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InfluenzaPhase 4NCT01008137

Sinovac, H1N1 Vaccine + Trivalent Inactivated Influenza Vaccine, Adults

A Phase 4 study testing H1N1 influenza A Vaccine (PANFLU.1) and Trivalent Inactivated Influenza Vaccine (ANFLU) in people with Influenza, run by Sinovac Biotech Co., Ltd 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

A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years) to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's H1N1 influenza A Vaccine (PANFLU.1) with Trivalent Inactivated Influenza Vaccine (ANFLU). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
H1N1 influenza A Vaccine (PANFLU.1) and Trivalent Inactivated Influenza Vaccine (ANFLU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
Oct 2009to Jan 2010
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male or female aged between 18 and 60
  • Be able to show legal identity card for the sake of recruitment
  • Volunteers are able to understand and sign the informed consent

Who cannot join

  • Cases, cured cases and close contact of influenza A (H1N1) virus
  • History of H1N1 vaccine or seasonal influenza vaccine administration
  • Women of pregnancy, lactation or about to be pregnant in 60 days
  • Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
  • Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  • Autoimmune disease or immunodeficiency
Show all 31Show fewer
  • Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
  • Diabetes mellitus (type I or II), with the exception of gestational diabetes
  • History of thyroidectomy or thyroid disease that required medication within the past 12 months
  • Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
  • Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
  • Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
  • Seizure disorder other than:
  • Febrile seizures under the age of two years old
  • Seizures secondary to alcohol withdrawal more than 3 years ago, or
  • A singular seizure not requiring treatment within the last 3 years
  • Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
  • Guillain-Barre Syndrome
  • Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
  • History of any blood products within 3 months before the dosing
  • Administration of any other investigational research agents within 30 days before the dosing
  • Administration of any live attenuated vaccine within 30 days before the dosing
  • Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
  • Be receiving anti-TB prophylaxis or therapy currently
  • Axillary temperature > 37.0 centigrade at the time of dosing
  • Psychiatric condition that precludes compliance with the protocol:
  • Past or present psychoses
  • Past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years
  • Disorder requiring lithium
  • Suicidal ideation occurring within five years prior to enrollment
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Centers for Diseases Control and Prevention

    Beijing

Other trials in China

About this study

Official title: Cell-mediated Immunity Study of H1N1 Influenza A Vaccine With Trivalent Inactivated Influenza Vaccine in Healthy Adults

A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years) to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's H1N1 influenza A Vaccine (PANFLU.1) with Trivalent Inactivated Influenza Vaccine (ANFLU).

Conditions
Influenza
Being tested
H1N1 influenza A Vaccine (PANFLU.1), Trivalent Inactivated Influenza Vaccine (ANFLU)
Medical subject headings
Influenza, Human

What participants receive

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

  • H1N1 influenza A Vaccine (PANFLU.1)Biological

    H1N1 influenza A Vaccine (PANFLU.1), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm)

  • Trivalent Inactivated Influenza Vaccine (ANFLU)Biological

    Trivalent Inactivated Influenza Vaccine (ANFLU), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (injected in the other arm)

Study groups in NCT01008137
Study groupRoleWhat they receive
Group 1: Day 0-PANFLU.1; Day 21-ANFLUExperimental50 subjects to receive-Day 0: 15 μg PANFLU.1 vaccine; Day 21: 15 μg ANFLU vaccine.
Receives: Biological: H1N1 influenza A Vaccine (PANFLU.1); Biological: Trivalent Inactivated Influenza Vaccine (ANFLU)
Group 2: Day 0-ANFLU; Day 21-PANFLU.1Experimental50 subjects to receive-Day 0: 15 μg ANFLU vaccine; Day 21: 15 μg PANFLU.1 vaccine.
Receives: Biological: H1N1 influenza A Vaccine (PANFLU.1); Biological: Trivalent Inactivated Influenza Vaccine (ANFLU)
Group 3: Day 0-PANFLU.1+ANFLUExperimental50 subjects to receive-Day 0: 15 μg PANFLU.1 vaccine+ANFLU vaccine.
Receives: Biological: H1N1 influenza A Vaccine (PANFLU.1); Biological: Trivalent Inactivated Influenza Vaccine (ANFLU)

What is being measured

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

  1. Study the cell-mediated immunity of H1N1 vaccine with seasonal influenza vaccine

    Measured: 6 months

Secondary outcomes (2)

  1. Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in adults

    Measured: 3 months

  2. Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in adults

    Measured: 3 months

Timeline

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

  1. First posted5 Nov 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionDec 2009
  4. Study completionJan 2010

Resources

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
Single blind
Who is masked
Care provider
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01008137
Sponsor's protocol ID
PRO-PanFlu-4002
Status last verified
Nov 2012
First submitted
29 Oct 2009
Last updated
27 Nov 2012
Results posted
No

Publications

  • Wu J, Zhong X, Li CK, Zhou JF, Lu M, Huang KY, Dong M, Liu Y, Luo FJ, Du N, Chui C, Liu LQ, Smith NM, Li B, Shi NM, Song LF, Gao Y, Wang DY, Wang X, Zhu WF, Yan Y, Li Z, Chen JT, McMichael AJ, Yin WD, Xu XN, Shu Y. Optimal vaccination strategies for 2009 pandemic H1N1 and seasonal influenza vaccines in humans. Vaccine. 2011 Jan 29;29(5):1009-16. doi: 10.1016/j.vaccine.2010.11.058. Epub 2010 Dec 2.

    PubMed 21130194

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing H1N1 influenza A Vaccine (PANFLU.1) and Trivalent Inactivated Influenza Vaccine (ANFLU) 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 3 inclusion and 31 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 27 Nov 2012. 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?

Study the cell-mediated immunity of H1N1 vaccine with seasonal influenza vaccine (time frame: 6 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 NCT01008137, 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 27 Nov 2012.

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