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AzTrials

InfluenzaPhase 1NCT03430089

Safety of a Single Dose or Two Doses of Shenzhen Quadrivalent Influenza Vaccine

A Phase 1 study testing Shz QIV 0.25 mL, 2 doses, Shz QIV 0.5 mL, 2 doses and Shz QIV 0.5 mL, single dose in people with Influenza and Flu, run by Sanofi Pasteur, a Sanofi Company 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 phase I-like, open-label, monocenter, descriptive, single-arm clinical safety study will investigate the Shenzhen quadrivalent influenza vaccine (Shz QIV) in 100 participants aged 6 months and older in China. Read more about this study

Who is it for?
Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Flu
What is being tested?
Shz QIV 0.25 mL, 2 doses, Shz QIV 0.5 mL, 2 doses and Shz QIV 0.5 mL, single dose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteChina
Study dates
22 Feb 2019to 6 Jun 2019
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 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 inclusion
  • 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 participant if aged 8 through 17 years (based on local regulations) For participants aged 18 years and older: Informed consent form has been signed and dated by the participant
  • Participant / Participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
  • For participants aged less than 2 years only: Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 kg

Who cannot join

  • Participant 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, surgically sterile
  • Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination [or the first 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 4 weeks before study vaccination (or the first study vaccination) to 4 weeks following study vaccination (or the last study vaccination)
  • Previous vaccination against influenza with either the study vaccine or another vaccine from the current season
  • Receipt of any vaccine or planned receipt of any vaccine within the period from 2 weeks before trial vaccination (or the first trial vaccination) to 2 weeks following trial vaccination (or the last trial vaccination)
  • For participants aged 6 to 8 years only: Previous vaccination against influenza vaccine in the past
Show all 16Show fewer
  • For participants aged 9 years and older: Previous vaccination against influenza (in the previous 6 months) with either the trial vaccine or another vaccine
  • 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 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
  • 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 participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • 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

  • Investigational Site 002

    Xishuangbanna Dai Autonomous Prefecture, Yunnan

Other trials in China

About this study

Official title: Safety of a Single Dose (Participants Aged 9 Years and Older) or Two Doses Given 28 Days Apart (Participants Aged 6 Months to 8 Years) of the Shenzhen Quadrivalent Influenza Vaccine (Split Virion), Inactivated

This phase I-like, open-label, monocenter, descriptive, single-arm clinical safety study will investigate the Shenzhen quadrivalent influenza vaccine (Shz QIV) in 100 participants aged 6 months and older in China.

Participants aged 9 years or more will receive a single dose of Shz QIV, and participants aged 6 months to 8 years will receive two doses of Shz QIV administered 28 days apart.

Read the detailed description

Healthy participants will either receive a single dose (participants 9 years or older) or two doses (participants 6 months to 8 years) of the Shz QIV. Safety in terms of serious adverse events, solicited injection site and systemic reactions, and unsolicited adverse events will be collected before and 28 days after each and any dose.

Conditions
Influenza, Flu
Being tested
Shz QIV 0.25 mL, 2 doses, Shz QIV 0.5 mL, 2 doses, Shz QIV 0.5 mL, single dose
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.

  • Shz QIV 0.25 mL, 2 dosesBiological

    Administered intramuscularly in the anterolateral aspect of the thigh in infants (aged 6 to 12 months) or into the deltoid muscle (participants aged more than 12 months), 28 days apart.

  • Shz QIV 0.5 mL, 2 dosesBiological

    Administered intramuscularly into the deltoid muscle, 28 days apart

  • Shz QIV 0.5 mL, single doseBiological

    Administered intramuscularly into the deltoid muscle.

Study groups in NCT03430089
Study groupRoleWhat they receive
Group 1: 6 to 35 monthsExperimentalShz QIV 0.25 mL, 2 doses
Receives: Biological: Shz QIV 0.25 mL, 2 doses
Group 2: 3 to 8 yearsExperimentalShz QIV 0.5 mL, 2 doses
Receives: Biological: Shz QIV 0.5 mL, 2 doses
Group 3: 9 to 17 yearsExperimentalShz QIV 0.5 mL, single dose
Receives: Biological: Shz QIV 0.5 mL, single dose
Group 4: 18 to 60 yearsExperimentalShz QIV 0.5 mL, single dose
Receives: Biological: Shz QIV 0.5 mL, single dose
Group 5: 61 years and olderExperimentalShz QIV 0.5 mL, single dose
Receives: Biological: Shz QIV 0.5 mL, single dose

What is being measured

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

  1. Occurrence of serious adverse reactions or Grade 3 non-serious adverse reactions following vaccination with Shz QIV

    Number of participants reporting serious adverse reactions and Grade 3 adverse reactions following a vaccination with Shz QIV

    Measured: Within 28 days after vaccination

Secondary outcomes (4)

  1. Occurrence of unsolicited systemic AEs reported in the 30 minutes following vaccination/each and any vaccination

    Measured: Within 30 minutes after vaccination

  2. Occurrence of solicited (prelisted in the subject diary and the electronic Case Report Form [CRF]) injection site reactions and systemic reactions occurring between D0 and D7 after vaccination/each and any vaccination

    Measured: Up to 7 days after vaccination

  3. Occurrence of unsolicited (spontaneously reported) AEs from D0 to D28 after vaccination/each and any vaccination

    Measured: Up to 7 days after vaccination

  4. Occurrence of SAEs

    Measured: Up to 56 days after the 1st vaccination

Timeline

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

  1. First posted12 Feb 2018
  2. Study start22 Feb 2019
  3. Primary completion6 Jun 2019
  4. Study completion6 Jun 2019

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
Model description
Phase I-like, open-label, descriptive, monocenter study, which includes 5 groups of participants of varying ages and doses
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03430089
Sponsor's protocol ID
FSQ01
Other IDs
U1111-1174-4615
Status last verified
Nov 2022
First submitted
5 Feb 2018
Last updated
9 Nov 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

  • 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 1 study testing Shz QIV 0.25 mL, 2 doses, Shz QIV 0.5 mL, 2 doses and Shz QIV 0.5 mL, single dose in people with Influenza and Flu, run by Sanofi Pasteur, a Sanofi Company 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 4 inclusion and 16 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 9 Nov 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 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?

Occurrence of serious adverse reactions or Grade 3 non-serious adverse reactions following vaccination with Shz QIV (time frame: Within 28 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 NCT03430089, 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 9 Nov 2022.

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