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InfluenzaPhase 3NCT04210349

Study of Shenzhen Quadrivalent Inactivated Influenza Vaccine Versus the Shenzhen Trivalent Inactivated Influenza Vaccine in Chinese Subjects From 6 Months of Age

A Phase 3 study testing Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine 1 SP Shz TIV1 and Trivalent Influenza Vaccine 2 SP Shz TIV2 in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 7 sites 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 primary objectives of the study were: To demonstrate the non-inferiority of the immune response in terms of geometric mean titers (GMTs) and seroconversion rates of the SP Shz QIV compared with the SP Shz TIV containing the Victoria lineage strain (TIV1) and the SP Shz TIV containing the Yamagata lineage strain… 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?
Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine 1 SP Shz TIV1 and Trivalent Influenza Vaccine 2 SP Shz TIV2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,106 participants
Where
7 sitesChina
Study dates
9 Jan 2020to 1 Dec 2020
Phase
Phase 3
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

  • Aged ≥ 6 months on the day of the first study visit/inclusion
  • In good health or with underlying medical condition(s) that are judged to be stable by the investigator. Medically-stable is defined as:
  • No new diagnosis OR
  • No new class of prescription drug initiated during the 3 months prior to enrollment
  • For participants aged 6 months through 17 years: Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative, if applicable. Additionally an assent form has been signed and dated by the subject if aged 8 through 17 years (based on local regulations). For subjects aged 18 years and above: Informed consent form has been signed and dated
  • Subject / subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
  • For subjects aged 6 months to less than 12 months only: Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

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 pre-menarche or 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 (or the last trial vaccination)
  • For previously influenza vaccinated subjects: Previous vaccination against influenza (in the 2019-2020 season) with either the trial vaccine or another vaccine
  • For previously influenza unvaccinated subjects: Any influenza vaccination (from birth to the day of inclusion) with either the trial vaccine or another vaccine
  • Receipt of immune globulins, blood or blood-derived products in the past 3 months
Show all 18Show fewer
  • 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)
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
  • Self-reported thrombocytopenia or known thrombocytopenia as reported by the parent/legally acceptable representative, contraindicating intramuscular (IM) vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM 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
  • Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder
  • Known seropositivity for human immunodeficiency virus, including known HIV carrier or patient
  • 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
  • Personal history of Guillain-Barre syndrome
  • 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 (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Investigational Site Number 1561000

    Kunming, 650022

  • Investigational Site Number 1561001

    Lincang, 677001

  • Investigational Site Number 1561002

    Lincang, 677001

  • Investigational Site Number 1561003

    Lincang, 677001

  • Investigational Site Number 1562001

    Shangqiu, 476000

  • Investigational Site Number 1562002

    Xinxiang, 453200

  • Investigational Site Number 1562000

    Zhengzhou, 450002

Other trials in China

About this study

Official title: Immunogenicity and Safety of the Shenzhen Quadrivalent Inactivated Influenza Vaccine Versus the Shenzhen Trivalent Inactivated Influenza Vaccine in Chinese Subjects From 6 Months of Age

The primary objectives of the study were:

  • To demonstrate the non-inferiority of the immune response in terms of geometric mean titers (GMTs) and seroconversion rates of the SP Shz QIV compared with the SP Shz TIV containing the Victoria lineage strain (TIV1) and the SP Shz TIV containing the Yamagata lineage strain (TIV2) for each strain
  • To describe the safety profile of each dosage of SP Shz QIV, TIV1 or TIV2
Read more

The secondary objectives of the study were:

