InfluenzaPhase 4NCT02269852
The Immunogenicity and Safety of 2013-2014 Seasonal Trivalent Influenza Vaccine
A Phase 4 study testing trivalent seasonal influenza vaccine in people with Influenza, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged > 60 years. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- trivalent seasonal influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Jun 2014
- 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy adults aged 18-60 years old, and healthy seniors aged > 60 years old;
- Without vaccination history of seasonal split influenza vaccine in the recent 3 years
- No traveling plan during the study period of this trial;
- Be able to understand and sign the informed consent;
- Healthy male or female aged between 6 and 35 months;
- Full-term birth, birth weight 2,500 grams or more;
- Provided birth certification or vaccination card
- Parent or legal guardian is able to understand and sign the informed consent;
Who cannot join
- Allergic to egg products or any ingredient of the study vaccine;
- Fever, influenza or acute illness on the vaccination day;
- Acute stage of chronic illness;
- Malignant tumor;
- Immunodeficiency, includes HIV infection;
- Guillain-Barre syndrome;
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- Administration of live attenuated vaccine within the previous 14 days;
- Administration of subunit or inactivated vaccine within the previous 7 days;
- Planned to participate in any other clinical trial of drug or vaccine during this study;
- Received immunesuppressive treatment within the previous month, or planned for such treatment during this study;
- Pregnant, or planning pregnancy;
- Axillary temperature > 37.0℃;
- Any other factors that, in the judgment of the investigator, is unsuitable for this study;
- For infants:
- Received seasonal influenza vaccine after June 30, 2012;
- Acute infection within the previous week;
- Allergy history, or allergic to any ingredient of the study vaccine, such as egg;
- History of serious adverse reaction (SAR) to vaccine;
- Autoimmune disease or immune deficiency, or administration of immunosuppressive therapy, cell toxic therapy, or inhaled corticosteroid within the previous 6 months;
- Congenital malformations, developmental disorder or serious chronic disease;
- Unstable condition of asthma and administration of corticosteroid in the most recent two years;
- Coagulation abnormalities or disorders;
- History/ family history of infantile convulsion, epilepsy, cerebropathy, or mental disease;
- Without spleen;
- Severe neurological diseases, such as Guillain-Barre syndrome;
- Administration of blood products or investigational drug within the previous month;
- Administration of live attenuated vaccine within the previous 14 days;
- Administration of subunit or inactivated vaccine within the previous 7 days;
- Received treatment for allergy within the previous 14 days;
- on-going anti-tuberculosis therapy;
- Axillary temperature > 37.0℃ immediately before vaccination;
- any other factors that, in the judgment of the investigator, is unsuitable for this study;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centered, Open-labeled, Phase 4 Study of a Northern Hemisphere 2013-2014 Seasonal Trivalent Influenza Inactivated Vaccine, Anflu®
The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged > 60 years.
- Conditions
- Influenza
- Being tested
- trivalent seasonal influenza vaccine
- Keywords
- seasonal trivalent inactivated influenza vaccine, immunogenicity, safety, cross-reactivity, Northern hemisphere 2013-2014 formulation
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trivalent seasonal influenza vaccineBiological
Also called Anflu®
- Infants: 0.25 ml/ dose;
- Adults: 0.5 ml/ dose;
- Seniors: 0.5 ml/ dose;
| Study group | Role | What they receive |
|---|---|---|
| trivalent seasonal influenza vaccine | Experimental | Northern hemisphere 2013-2014 trivalent seasonal influenza vaccine
* 60 infants: two-dose regimen with a 28-day interval;
* 60 adults: single-dose regimen;
* 60 seniors: single-dose regimen; Receives: Biological: trivalent seasonal influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors
To evaluate the immune responses to each antigen of the 2013-2014 seasonal TIV in adults and seniors by detection of hemagglutination inhibition (HI) antibody titer
Measured: 21 days after vaccination
Secondary outcomes (2)
The incidences of adverse events (AEs) in infants, adults and seniors
After each injection, a 30-minute safety observation was conducted immediately, and the body temperature, occurrence of solicited local and general AEs within 72 hours were collected. Unsolicited AEs of adults and seniors were collected until day 21, and those of infants were collected until day 35. Each AE case was reviewed by the investigator to determine whether or not it was an adverse reaction (related to the vaccination).
