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

ID: NCT03430089
Status: Not yet recruiting
Phase: Phase 1
Start Date: September 18, 2018
First Submitted: February 05, 2018
Last Updated: February 09, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi Pasteur, a Sanofi Company
Location: China
Conditions: Influenza, Flu
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Study Description

Brief 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.

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.

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.
Condition or disease Intervention/treatment Phase

Flu

Influenza

Biological: Shz QIV 0.25 mL, 2 doses
Other Names
Biological: Shz QIV 0.5 mL, 2 doses
Other Names
Biological: Shz QIV 0.5 mL, single dose
Other Names
Phase 1

Tracking Information

First Submitted DateFebruary 05, 2018
Last Update Posted DateFebruary 09, 2018
Anticipated Start DateSeptember 18, 2018
Anticipated Completion DateJanuary 08, 2019
Anticipated Primary Completion DateJanuary 08, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Occurrence of serious adverse reactions or Grade 3 non-serious adverse reactions following vaccination with Shz QIV [Time Frame: Within 28 days after vaccination]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Occurrence of solicited injection site or systemic reactions after vaccination with Shz QIV [Time Frame: Within 7 days after vaccination]

    Percentage of participants reporting solicited injection site or systemic reactions after vaccination with Shz QIV

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSafety of a Single Dose or Two Doses of Shenzhen Quadrivalent Influenza Vaccine
Official TitleSafety 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
Brief 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.

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.

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.

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
100
Allocation
Non-Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Prevention
Conditions
Flu
Influenza
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Biological: Shz QIV 0.25 mL, 2 doses

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.

Other Names
Biological: Shz QIV 0.5 mL, 2 doses

Administered intramuscularly into the deltoid muscle, 28 days apart

Other Names
Biological: Shz QIV 0.5 mL, single dose

Administered intramuscularly into the deltoid muscle.

Other Names
Study Groups/Cohorts
Group 1: 6 to 35 months
Shz QIV 0.25 mL, 2 doses

Group 2: 3 to 8 years
Shz QIV 0.5 mL, 2 doses

Group 3: 9 to 17 years
Shz QIV 0.5 mL, single dose

Group 4: 18 to 60 years
Shz QIV 0.5 mL, single dose

Group 5: 61 years and older
Shz QIV 0.5 mL, single dose

Study Arms
Experimental Group 1: 6 to 35 months
Shz QIV 0.25 mL, 2 doses
Biological : Shz QIV 0.25 mL, 2 doses
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.

Experimental Group 2: 3 to 8 years
Shz QIV 0.5 mL, 2 doses
Biological : Shz QIV 0.5 mL, 2 doses
Administered intramuscularly into the deltoid muscle, 28 days apart

Experimental Group 3: 9 to 17 years
Shz QIV 0.5 mL, single dose
Biological : Shz QIV 0.5 mL, single dose
Administered intramuscularly into the deltoid muscle.

Experimental Group 4: 18 to 60 years
Shz QIV 0.5 mL, single dose
Biological : Shz QIV 0.5 mL, single dose
Administered intramuscularly into the deltoid muscle.

Experimental Group 5: 61 years and older
Shz QIV 0.5 mL, single dose
Biological : Shz QIV 0.5 mL, single dose
Administered intramuscularly into the deltoid muscle.

Arm Intervention/Treatment
Experimental Group 1: 6 to 35 months
Shz QIV 0.25 mL, 2 doses
Biological : Shz QIV 0.25 mL, 2 doses
Experimental Group 2: 3 to 8 years
Shz QIV 0.5 mL, 2 doses
Biological : Shz QIV 0.5 mL, 2 doses
Experimental Group 3: 9 to 17 years
Shz QIV 0.5 mL, single dose
Biological : Shz QIV 0.5 mL, single dose
Experimental Group 4: 18 to 60 years
Shz QIV 0.5 mL, single dose
Biological : Shz QIV 0.5 mL, single dose
Experimental Group 5: 61 years and older
Shz QIV 0.5 mL, single dose
Biological : Shz QIV 0.5 mL, single dose

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment100
Completion DateJanuary 08, 2019
Eligibility Criteria: 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 participant if aged 10 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
- For participants aged 6 months to 8 years only: Participant had never been vaccinated with influenza vaccine in the past

Exclusion Criteria:
- 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 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
- 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
GenderAll
Age6 Months to N/A
Accepts Healthy VolunteersAccepts Healthy Volunteers
Contacts
Listed Location Countries
China

Administrative Information

NCT Number:NCT03430089
Other Study ID Numbers
FSQ01
U1111-1174-4615
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Collaborators
Not Available
Investigators
Study Director
Medical Director
Sanofi Pasteur, a Sanofi Company