InfluenzaPhase 3NCT02710409
A Phase III Clinical Trial of An Inactivated Quadrivalent Influenza Vaccine in Healthy Subjects Aged 3 Years and Older
A Phase 3 study testing Quadrivalent influenza vaccine, Trivalent influenza vaccine A and Trivalent influenza vaccine B in people with Influenza, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Quadrivalent influenza vaccine, Trivalent influenza vaccine A and Trivalent influenza vaccine B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,664 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Aug 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Guanyun County Center for Disease Control and Prevention
Lianyungang, Jiangsu
About this study
Official 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
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.
Read the detailed description
Subjects will be randomized into three arms- Experimental Group, Active Comparator A and Active Comparator B by the ratio of 2:1:1.
- Conditions
- Influenza
- Being tested
- Quadrivalent influenza vaccine, Trivalent influenza vaccine A, Trivalent influenza vaccine B
- Keywords
- safety, immunogenicity , quadrivalent influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent influenza vaccineBiological
0.5 ml/vial, one dose, intramuscular injection on day 0
Trivalent influenza vaccine ABiological
0.5 ml/vial, one dose, intramuscular injection on day 0
Trivalent influenza vaccine BBiological
0.5 ml/vial, one dose, intramuscular injection on day 0
| Study group | Role | What they receive |
|---|---|---|
| Quadrivalent influenza vaccine | Experimental | Not described Receives: Biological: Quadrivalent influenza vaccine |
| Trivalent influenza vaccine A | Active comparator | Active Comparator A Receives: Biological: Trivalent influenza vaccine A |
| Trivalent influenza vaccine B | Active comparator | Active Comparator B Receives: Biological: Trivalent influenza vaccine B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after vaccination
incidence of solicited adverse reactions after vaccination
incidence of solicited adverse reactions (including systemic and local adverse reactions) after vaccination
Measured: 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%
A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.
Measured: 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
Hemagglutination inhibition (HI) titers were used to calculate post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines.
Measured: 28 days after vaccination
incidence of unsolicited adverse reactions after vaccination
incidence of unsolicited adverse reactions (including systemic and local adverse reactions) after vaccination
Measured: 0-28 days after vaccination
incidence of serious adverse event (SAE) after vaccination
Measured: 0-28 days after vaccination
incidence of serious adverse event (SAE) after vaccination
Measured: 29 days to 6 month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3,664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Jiangsu Jindike Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710409
- Sponsor's protocol ID
- JSVCT031
- Status last verified
- Aug 2016
- First submitted
- 12 Mar 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02710409
- Acronym / sponsor ID
- JSVCT031
- Conditions
- Influenza
- Keywords
- safety, immunogenicity , quadrivalent influenza vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,664 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Jiangsu Jindike Biotechnology Co., Ltd.
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will be randomized into three arms- Experimental Group, Active Comparator A and Active Comparator B by the ratio of 2:1:1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quadrivalent influenza vaccine | Experimental | Biological: Quadrivalent influenza vaccine |
| Trivalent influenza vaccine A | Active comparator | Biological: Trivalent influenza vaccine AActive Comparator A |
| Trivalent influenza vaccine B | Active comparator | Biological: Trivalent influenza vaccine BActive Comparator B |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrivalent influenza vaccine0.5 ml/vial, one dose, intramuscular injection on day 0 | Biological | Quadrivalent influenza vaccine |
| Trivalent influenza vaccine A0.5 ml/vial, one dose, intramuscular injection on day 0 | Biological | Trivalent influenza vaccine A |
| Trivalent influenza vaccine B0.5 ml/vial, one dose, intramuscular injection on day 0 | Biological | Trivalent influenza vaccine B |
Primary outcome
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.
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
5 secondary outcomes
the 95% CI lower limit for the post-vaccination seroprotection rates against each corresponding flu strain is ≥70%
Time frame: 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
Time frame: 28 days after vaccination
incidence of unsolicited adverse reactions after vaccination
Time frame: 0-28 days after vaccination
incidence of serious adverse event (SAE) after vaccination
Time frame: 0-28 days after vaccination
incidence of serious adverse event (SAE) after vaccination
Time frame: 29 days to 6 month after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quadrivalent influenza vaccine, Trivalent influenza vaccine A and Trivalent influenza vaccine B in people with Influenza, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2016.