Influenza Clinical Trial
Official title:
A Randomized, Controlled, Multicenter Phase 4 Clinic Trial to Evaluate the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine (Split Virion),Inactivated
Verified date | October 2022 |
Source | China National Biotec Group Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Subjects will be recruited and divided into 3 groups: 1. Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine; 2. Control Group A (378 subjects): EV71 vaccine only; 3. Control Group B (378 subjects): influenza vaccine only; All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.
Status | Completed |
Enrollment | 1134 |
Est. completion date | August 10, 2021 |
Est. primary completion date | January 6, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 11 Months |
Eligibility | Inclusion Criteria: - subjects aged from 6-11 months old at the date of recruitment; - with informed consent signed by parent(s) or guardians; - parent(s) or guardians are able to attend all planned clinical appointments and comply with all study instructions; - subjects not receive any vaccination within 14 days at the date of recruitment; - subjects have not been vaccinated with EV71 vaccine, seasonal flu vaccine; - subjects with no medical history of EV71 infection; - axillary temperature =37.0? Exclusion Criteria: - subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness; - allergic to any ingredient of vaccine or with allergy history to any vaccine; - subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone); - administration of immunoglobulins within 30 days prior to this study; - acute febrile disease(temperature = 37.0°C) or infectious disease; - have a clearly diagnosed history of thrombocytopenia or other coagulopathy, - may cause contraindications for subcutaneous injection; - any serious chronic illness, acute infectious diseases, or respiratory diseases; - severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications; - any kind of infectious, purulent, or allergic skin diseases; - any other factor that makes the investigator determines the subject is unsuitable for this study. |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang provincial center for disease control and prevention | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
China National Biotec Group Company Limited | Changchun Institute of Biological Products Co., Ltd., Guizhou Center for Disease Control and Prevention, Henan Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Peking University, Wuhan Institute of Biological Products Co., Ltd, Zhejiang Provincial Center for Disease Control and Prevention |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroconversion rate I | the rate of positive seroconversion against EV71 | Baseline (before vaccination) and 1 month after the last dose | |
Primary | Seroconversion rate II | the rate of positive seroconversion against Influenza A (H3N2, H1N1) and B Type viruses | Baseline (before vaccination ) and 1 month after the last dose | |
Primary | Geometric mean titer (GMT) I | Measure neutralizing antibody titers against EV71 | Baseline (before vaccination) and 1 month after the last dose | |
Primary | Geometric mean titer (GMT) II | Measure neutralizing antibody titers against Influenza A (H3N2, H1N1) and B Type viruses | Baseline (before vaccination) and 1 month after the last dose | |
Secondary | adverse events following vaccination | analyse the numbers and rates of participants who experience adverse events following immunization | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |