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NCT Number: NCT02710409

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Guanyun County Center for Disease Control and Prevention

Lianyungang, Jiangsu, China

About this study

Subjects will be randomized into three arms- Experimental Group, Active Comparator A and Active Comparator B by the ratio of 2:1:1.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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 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
  • 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

Treatment and study plan

Quadrivalent Influenza Vaccine

Biological

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

Trivalent influenza vaccine A

Biological

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

Trivalent influenza vaccine B

Biological

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

Primary outcomes

  1. 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

    Time frame: 28 days after vaccination

    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.

  2. incidence of solicited adverse reactions after vaccination

    Time frame: 0-7 days after vaccination

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

Secondary outcomes

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

    Time frame: 28 days after vaccination

    A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.

  2. 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

    Time frame: 28 days after vaccination

    Hemagglutination inhibition (HI) titers were used to calculate post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines.

  3. incidence of unsolicited adverse reactions after vaccination

    Time frame: 0-28 days after vaccination

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

  4. incidence of serious adverse event (SAE) after vaccination

    Time frame: 0-28 days after vaccination

  5. incidence of serious adverse event (SAE) after vaccination

    Time frame: 29 days to 6 month after vaccination

Sponsors and collaborators

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention

Network

Collaborators

  • Jiangsu Jindike Biotechnology Co., Ltd.

Registry information

Official study title

A Double-blind,Randomized,Positive-controlled, Non-inferiority Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine (Split Virion) in Healthy Chinese Subjects Aged 3 Years and Older

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 16, 2016
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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