A Phase I Clinical Trial for Inactivated Quadrivalent Influenza Vaccine (Split Virion) in Healthy Adults in China

NCT02269007 | Completed Phase 1

• 1 other identifier: JSVCT019
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Keywords

safety, tolerance, quadrivalent influenza vaccine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• to evaluate incidence of unsolicited adverse reactions (including systemic and local adverse reactions) after vaccination

  0-21 days after vaccination

• to evaluate incidence of serious adverse event (SAE) after vaccination

  0-21 days after vaccination

Study Arms (1)

0.5ml influenza vaccine

EXPERIMENTAL

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

Biological: inactivated quadrivalent influenza vaccine (split virion)

Interventions

inactivated quadrivalent influenza vaccine (split virion) BIOLOGICAL

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

0.5ml influenza vaccine

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Jiangsu Jindike Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Guanyun County Center for Disease Control and Prevention

Liangyungang, Jiangsu, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Fengcai Zhu, Master

  Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 20, 2014
• Study Start: May 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

CN (1)