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Pandemic Influenza VaccinePhase 1NCT00660257

Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine

A Phase 1 study testing pandemic influenza vaccine (H5N1 strain NIBRG-14) in people with Pandemic Influenza Vaccine and Prevention, 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, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted). Read more about this study

Who is it for?
Ages 19 to 61 yearsHealthy volunteers can take part
What is being tested?
pandemic influenza vaccine (H5N1 strain NIBRG-14)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteChina
Study dates
Jan 2007to Mar 2008
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 19 to 61 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Had received two-dose priming vaccination in previous phase I trial
  • Be able to show legal identity card for the sake of recruitment
  • Be able to understand and sign the informed consent.

Who cannot join

  • Woman： Who breast-feeding or planning to become pregnant during the study
  • Any history of allergic reactions to vaccines or eggs
  • Autoimmune disease or immunodeficiency
  • Diabetes mellitus (type I or II), with the exception of gestational diabetes
  • Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
  • Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment
Show all 18Show fewer
  • 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
  • Guillain-Barre Syndrome
  • Women subjects with positive urinary pregnancy test
  • Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months
  • History of any blood products administration 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; or 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

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza (H5N1)Vaccine in Two-Dose Primed Healthy Adults: A Single Center, Non-Randomized Clinical Trial

A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).

Being tested
pandemic influenza vaccine (H5N1 strain NIBRG-14)

What participants receive

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

  • pandemic influenza vaccine (H5N1 strain NIBRG-14)Biological

    pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection

  • pandemic influenza vaccine (H5N1 strain NIBRG-14)Biological

    pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection

  • pandemic influenza vaccine (H5N1 strain NIBRG-14)Biological

    pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection

  • pandemic influenza vaccine (H5N1 strain NIBRG-14)Biological

    pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection

Study groups in NCT00660257
Study groupRoleWhat they receive
No.1: 1.25 ugExperimentalNot described
Receives: Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
No.2: 2.5 ugExperimentalNot described
Receives: Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
No.3: 5.0 ugExperimentalNot described
Receives: Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
No. 4: 10 ugExperimentalNot described
Receives: Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)

What is being measured

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

  1. HI antibody Neutralization antibody

    Measured: 15 and 30 days after the booster dose

Secondary outcomes (1)

  1. local adverse reactions systemic adverse reactions temperature

    Measured: 3 days after booster dose

Timeline

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

  1. First posted17 Apr 2008 (estimated)
  2. Study startJan 2007
  3. Primary completionMar 2007
  4. Study completionMar 2008

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 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00660257
Sponsor's protocol ID
PRO-PanFlu-1002
Status last verified
Apr 2008
First submitted
15 Apr 2008
Last updated
17 Apr 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Lin JT, Li CG, Wang X, Su N, Liu Y, Qiu YZ, Yang M, Chen JT, Fang HH, Dong XP, Yin WD, Feng ZJ. Antibody persistence after 2-dose priming and booster response to a third dose of an inactivated, adjuvanted, whole-virion H5N1 vaccine. J Infect Dis. 2009 Jan 15;199(2):184-7. doi: 10.1086/595832.

    PubMed 19067606

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pandemic influenza vaccine (H5N1 strain NIBRG-14) in people with Pandemic Influenza Vaccine and Prevention, 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 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 17 Apr 2008. 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?

HI antibody Neutralization antibody (time frame: 15 and 30 days after the booster dose). 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 NCT00660257, 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 17 Apr 2008.

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