Sinovac Biotech Co., Ltd |
Contact | Lei Wang |
Phone | 18986142864 |
372491281[@]qq.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A phase III clinical trial of the study of quadrivalent influenza vaccine developed by Sinovac Biotech will be conducted in Chinese children aged 6 to 35 months. The trial is an randomized, double-blind and active controlled study. The objective of this study is to evaluate the Immunogenicity and safety of the vaccine.
Status | Recruiting |
Enrollment | 3300 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 35 Months |
Eligibility | Inclusion Criteria: - Healthy infants aged 6-35 months; - Proven vaccination certificate and birth certificate; - The subjects' guardians can understand and voluntarily sign the informed consent form. Exclusion Criteria: - Received any circulating seasonal influenza vaccine prior to enrollment or had an influenza vaccine schedule during the study; - Suffering from seasonal influenza in the past 6 moths; - Axillary temperature >37.0°C; - History of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema and asthma; - Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; - Severe chronic diseases(Such as down syndrome, diabetes, sickle cell anaemia or neurological disorders); - Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; - Autoimmune disease (such as systemic lupus erythematosus) or immunodeficiency / immunosuppression (such as HIV, after organ transplantation) - Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or splenectomy resulting from any condition; - Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; - Continuous use of corticosteroids or other immunosuppressive agents for = 14 days within the past 6 months (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) and cytotoxic therapy in the past 6 months; - Acute diseases or acute exacerbation of chronic diseases in the past 3 days; - Receipt of blood products within in the past 3 months; - Receipt of other investigational drugs in the past 30 days; - Receipt of attenuated live vaccines in the past 14 days; - Receipt of inactivated or subunit vaccines in the past 7 days; - Participated in other clinical trials before enrollment and in the follow-up period, or plans to participate in other clinical trials during the clinical trial; - According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial |
Country | Name | City | State |
---|---|---|---|
China | Huoqiu County Center for Disease Control and Prevention | Lu'an | Anhui |
China | Zhushan County Center for Diseases Control and Prevention | Shiyan | Hubei |
China | Laohekou Center for Disease Control and Prevention | Xiangyang | Hubei |
China | Nanzhang County Center for Disease Prevention and Control | Xiangyang | Hubei |
China | Digui County Center for Disease Control and Prevention | Yichang | Hubei |
Lead Sponsor | Collaborator |
---|---|
Sinovac Biotech Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroconversion rates of HI antibody | Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer <1:10 and post-vaccination titer =1:40, and Significant increase was defined as pre-vaccination titer=1:40 and = 4-fold increase of post-vaccination titer. | 28 days after full schedule immunization | |
Primary | Geometric Mean Titers (GMTs) of HI antibody | Anti-influenza antibody levels were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata. | 28 days after full schedule immunization | |
Primary | Number of Participants With Seroprotection to Influenza Vaccine Antigens | Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer =1:40 at pre-vaccination and at post-final vaccination. | 28 days after full schedule immunization | |
Secondary | GMIs of HI antibody | Anti-influenza antibody were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata. GMI is the increase fold of GMT post vaccination compared with pre vaccination | 28 days after full schedule immunization | |
Secondary | Incidence of adverse reactions | Incidence of adverse reaction 0-30 days after each dose | 0-30 days after each dose | |
Secondary | Incidence of adverse reactions | Incidence of adverse reaction 0-7 days after each dose | 0-7 days after each dose | |
Secondary | Incidence of Serious adverse events | Incidence of serious adverse events from beginning of vaccination until 6 months after the last dose | Since the beginning of vaccination until 6 months after the last dose | |
Secondary | Incidence of AESI | Incidence of AESI since the beginning of vaccination until 6 months after the last dose | since the beginning of vaccination until 6 months after the last dose |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01209780 -
Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age
|
Phase 3 | |
Completed |
NCT01180621 -
Evaluation of Seasonal Influenza Vaccine for 2010-2011 in Young Children
|
Phase 2 | |
Completed |
NCT01206686 -
The Effect of Time-Slot Scheduling on Flu Vaccination Rates
|
N/A | |
Completed |
NCT04133584 -
The Immunogenicity and Safety of the Vaccination of Inactivated Enterovirus 71 Vaccine and Seasonal Influenza Vaccine
|
Phase 4 | |
Completed |
NCT05566639 -
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older
|
Phase 3 | |
Completed |
NCT00957996 -
Safety Study of IV Peramivir in Hospitalized Subjects With Confirmed or Suspected Influenza
|
Phase 3 | |
Completed |
NCT01072799 -
Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine
|
Phase 2 | |
Completed |
NCT01207232 -
The Effect of a Planning Prompt on Seasonal Influenza Vaccination Rates
|
N/A | |
Completed |
NCT04997239 -
A Clinical Trial of Quadrivalent Influenza Vaccine in Children Aged 3-8 Years Old
|
Phase 4 | |
Completed |
NCT05512494 -
Lot-to-lot Consistency of Quadrivalent Influenza Vaccine (Split Virion), Inactivated
|
Phase 4 | |
Completed |
NCT01011582 -
Characteristics and Outcomes of Intensive Care Unit Patients Admitted With Novel H1N1 Influenza or Seasonal Influenza
|
N/A | |
Terminated |
NCT00958776 -
A Study to Evaluate the Efficacy and Safety of IV Peramivir in Addition to Standard of Care Compared to Standard of Care Alone in Adults and Adolescents Who Are Hospitalized Due to Influenza
|
Phase 3 | |
Completed |
NCT00560066 -
Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
|
Phase 4 | |
Active, not recruiting |
NCT05397223 -
A Study of Modified mRNA Vaccines in Healthy Adults
|
Phase 1 | |
Completed |
NCT04896086 -
First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults
|
Phase 1 | |
Completed |
NCT01342796 -
Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects
|
Phase 2 | |
Completed |
NCT01344057 -
Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2011-2012
|
Phase 2 | |
Completed |
NCT00903552 -
Trial to Evaluate Safety and Immunogenicity of Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant)
|
Phase 2 | |
Completed |
NCT05827068 -
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
|
Phase 1/Phase 2 | |
Completed |
NCT05415462 -
A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults
|
Phase 3 |