Measured: Day 0 - day 35
The cross-reactivity of 2013-2014 seasonal TIV in adults and seniors against influenza B Victoria lineage virus and the avian influenza A(H7N9) virus
To evaluate the cross-reactivity of 2013-2014 seasonal TIV in adults and seniors against influenza B Victoria lineage virus (not in the vaccine formulation) and the avian influenza A(H7N9) virus by detection of HI antibody titer
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.
- First posted21 Oct 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yong-Gang Shen, Principal investigator, Anhui Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269852
- Sponsor's protocol ID
- PRO-INF-4013
- Status last verified
- Sep 2015
- First submitted
- 8 Oct 2014
- Last updated
- 21 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shen Y, Hu Y, Meng F, Du W, Li W, Song Y, Ji X, Huo L, Fu Z, Yin W. Safety, immunogenicity and cross-reactivity of a Northern hemisphere 2013-2014 seasonal trivalent inactivated split influenza virus vaccine, Anflu(R). Hum Vaccin Immunother. 2016 May 3;12(5):1229-34. doi: 10.1080/21645515.2015.1123357. Epub 2016 Mar 2.
PubMed 26934750
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centered, Open-labeled, Phase 4 Study of a Northern Hemisphere 2013-2014 Seasonal Trivalent Influenza Inactivated Vaccine, Anflu®
- ClinicalTrials.gov ID
- NCT02269852
- Acronym / sponsor ID
- PRO-INF-4013
- Conditions
- Influenza
- Keywords
- seasonal trivalent inactivated influenza vaccine, immunogenicity, safety, cross-reactivity, Northern hemisphere 2013-2014 formulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Oct 2014 (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.
The purpose of this study is to evaluate the immunogenicity and safety of Northern hemisphere 2013-2014 seasonal trivalent inactivated influenza vaccine in 60 healthy infants aged 6-35 months old, 60 healthy adults aged 18-60 years old, and 60 healthy seniors aged > 60 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trivalent seasonal influenza vaccine | Experimental | Biological: trivalent seasonal influenza vaccineNorthern hemisphere 2013-2014 trivalent seasonal influenza vaccine * 60 infants: two-dose regimen with a 28-day interval; * 60 adults: single-dose regimen; * 60 seniors: single-dose regimen; |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy adults aged 18-60 years old, and healthy seniors aged > 60 years old;
- Without vaccination history of seasonal split influenza vaccine in the recent 3 years
- No traveling plan during the study period of this trial;
- Be able to understand and sign the informed consent;
- Healthy male or female aged between 6 and 35 months;
Key exclusion criteria (32 listed)
- Allergic to egg products or any ingredient of the study vaccine;
- Fever, influenza or acute illness on the vaccination day;
- Acute stage of chronic illness;
- Malignant tumor;
- Immunodeficiency, includes HIV infection;
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 |
|---|---|---|
| trivalent seasonal influenza vaccineAlso: Anflu®* Infants: 0.25 ml/ dose; * Adults: 0.5 ml/ dose; * Seniors: 0.5 ml/ dose; | Biological | trivalent seasonal influenza vaccine |
Primary outcome
The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors
Time frame: 21 days after vaccination
To evaluate the immune responses to each antigen of the 2013-2014 seasonal TIV in adults and seniors by detection of hemagglutination inhibition (HI) antibody titer
2 secondary outcomes
The incidences of adverse events (AEs) in infants, adults and seniors
Time frame: Day 0 - day 35
The cross-reactivity of 2013-2014 seasonal TIV in adults and seniors against influenza B Victoria lineage virus and the avian influenza A(H7N9) virus
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 21 Sep 2015.
- Derived from this study: PubMed 26934750Shen Y, Hu Y, Meng F, Du W, Li W, Song Y, Ji X, Huo L, Fu Z, Yin W. Safety, immunogenicity and cross-reactivity of a Northern hemisphere 2013-2014 seasonal trivalent inactivated split influenza virus vaccine, Anflu(R). Hum Vaccin Immunother. 2016 May 3;12(5):1229-34. doi: 10.1080/21645515.2015.1123357. Epub 2016 Mar 2.
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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.
Yong-Gang Shen principal investigator
Anhui Center for Diseases Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing trivalent seasonal influenza vaccine in people with Influenza, run by Sinovac Biotech Co., Ltd 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 8 inclusion and 32 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 21 Sep 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?
The immunogenicity of 2013-2014 seasonal trivalent vaccine (TIV) in adults and seniors (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 NCT02269852, which also lists 1 linked publication.
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 Sep 2015.