InfluenzaPhase 4NCT02640989

Safety and Immunogenicity of Three Seasonal Trivalent Influenza Vaccines in China Military

A Phase 4 study testing Seasonal trivalent influenza vaccine, Anflu®, Seasonal trivalent influenza vaccine, VAXIGRIP and Seasonal trivalent influenza vaccine, Fluarix in people with Influenza, run by Center for Disease Prevention and Control of Beijing Military Region 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

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Trial summary

The purpose of this study is to assess the safety and immunogenicity of three seasonal trivalent influenza vaccines (TIVs)manufactured by Glaxosmith Kline (GSK), Beijing Sinovac Biotech (Sinovac) and Shenzhen Sanofi Pasteur (Pasteur) in Chinese healthy servicemen. Read more about this study

Who is it for?: Ages 18 to 34 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Seasonal trivalent influenza vaccine, Anflu®, Seasonal trivalent influenza vaccine, VAXIGRIP and Seasonal trivalent influenza vaccine, Fluarix
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 292 participants
Where: 1 siteChina
Study dates: Oct 2014to Apr 2015
Phase: Phase 4
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 18 to 34 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy servicemen aged between 18-34 years ,who had not received any influenza vaccine during recent three years;
Proven legal identity;
Written informed consent;
Complying with the requirement of the study protocol;

Who cannot join

Pregnant, breast feeding women;
History of allergy to any vaccine or vaccine ingredient;
Receipt of any immunosuppressant within 6 month prior to study entry;
Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, Guillain-Barré syndrome, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor;
Acute disease or acute stage of chronic disease within 7 days prior to study entry;
Axillaty temperature > 37.0 °C;
Any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study;

Trial locations and contacts

1 site in 1 country.

China1 site

Center for Disease Prevention and Control of Beijing Military Region
Beijing, Beijing Municipality, 100042

Other trials in China

About this study

Read the detailed description

This study is a 1:1:1 randomized, double-blinded, controlled phase Ⅳ clinical trial in a military command in Beijing. Healthy individuals aged between 18～34 years who had not received any influenza vaccine during recent three years will be enrolled and administrated one dose TIV. Safety data will be collected for whole study (Day 0 to Day 30).Blood samples will be collected for immunogenicity assessments before injection and 21 days after vaccination.

Conditions: Influenza
Being tested: Seasonal trivalent influenza vaccine, Anflu®, Seasonal trivalent influenza vaccine, VAXIGRIP, Seasonal trivalent influenza vaccine, Fluarix
Keywords: Influenza Vaccine, Safety, Immunogenicity
Medical subject headings: Influenza, Human

What participants receive

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

Seasonal trivalent influenza vaccine, Anflu®Biological
Also called Anflu®
Seasonal trivalent influenza vaccine manufactured by Sinovac Co., Ltd.
Seasonal trivalent influenza vaccine, VAXIGRIPBiological
Also called VAXIGRIP
Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur
Seasonal trivalent influenza vaccine, FluarixBiological
Also called Fluarix
Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals

Study groups in NCT02640989
Study group	Role	What they receive
Group 1	Experimental	* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Seasonal trivalent influenza vaccine, Anflu® Receives: Biological: Seasonal trivalent influenza vaccine, Anflu®
Group 2	Experimental	* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Seasonal trivalent influenza vaccine, VAXIGRIP Receives: Biological: Seasonal trivalent influenza vaccine, VAXIGRIP
Group 3	Active comparator	* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Seasonal trivalent influenza vaccine, Fluarix Receives: Biological: Seasonal trivalent influenza vaccine, Fluarix

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemagglutination inhibition (HI) titers of each strain which were recommended by WHO for the 2014 seasonal influenza vaccines
Hemagglutination inhibition (HI) titers were measured using the antigen and standard serum provided by the National Institute for Biological Standards and Control (NIBSC).
Measured: 21 days after vaccination

Secondary outcomes (4)

