A Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine in Healthy Subjects Aged 3 Years and Older

NCT02710409 | Completed Phase 3

• 1 other identifier: JSVCT031
• Study Type: interventional
• Target: 3,664
• 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. 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. In order to evaluate safety and immunogenicity of a quadrivalent influenza vaccine produced by Jiangsu Jindike Biotechnology Co., Ltd. a phase III clinical trial is planned to conduct in healthy Chinese subjects aged 3 years and older.

Conditions

Influenza

Keywords

safety, immunogenicity , quadrivalent influenza vaccine

Outcome Measures

Primary Outcomes (2)

• the 95% confidence interval (CI) lower limit for the seroconversion against each corresponding flu strain after vaccination is≥40% in subjects aged 3-59 years and≥30% in subjects aged ≥60 years separately

  Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer \< 1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.

  28 days after vaccination

• incidence of solicited adverse reactions after vaccination

  incidence of solicited adverse reactions (including systemic and local adverse reactions) after vaccination

  0-7 days after vaccination

Secondary Outcomes (5)

• the 95% CI lower limit for the post-vaccination seroprotection rates against each corresponding flu strain is ≥70%

  28 days after vaccination

• the post-vaccination mean geometric increases (GMIs) of HAI titer against each corresponding flu strain is≥2.5 in subjects aged 3-59 years and≥2.0 in subjects aged ≥60 years separately

  28 days after vaccination

• incidence of unsolicited adverse reactions after vaccination

  0-28 days after vaccination

• incidence of serious adverse event (SAE) after vaccination

  0-28 days after vaccination

• incidence of serious adverse event (SAE) after vaccination

  29 days to 6 month after vaccination

Study Arms (3)

Quadrivalent influenza vaccine

EXPERIMENTAL

Biological: Quadrivalent influenza vaccine

Trivalent influenza vaccine A

ACTIVE COMPARATOR

Active Comparator A

Biological: Trivalent influenza vaccine A

Trivalent influenza vaccine B

ACTIVE COMPARATOR

Active Comparator B

Biological: Trivalent influenza vaccine B

Interventions

Quadrivalent influenza vaccine BIOLOGICAL

0.5 ml/vial, one dose, intramuscular injection on day 0

Quadrivalent influenza vaccine

Trivalent influenza vaccine A BIOLOGICAL

0.5 ml/vial, one dose, intramuscular injection on day 0

Trivalent influenza vaccine A

Trivalent influenza vaccine B BIOLOGICAL

0.5 ml/vial, one dose, intramuscular injection on day 0

Trivalent influenza vaccine B

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 3 years and older
• Healthy subjects judged from medical history and clinical examination
• Subjects themselves or their guardians able to understand and sign the informed consent
• Subjects themselves or their guardians 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 aged ≥18 years 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
• 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

Lianyungang, Jiangsu, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2016
• First Posted: March 16, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

CN (1)