Quadrivalent Influenza Virus VaccinePhase 3NCT02806804
Safety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60
A Phase 3 study testing one dose test vaccine, one dose commercially available trivalent influenza vaccine and One dose of Quadrivalent Influenza Virus Vaccine in people with Quadrivalent Influenza Virus Vaccine, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
Trial summary
This study evaluates the safety and immunogenicity of the quadrivalent influenza virus vaccine in healthy people aged years 3-60.Subjects will be randomly divided into 3 groups,receiving the test vaccine, commercially available trivalent influenza vaccine and trivalent influenza vaccine containing new influenza B… Read more about this study
- Who is it for?
- Ages 3 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Quadrivalent Influenza Virus Vaccine
- What is being tested?
- one dose test vaccine, one dose commercially available trivalent influenza vaccine and One dose of Quadrivalent Influenza Virus Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jun 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy subjects more than 3 years old, and the subjects can be informed consent, and sign the informed consent.
- the subjects and his guardians can obey the demands of the scheme .
- Axillary temperature less than 37℃
Who cannot join
- The people who has flu or influenza-like symptoms(fever <axillary temperature ≥38 ℃>, cough or sore throat) within 3 months
- The people who has vaccinated influenza vaccine in 3years.
- The people who has a vaccine allergies, or who allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc.
- The people who has serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
- the subject who has symptoms of acute infection within a week.
- Autoimmune diseases or Immune function defect, people has immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months.
Show all 20Show fewer
- People has congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease)
- People has asthma Unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years.
- Diagnosed abnormal coagulation(Lack of clotting factors,Clotting disorders,Platelet abnormality) or significant bruising or coagulopathy
- people has history or family history of convulsions, seizures, encephalopathy and psychiatric.
- alienia, functional asplenia, and alienia or splenectomy in any situation.
- Serious neurological disorders such as Green Barry syndrome.
- people who has received blood products or immunoglobulin products in the past one months.
- people who has received other study drug in the past one month.
- people who received live attenuated vaccine, subunit vaccine or inactivated vaccine.
- people who has received allergy treatment in in the past 14 days.
- People who is on anti-TB treatment.
- People whose axillary temperature is more than 37℃ before the vaccination.
- People who is pregnant.
- Any factors unsuitable for clinical trail according to the researchers.
About this study
This study evaluates the safety and immunogenicity of the quadrivalent influenza virus vaccine in healthy people aged years 3-60.Subjects will be randomly divided into 3 groups,receiving the test vaccine, commercially available trivalent influenza vaccine and trivalent influenza vaccine containing new influenza B component respectively. Each group has 800 subjects,2400 in total.
- Conditions
- Quadrivalent Influenza Virus Vaccine
- Being tested
- one dose test vaccine, one dose commercially available trivalent influenza vaccine, One dose of Quadrivalent Influenza Virus Vaccine
- Keywords
- vaccine, safety, immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one dose test vaccineBiological
one dose commercially available trivalent influenza vaccineBiological
One dose of Quadrivalent Influenza Virus VaccineBiological
| Study group | Role | What they receive |
|---|---|---|
| one dose test vaccine | Experimental | One dose of quadrivalent influenza virus vaccine will be randomly given in aged 3-60 years old. Receives: Biological: one dose test vaccine |
| one dose commercially available trivalent influenza vaccine | Experimental | One dose of trivalent influenza virus vaccine will be randomly given in aged 3-60 years old. Receives: Biological: one dose commercially available trivalent influenza vaccine |
| One dose quadrivalent influenza virus vaccine | Experimental | One dose of quadrivalent influenza virus vaccine (trivalent influenza virus vaccine added to a new influenza B component) will be randomly given in aged 3-60 years old. Receives: Biological: One dose of Quadrivalent Influenza Virus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
The serum antibody titers will be evaluated at 28 days after vaccination.
Measured: 28 days
Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.
Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadrivalent Influenza Virus VaccineStudies 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and Prevention
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806804
- Sponsor's protocol ID
- cycdc2016-1
- Status last verified
- Jun 2016
- First submitted
- 15 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged Years 3-60
- ClinicalTrials.gov ID
- NCT02806804
- Acronym / sponsor ID
- cycdc2016-1
- Conditions
- Quadrivalent Influenza Virus Vaccine
- Keywords
- vaccine, safety, immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Beijing Chaoyang District Centre for Disease Control and PreventionUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2016 (actual)
- First posted
- 21 Jun 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.
This study evaluates the safety and immunogenicity of the quadrivalent influenza virus vaccine in healthy people aged years 3-60.Subjects will be randomly divided into 3 groups,receiving the test vaccine, commercially available trivalent influenza vaccine and trivalent influenza vaccine containing new influenza B component respectively. Each group has 800 subjects,2400 in total.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| one dose test vaccine | Experimental | Biological: one dose test vaccineOne dose of quadrivalent influenza virus vaccine will be randomly given in aged 3-60 years old. |
| one dose commercially available trivalent influenza vaccine | Experimental | Biological: one dose commercially available trivalent influenza vaccineOne dose of trivalent influenza virus vaccine will be randomly given in aged 3-60 years old. |
| One dose quadrivalent influenza virus vaccine | Experimental | Biological: One dose of Quadrivalent Influenza Virus VaccineOne dose of quadrivalent influenza virus vaccine (trivalent influenza virus vaccine added to a new influenza B component) will be randomly given in aged 3-60 years old. |
Who may qualify
- Ages
- 3 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- healthy subjects more than 3 years old, and the subjects can be informed consent, and sign the informed consent.
- the subjects and his guardians can obey the demands of the scheme .
- Axillary temperature less than 37℃
Key exclusion criteria (20 listed)
- The people who has flu or influenza-like symptoms(fever <axillary temperature ≥38 ℃>, cough or sore throat) within 3 months
- The people who has vaccinated influenza vaccine in 3years.
- The people who has a vaccine allergies, or who allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc.
- The people who has serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain.
- the subject who has symptoms of acute infection within a week.
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 |
|---|---|---|
| one dose test vaccine | Biological | one dose test vaccine |
| one dose commercially available trivalent influenza vaccine | Biological | one dose commercially available trivalent influenza vaccine |
| One dose of Quadrivalent Influenza Virus Vaccine | Biological | One dose quadrivalent influenza virus vaccine |
Primary outcome
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people.
Time frame: 28 days
The serum antibody titers will be evaluated at 28 days after vaccination.
Evaluate the Rate of Adverse reactions of quadrivalent influenza Vaccine in healthy people.
Time frame: 28 days
Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
Related trials for Quadrivalent Influenza Virus Vaccine
Not yet recruitingPhase 4
Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer
Pneumococcal Polysaccharide Vaccine, Influenza Vaccines
RecruitingPhase 1
Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults
Influenza Prevention, Pandemic Influenza Prevention
RecruitingPhase 1/2
Clinical Trials of Quadrivalent Influenza Vaccine
Influenza, Human
Active, not recruitingPhase 1
Clinical Trial of Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older
Influenza, Influenza Vaccine
Not yet recruitingObservational study
Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.
Immunization, Influenza (Healthy Volunteers)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing one dose test vaccine, one dose commercially available trivalent influenza vaccine and One dose of Quadrivalent Influenza Virus Vaccine in people with Quadrivalent Influenza Virus Vaccine, run by Beijing Chaoyang District Centre for Disease Control and Prevention.
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 3 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Evaluate serum antibody titers of quadrivalent influenza Vaccine in healthy people. (time frame: 28 days). 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 21 Jun 2016.