The incidences of adverse events (AEs)
After vaccination, occurrences of AEs were collected till day 21. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination).
Measured: 21 days after vaccination
The post-vaccination seroprotection rates of each of the influenza vaccines
Hemagglutination inhibition (HI) titers were used to calculate post-vaccination seroprotection rates of each of the influenza vaccines. By European Committee(European criteria): in adults aged between 18 to 60, post-vaccination seroprotection rates should be ≥ 70% for all vaccine strains.
Measured: 21 days after vaccination
The post-vaccination seroconversion rates of each of the influenza vaccines
Hemagglutination inhibition (HI) titers were used to calculate post-vaccination seroconversion rates of each of the influenza vaccines. By European Committee(European criteria): in adults aged between 18 to 60, post-vaccination seroconversion rates should be > 40% for all vaccine strains.
Measured: 21 days after vaccination
The post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines
Hemagglutination inhibition (HI) titers were used to calculate post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines. By European Committee(European criteria): in adults aged between 18 to 60, post-vaccination mean geometric increases (GMIs) should be ≥ 2.5 for all vaccine strains.
Measured: 21 days after vaccination

Timeline

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

Oct 2014Apr 2015

First posted29 Dec 2015 (estimated)
Study startOct 2014
Primary completionOct 2014
Study completionApr 2015

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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 292 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02640989
Sponsor's protocol ID: PRO-INF-BJJQ-01
Status last verified: Dec 2015
First submitted: 4 Dec 2015
Last updated: 29 Dec 2015
Results posted: No
Data monitoring committee: Yes

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

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Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of Three Seasonal Trivalent Influenza Vaccines in China Military
ClinicalTrials.gov ID: NCT02640989
Acronym / sponsor ID: PRO-INF-BJJQ-01
Conditions: Influenza
Keywords: Influenza Vaccine, Safety, Immunogenicity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 292 participants (actual)
Lead sponsor: Center for Disease Prevention and Control of Beijing Military RegionUniversity, hospital or other
Study start: Oct 2014
Primary completion: Oct 2014 (actual)
Study completion: Apr 2015 (actual)
First posted: 29 Dec 2015 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Group 1	Experimental	Biological: Seasonal trivalent influenza vaccine, Anflu®* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Seasonal trivalent influenza vaccine, Anflu®
Group 2	Experimental	Biological: Seasonal trivalent influenza vaccine, VAXIGRIP* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Seasonal trivalent influenza vaccine, VAXIGRIP
Group 3	Active comparator	Biological: Seasonal trivalent influenza vaccine, Fluarix* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0 * Seasonal trivalent influenza vaccine, Fluarix

Who may qualify

Ages: 18 to 34 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy servicemen aged between 18-34 years ,who had not received any influenza vaccine during recent three years;
Proven legal identity;
Written informed consent;
Complying with the requirement of the study protocol;

Key exclusion criteria (7 listed)

Pregnant, breast feeding women;
History of allergy to any vaccine or vaccine ingredient;
Receipt of any immunosuppressant within 6 month prior to study entry;
Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, Guillain-Barré syndrome, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor;
Acute disease or acute stage of chronic disease within 7 days prior to study entry;

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
Seasonal trivalent influenza vaccine, Anflu®Also: Anflu®Seasonal trivalent influenza vaccine manufactured by Sinovac Co., Ltd.	Biological	Group 1
Seasonal trivalent influenza vaccine, VAXIGRIPAlso: VAXIGRIPSeasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur	Biological	Group 2
Seasonal trivalent influenza vaccine, FluarixAlso: FluarixSeasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals	Biological	Group 3

Primary outcome

Hemagglutination inhibition (HI) titers of each strain which were recommended by WHO for the 2014 seasonal influenza vaccines
Time frame: 21 days after vaccination
Hemagglutination inhibition (HI) titers were measured using the antigen and standard serum provided by the National Institute for Biological Standards and Control (NIBSC).

4 secondary outcomes

The incidences of adverse events (AEs)
Time frame: 21 days after vaccination
The post-vaccination seroprotection rates of each of the influenza vaccines
Time frame: 21 days after vaccination
The post-vaccination seroconversion rates of each of the influenza vaccines
Time frame: 21 days after vaccination
The post-vaccination mean geometric increases (GMIs) of each of the influenza vaccines
Time frame: 21 days 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 29 Dec 2015.

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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.

Dongqi Gao, PhD principal investigator

Center for Disease Prevention and Control of Beijing Military Region

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 4 inclusion and 7 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 29 Dec 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Hemagglutination inhibition (HI) titers of each strain which were recommended by WHO for the 2014 seasonal influenza vaccines (time frame: 21 days after vaccination). 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 NCT02640989.

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 29 Dec 2015.