Quadrivalent Influenza Virus VaccinePhase 1NCT02708173

Safety Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged 3 Years and Older

A Phase 1 study testing 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 at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study evaluates the safety of Quadrivalent Influenza Virus Vaccine in Healthy People Aged years 3 to 60.40 Subjects will be equally divided into 2 groups,including 3-17 years old and 18-60 years old.Adult group first receive one dose of Quadrivalent Influenza Virus Vaccine.Then minors group also receive one dose… 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 of Quadrivalent Influenza Virus Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: Mar 2016to Jun 2016
Phase: Phase 1
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 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.
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.

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

China1 site

DongBa clinical center
Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Conditions: Quadrivalent Influenza Virus Vaccine
Being tested: One dose of Quadrivalent Influenza Virus Vaccine
Keywords: vaccine, safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

One dose of Quadrivalent Influenza Virus VaccineBiological
One dose of Quadrivalent Influenza Virus VaccineBiological

Study groups in NCT02708173
Study group	Role	What they receive
One dose Vaccine in aged 18-60 years old	Experimental	One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 18-60 years old. Receives: Biological: One dose of Quadrivalent Influenza Virus Vaccine
One dose Vaccine in aged 3-17 years old	Experimental	One dose of Quadrivalent Influenza Virus Vaccine will be given in aged 3-17 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.

The rate of adverse reactions of Quadrivalent Influenza Virus Vaccine
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: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Jun 2016

First posted15 Mar 2016 (estimated)
Study startMar 2016
Primary completionMar 2016
Study 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 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02708173
Sponsor's protocol ID: cycdc2015-5
Status last verified: Mar 2016
First submitted: 10 Mar 2016
Last updated: 15 Aug 2016
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)

All Quadrivalent Influenza Virus Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Study of Quadrivalent Influenza Virus Vaccine in Healthy People Aged 3 Years and Older
ClinicalTrials.gov ID: NCT02708173
Acronym / sponsor ID: cycdc2015-5
Conditions: Quadrivalent Influenza Virus Vaccine
Keywords: vaccine, safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Beijing Chaoyang District Centre for Disease Control and PreventionUniversity, hospital or other
Study start: Mar 2016
Primary completion: Mar 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 15 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.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
One dose Vaccine in aged 18-60 years old	Experimental	Biological: One dose of Quadrivalent Influenza Virus VaccineOne dose of Quadrivalent Influenza Virus Vaccine will be given in aged 18-60 years old.
One dose Vaccine in aged 3-17 years old	Experimental	Biological: One dose of Quadrivalent Influenza Virus VaccineOne dose of Quadrivalent Influenza Virus Vaccine will be given in aged 3-17 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 (18 listed)

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.
People has congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease)

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 of Quadrivalent Influenza Virus Vaccine	Biological	One dose Vaccine in aged 18-60 years old
One dose of Quadrivalent Influenza Virus Vaccine	Biological	One dose Vaccine in aged 3-17 years old

Primary outcome

The rate of adverse reactions of Quadrivalent Influenza Virus Vaccine
Time frame: 3 months
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

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 15 Aug 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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 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 15 Aug 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 rate of adverse reactions of Quadrivalent Influenza Virus Vaccine (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02708173.

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 15 Aug 2016.