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InfluenzaPhase 4NCT03344029

Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Chinese Subjects 18 to 59 Years

A Phase 4 study testing SP Shz TIV and Hualan TIV in people with Influenza and Flu, run by Sanofi 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

This was a blind-observer, monocenter, randomized, comparative, Phase IV study designed to evaluate the immunogenicity and safety of the Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine (SP Shz TIV) versus the Trivalent Influenza Vaccine manufactured by Hualan Biological Engineering Inc (Hualan TIV) comparator in… Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Flu
What is being tested?
SP Shz TIV and Hualan TIV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
1 siteChina
Study dates
3 Nov 2017to 22 May 2018
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 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged ≥ 18 to 59 years on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures

Who cannot join

  • Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non- childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile
  • Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine or planned receipt of any vaccine within the period from 2 weeks before trial vaccination to 2 weeks following trial vaccination
  • Previous vaccination against influenza (in the previous 6 months) with either the trial vaccines or another vaccine
  • Receipt of immune globulins, blood or blood-derived product in the past 3 months
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
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  • Known systemic hypersensitivity to any of the vaccines components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
  • Self-reported thrombocytopenia contraindicating intramuscular vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sanofi Pasteur Investigational Site 001

    Huai'an, 223300

Other trials in China

About this study

Official title: Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Healthy Chinese Subjects Aged 18 to 59 Years

This was a blind-observer, monocenter, randomized, comparative, Phase IV study designed to evaluate the immunogenicity and safety of the Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine (SP Shz TIV) versus the Trivalent Influenza Vaccine manufactured by Hualan Biological Engineering Inc (Hualan TIV) comparator in healthy Chinese participants aged 18 to 59 years.

Read the detailed description

This study is designed to demonstrate the non-inferiority of the immune response in terms of geometric mean titers (GMTs) and seroconversion rates for the 3 strains (A/H1N1, A-H3N2, and B) after a single dose of either the SP Shz TIV or Hualan TIV. Vaccine immune responses will be assessed on Day 0 (pre-vaccination) and Day 28 post-vaccination. Solicited reactions will be collected from Day 0 up to Day 7 after vaccination, unsolicited non-serious adverse events (AEs) will be collected from Day 0 up to Day 28 post-vaccination, and serious AEs will be collected from Day 0 up to 6 months post-vaccination.

Conditions
Influenza, Flu
Being tested
SP Shz TIV, Hualan TIV
Keywords
Influenza, Flu
Medical subject headings
Influenza, Human

What participants receive

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

  • SP Shz TIVBiological

    Also called Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine

    0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0

  • Hualan TIVBiological

    Also called Hualan Trivalent Influenza Vaccine

    0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0

Study groups in NCT03344029
Study groupRoleWhat they receive
SP Shz TIVExperimentalParticipants aged 18 to 59 years will receive a single injection of SP Shz TIV.
Receives: Biological: SP Shz TIV
Hualan TIVActive comparatorParticipants aged 18 to 59 years will receive a single injection of Hualan TIV.
Receives: Biological: Hualan TIV

What is being measured

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

  1. Summary of Geometric Mean Titers (GMTs) of Each of the Three Strains of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV

    GMTs were assessed using the hemagglutination inhibition (HAI) assay.

    Measured: Day 28 post-vaccination

  2. Percentage of Participants with TIV Seroconversion Following a Single Dose of SP Shz TIV or Hualan TIV

    Seroconversion rates were assessed using a HAI assay. Seroconversion was defined as titers <10 (1/dil) at Day 0 and post-injection titer ≥40 (1/dil) at Day 28, or titer ≥10 (1/dil) at Day 0 and a ≥4-fold increase in titer (1/dil) at Day 28.

    Measured: Day 28 post-vaccination

Secondary outcomes (5)

  1. GMTs of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV

    GMTs were assessed using the HAI assay.

    Measured: Day 28 post-vaccination

  2. GMT Ratios of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV

    GMTs were assessed using the HAI assay.

    Measured: Day 28 post-vaccination

  3. Percentage of Participants with TIV Antibody Titers ≥10 (1/dil) Following a Single Dose of SP Shz TIV or Hualan TIV

    TIV antibody levels were assessed using the HAI assay.

    Measured: Day 28 post-vaccination

  4. Percentage of Participants with TIV Antibody Titers ≥40 (1/dil) Following a Single Dose of SP Shz TIV or Hualan TIV

    TIV antibody levels were assessed using the HAI assay.

    Measured: Day 28 post-vaccination

  5. Percentage of Participants Reporting Solicited Injection site or Systemic Reactions Following a Single Dose of SP Shz TIV or Hualan TIV

    Solicited injection site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering

    Measured: Day 0 up to Day 7 post-vaccination

Timeline

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

  1. First posted17 Nov 2017
  2. Study start3 Nov 2017
  3. Primary completion22 May 2018
  4. Study completion22 May 2018

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
Model description
Blind-observer, monocenter, randomized, comparative, Phase IV study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03344029
Sponsor's protocol ID
FST00002
Other IDs
U1111-1183-5912
Status last verified
Apr 2022
First submitted
9 Nov 2017
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Hu Y, Chu K, Lavis N, Li X, Liang B, Liu S, Shao M, Shu JD, Tabar C, Samson S. Immunogenicity and safety of a trivalent inactivated influenza vaccine produced in Shenzhen, China versus a comparator influenza vaccine: a phase IV randomized study. Hum Vaccin Immunother. 2019;15(5):1066-1069. doi: 10.1080/21645515.2019.1581541. Epub 2019 Apr 2.

    PubMed 30779689

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SP Shz TIV and Hualan TIV in people with Influenza and Flu, run by Sanofi 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 15 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 25 Apr 2022. 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?

Summary of Geometric Mean Titers (GMTs) of Each of the Three Strains of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV (time frame: Day 28 post-vaccination). The study lists 2 primary outcomes in all. 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 NCT03344029, 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 25 Apr 2022.

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