  • Group 1 (subjects 6-35 months): To demonstrate the superiority of the immune response of SP Shz QIV compared to TIV2 or TIV1 group after the last dose; demonstrate the superiority of the immune response of the 0.5 mL dose of SP Shz QIV compared to 0.25 mL dose of SP Shz QIV group after the last dose; describe the immune response after administration of the last dose of either SP Shz QIV or SP Shz TIV1 or SP Shz TIV2.
  • Groups 2 through 5 (subjects ≥ 3 years): To demonstrate the superiority of the immune response of SP Shz QIV compared to TIV2 or TIV1 group after a single dose; describe the immune response after each and every dose for all subjects ≥ 3 years of either SP Shz QIV or SP Shz TIV1 or SP Shz TIV2
  • Group 2 (subjects 3 to 8 years), previously unvaccinated ,receiving SP Shz QIV: To describe the immune response after administration of each dose of SP Shz QIV, first dose and second dose of SP Shz QIV respectively
  • Group 5 (subjects ≥ 65 years only): To assess the compliance, in terms of immunogenicity, of SP Shz QIV with the requirements of the CHMP NfG CPMP/BWP/214/96 in subjects aged 65 years or older.
  • To describe the safety profile of SP Shz QIV 0.5 mL after each dose.
Read the detailed description

Study duration per participants approximately is 180 days

Conditions
Influenza
Being tested
Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine 1 SP Shz TIV1, Trivalent Influenza Vaccine 2 SP Shz TIV2
Medical subject headings
Influenza, Human

What participants receive

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

  • Quadrivalent Influenza VaccineBiological

    Pharmaceutical form: Suspension for injection Route of administration: intramuscular

  • Trivalent Influenza Vaccine 1 SP Shz TIV1Biological

    Pharmaceutical form: Suspension for injection Route of administration: intramuscular

  • Trivalent Influenza Vaccine 2 SP Shz TIV2Biological

    Pharmaceutical form: Suspension for injection Route of administration: intramuscular

Study groups in NCT04210349
Study groupRoleWhat they receive
Group A: 6 to 35 months, previously unvaccinated, step 1ExperimentalParticipants will receive two injections of SP Shz QIV 0.5 mL at Day 0 and Day 28
Receives: Biological: Quadrivalent Influenza Vaccine
Group 1: 6 to 35 months, step 2ExperimentalParticipants will receive one injection of SP Shz QIV 0.25 mL or SP Shz QIV 0.5 mL at Day 0 or SP Shz TIV1 0.25 mL or SP Shz TIV2 0.25 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Receives: Biological: Quadrivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine 1 SP Shz TIV1; Biological: Trivalent Influenza Vaccine 2 SP Shz TIV2
Group 2: 3 to 8 years, step 2ExperimentalParticipants will receive one injection of SP Shz QIV 0.5 mL or SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.
Receives: Biological: Quadrivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine 1 SP Shz TIV1; Biological: Trivalent Influenza Vaccine 2 SP Shz TIV2
Group 3: 9 to 17 years, step 2ExperimentalParticipants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
Receives: Biological: Quadrivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine 1 SP Shz TIV1; Biological: Trivalent Influenza Vaccine 2 SP Shz TIV2
Group 4: 18 to 60 years, step 2ExperimentalParticipants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
Receives: Biological: Quadrivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine 1 SP Shz TIV1; Biological: Trivalent Influenza Vaccine 2 SP Shz TIV2
Group 5: >=61 yearsExperimentalParticipants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.
Receives: Biological: Quadrivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine 1 SP Shz TIV1; Biological: Trivalent Influenza Vaccine 2 SP Shz TIV2

What is being measured

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

  1. Geometric Mean Titers of Influenza Antibodies for Subjects 6-35 months

    Geometric mean titers will be assessed by a hemagglutination (HAI) method

    Measured: 28 days post-final vaccination

  2. Participants Achieving Seroconversion Against Antigens for Subjects 6-35 months

    Influenza antibodies will be assessed using the HAI method.

    Measured: 28 days post-final vaccination

  3. Geometric Mean Titers of Antibodies for Subjects ≥ 3 years

    Geometric mean titers will be assessed by a HAI method

    Measured: Day 28

  4. Number of Participants Achieving Seroconversion Against Antigens for Subjects ≥ 3 years

    Influenza antibodies will be assessed using the HAI method.

