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Shz QIV, 2 doses

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Nov 9, 2022

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment101

FDA Designations

No designations recorded

Clinical trial landscape

Shz QIV, 2 doses · 1 trial · 2 indications

Phase 1 1
NCT03430089Safety of a Single Dose or Two Doses of Shenzhen Quadrivalent Influenza VaccineInfluenza
COMPLETED101 Analytics
PHASE1COMPLETED
Safety of a Single Dose or Two Doses of Shenzhen Quadrivalent Influenza Vaccine
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of serious adverse reactions or Grade 3 non-serious adverse reactions following vaccination with Shz QIV
Within 28 days after vaccination

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

Secondary Endpoints

Occurrence of unsolicited systemic AEs reported in the 30 minutes following vaccination/each and any vaccination
Within 30 minutes after vaccination
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
Up to 7 days after vaccination
Occurrence of unsolicited (spontaneously reported) AEs from D0 to D28 after vaccination/each and any vaccination
Up to 7 days after vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1: 6 to 35 monthsEXPERIMENTALShz QIV 0.25 mL, 2 doses
Group 2: 3 to 8 yearsEXPERIMENTALShz QIV 0.5 mL, 2 doses
Group 3: 9 to 17 yearsEXPERIMENTALShz QIV 0.5 mL, single dose
Group 4: 18 to 60 yearsEXPERIMENTALShz QIV 0.5 mL, single dose
Group 5: 61 years and olderEXPERIMENTALShz QIV 0.5 mL, single dose

Interventions

NameTypeDescription
Shz QIV 0.25 mL, 2 dosesBIOLOGICALAdministered 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 dosesBIOLOGICALAdministered intramuscularly into the deltoid muscle, 28 days apart
Shz QIV 0.5 mL, single doseBIOLOGICALAdministered intramuscularly into the deltoid muscle.
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Eligibility Criteria

Age Range6 Months to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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...

Countries:China
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Frequently asked questions about Shz QIV, 2 doses

What is Shz QIV, 2 doses?

Shz QIV, 2 doses is an investigational quadrivalent influenza vaccine candidate developed by Sanofi. It is being studied for the prevention of influenza, also known as the flu, and was evaluated in a two-dose regimen in a Phase 1 clinical trial conducted in China.

What is Shz QIV, 2 doses used for?

Shz QIV, 2 doses is being developed for the prevention of influenza, or flu. The Phase 1 study enrolled healthy volunteers, including children as young as 6 months of age, and evaluated a two-dose schedule of the quadrivalent influenza vaccine candidate.

Who makes Shz QIV, 2 doses?

Shz QIV, 2 doses is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating this quadrivalent influenza vaccine candidate.

What phase is Shz QIV, 2 doses in?

Shz QIV, 2 doses is in Phase 1 clinical development. It is an investigational vaccine candidate and has not been approved by the FDA. The completed Phase 1 trial assessed the safety of a single dose or two doses of the Shenzhen quadrivalent influenza vaccine.

What clinical trials is Shz QIV, 2 doses in?

Shz QIV, 2 doses was evaluated in one completed Phase 1 trial, NCT03430089, titled Safety of a Single Dose or Two Doses of Shenzhen Quadrivalent Influenza Vaccine. The trial enrolled 101 healthy volunteers in China, including participants aged 6 months and older, and used a controlled design.