Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02269007
Other study ID # JSVCT019
Secondary ID
Status Completed
Phase Phase 1
First received October 16, 2014
Last updated October 11, 2015
Start date May 2015
Est. completion date September 2015

Study information

Verified date October 2015
Source Jiangsu Province Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Influenza is an acute respiratory disease caused by influenza viruses. There are three types of the virus including A, B and C. Both type A and type B viruses can cause acute febrile respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough, sore throat, nasal congestion and general malaise.

Influenza can periodically cause worldwide pandemic. For nearly a century, the influenza virus had occurred four large variation, causing three world pandemic. Studies have shown that since 1957, most of those new variants of influenza virus started in China, which is recognized by the world to have high incidence of influenza. At present, trivalent influenza vaccines are widely used in China. They only contain two kinds of type A virus antigens and one type B virus antigen. But since 2000, two kinds of type B strains (Victoria and Yamagata) have caused an alternating cycle in different seasons. Gradually, evolved from the original single lineage of influenza B virus B/Yamagata, two distinct antigenic lineages-B/Victoria and B/Yamagata have alternately dominated or caused a mix of popular lineage. These two lineages have little or nearly no cross-protection. Therefore, trivalent influenza vaccines may not cover the popular strains of influenza B virus, whereas quadrivalent influenza vaccines will help to simultaneously prevent two kinds of type A viruses and two kinds of type B virus.


Description:

Influenza is an acute respiratory disease caused by influenza viruses. There are three types of the virus including A, B and C. Both type A and type B viruses can cause acute febrile respiratory tract infection, characterized by sudden fever, headache, muscle pain, cough, sore throat, nasal congestion and general malaise. The main transmission of influenza is through those highly contagious aerosol droplets containing influenza virus passed from infected people to susceptible population. Each year in the fall and winter infection of influenza is widespread in various age groups, with high incidence rate. Although influenza is generally a self-limiting disease, but in children, the elderly (especially those above 65 years old and those with chronic heart, lung, kidney, liver, blood or metabolic diseases such as diabetes or other certain diseases) and those with poor immunity function, influenza can easily lead to serious flu complications such as pneumonia, resulting in severe increase of morbidity and mortality.

Influenza can periodically cause worldwide pandemic. For nearly a century, the influenza virus had occurred four large variation, causing three world pandemic. Studies have shown that since 1957, most of those new variants of influenza virus started in China, which is recognized by the world to have high incidence of influenza. At present, trivalent influenza vaccines are widely used in China. They only contain two kinds of type A virus antigens and one type B virus antigen. But since 2000, two kinds of type B strains (Victoria and Yamagata) have caused an alternating cycle in different seasons. Gradually, evolved from the original single lineage of influenza B virus B/Yamagata, two distinct antigenic lineages-B/Victoria and B/Yamagata have alternately dominated or caused a mix of popular lineage. These two lineages have little or nearly no cross-protection. Therefore, trivalent influenza vaccines may not cover the popular strains of influenza B virus, whereas quadrivalent influenza vaccines will help to simultaneously prevent two kinds of type A viruses and two kinds of type B virus.

In order to evaluate safety and tolerance of the quadrivalent influenza vaccine produced by Jiangsu Jindike Biotechnology Co., Ltd. a phase I clinical trial is planned to conduct in healthy adults aged from 18 to 49 years in China.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date September 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria:

- Aged from 18 to 49 years old

- Healthy adults judged from medical history and clinical examination

- Subjects able to understand and sign the informed consent

- Subjects who can and will comply with the requirements of the protocol

- Subjects with temperature <=37.0°C on axillary setting

Exclusion Criteria:

- Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease

- Any prior administration of influenza vaccine in last 6 month

- Subject who is allergic to any ingredient of the vaccine

- Female subject with a positive result after urine pregnancy test or during pregnancy or baby nursing period

- Subject with damaged or low immune function which has already been known

- Subject who had a seasonal influenza medical history in last 6 months

- Subject with acute febrile illness or infectious disease

- Major congenital defects or serious chronic illness, including perinatal brain damage

- Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection

- Subject who has serious allergic history

- Subject with other medical history not suitable for vaccination such as fainting during injection or acupuncture treatment

- Any prior administration of immunodepressant or corticosteroids in last 6 months

- Any prior administration of blood products in last 3 months

- Any prior administration of other research medicine/vaccine in last 30 days

- Any prior administration of any attenuated live vaccine in last 30 days

- Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine

- Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
inactivated quadrivalent influenza vaccine (split virion)
0.5ml inactivated quadrivalent influenza vaccine (split virion) for each subject, one dose

Locations

Country Name City State
China Guanyun County Center for Disease Control and Prevention Liangyungang Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
Jiangsu Province Centers for Disease Control and Prevention Jiangsu Jindike Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary to evaluate incidence of solicited adverse reactions (including systemic and local adverse reactions) after vaccination to evaluate incidence of solicited adverse reactions (including systemic and local adverse reactions) within 0-7 days after vaccination 0-7 days after vaccination Yes
Secondary to evaluate incidence of unsolicited adverse reactions (including systemic and local adverse reactions) after vaccination to evaluate incidence of unsolicited adverse reactions (including systemic and local adverse reactions) within 0-21 days after vaccination 0-21 days after vaccination Yes
Secondary to evaluate incidence of serious adverse event (SAE) after vaccination to evaluate incidence of serious adverse event (SAE) within 0-21 days after vaccination 0-21 days after vaccination Yes
See also
  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 NCT03888989 - Response to Influenza Vaccine During Pregnancy Phase 1
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 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