    Measured: Day 28

  5. Number of Participants with Immediate Adverse Events

    Immediate adverse events includes unsolicited systemic adverse events occuring within 30 minutes after vaccination

    Measured: Within 30 minutes after vaccination

  6. Number of Participants With Solicited Injection Site or Systemic Reactions

    Injection site reactions: injection site tenderness/pain, erythema, swelling, induration, and ecchymosis. Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability for toddlers aged <= 23 months and fever, headache, malaise, myalgia and shivering for participants aged > 2 years.

    Measured: Within 7 days after vaccination

  7. Number of Participants with Unsolicited Adverse Events

    Adverse events other than solicited reactions

    Measured: Within 28 days after vaccination

  8. Number of Participants with Serious Adverse Events

    Serious adverse events (including adverse event of special interest) are assessed throughout the study.

    Measured: From Day 0 to Day 56 for participants in Group A and from Day 0 to 6 months after last vaccination for participants in Group 1 through Group 5.

Secondary outcomes (7)

  1. Geometric Mean Titers of Antibodies

    Geometric mean titers will be assessed by a HAI method.

    Measured: Day 0 and 28 days post-final vaccination

  2. Geometric Mean Individual Titer Ratio

    Geometric mean titers will be assessed by a HAI method.

    Measured: Day 0 and 28 days post-final vaccination

  3. Number of Participants with Detectable Titer ≥ 10 (1/dilution [1/dil])

    Geometric mean titers will be assessed by an HAI method.

    Measured: Day 0 and 28 days post-final vaccination

  4. Percentage of Participants with Seroprotection to Antigens After Vaccination

    Seroprotection was defined as antibody titer ≥ 40 (1/dil) on Day 0 and on 28 days post-final vaccination

    Measured: Day 0 and 28 days post-final vaccination

  5. Percentage of Participants with Seroconversion to Antigens After Vaccination

    Seroconversion titer < 10 (1/dil) on Day 0 and post-injection(s) titer ≥ 40 (1/dil) on Day 28 or Day 56, or titer ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection(s) titer on 28 days post-final vaccination.

    Measured: Day 0 and 28 days post-final vaccination

  6. Geometric Mean Individual Titer Ratio for Participants Aged 65 years or Older

    Geometric mean titers will be assessed by an HAI method.

    Measured: Day 0 and 28 days post-final vaccination

  7. Percentage of Participants with Seroconversion to Antigens After Vaccination for Participants Aged 65 years or Older

    Seroconversion titer < 10 (1/dil) on Day 0 and post-injection(s) titer ≥ 40 (1/dil) on Day 28, or titer ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection(s) titer on 28 days post-final vaccination.

    Measured: Day 0 and 28 days post-final vaccination

Timeline

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

  1. First posted24 Dec 2019
  2. Study start9 Jan 2020
  3. Primary completion1 Dec 2020
  4. Study completion1 Dec 2020

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
7,106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04210349
Sponsor's protocol ID
FSQ02
Other IDs
U1111-1174-4698
Status last verified
Sep 2025
First submitted
26 Nov 2019
Last updated
16 Sep 2025
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

  • Liu X, Park J, Xia S, Liang B, Yang S, Wang Y, Syrkina O, Lavis N, Liu S, Zhao C, Ding J, Hu J, Samson SI, de Bruijn IA; FSQ01 and FSQ02 Study Groups. Immunological non-inferiority and safety of a quadrivalent inactivated influenza vaccine versus two trivalent inactivated influenza vaccines in China: Results from two studies. Hum Vaccin Immunother. 2022 Nov 30;18(6):2132798. doi: 10.1080/21645515.2022.2132798. Epub 2022 Nov 3.

    PubMed 36328438

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quadrivalent Influenza Vaccine, Trivalent Influenza Vaccine 1 SP Shz TIV1 and Trivalent Influenza Vaccine 2 SP Shz TIV2 in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 7 sites 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 7 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Geometric Mean Titers of Influenza Antibodies for Subjects 6-35 months (time frame: 28 days post-final vaccination). The study lists 8 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 NCT04210349, 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 16 Sep 2025.

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