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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430089
• Other study ID #: FSQ01
• Secondary ID: U1111-1174-4615
• Status: Completed
• Phase: Phase 1
• Start date: February 22, 2019
• Est. completion date: June 6, 2019

Study information

• Verified date: November 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

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 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

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 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
• 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

Related Conditions & MeSH terms

• Flu
• Influenza
• Influenza, Human

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.
• Shz QIV 0.5 mL, 2 doses
Administered intramuscularly into the deltoid muscle, 28 days apart
• Shz QIV 0.5 mL, single dose
Administered intramuscularly into the deltoid muscle.

Locations

Country	Name	City	State
China	Investigational Site 002	Xishuangbanna	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 28 days after vaccination
Secondary	Occurrence of unsolicited systemic AEs reported in the 30 minutes following vaccination/each and any vaccination		Within 30 minutes after vaccination
Secondary	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
Secondary	Occurrence of unsolicited (spontaneously reported) AEs from D0 to D28 after vaccination/each and any vaccination		Up to 7 days after vaccination
Secondary	Occurrence of SAEs		Up to 56 days after the 1st vaccination

External Links

•   Immunological non-inferiority and safety of a quadrivalent inactivated influenza vaccine versus two trivalent inactivated influenza vaccines in China: Results from two studies
•   Related info