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

NCT03430089 | Completed Phase 1

• 2 other identifiers: FSQ01U1111-1174-4615
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza; Flu

Keywords

Influenza; Flu

Outcome Measures

Primary Outcomes (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

  Within 28 days after vaccination

Secondary Outcomes (4)

• 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

• Occurrence of SAEs

  Up to 56 days after the 1st vaccination

Study Arms (5)

Group 1: 6 to 35 months

EXPERIMENTAL

Shz QIV 0.25 mL, 2 doses

Biological: Shz QIV 0.25 mL, 2 doses

Group 2: 3 to 8 years

EXPERIMENTAL

Shz QIV 0.5 mL, 2 doses

Biological: Shz QIV 0.5 mL, 2 doses

Group 3: 9 to 17 years

EXPERIMENTAL

Shz QIV 0.5 mL, single dose

Biological: Shz QIV 0.5 mL, single dose

Group 4: 18 to 60 years

EXPERIMENTAL

Shz QIV 0.5 mL, single dose

Biological: Shz QIV 0.5 mL, single dose

Group 5: 61 years and older

EXPERIMENTAL

Shz QIV 0.5 mL, single dose

Biological: Shz QIV 0.5 mL, single dose

Interventions

Shz QIV 0.25 mL, 2 doses BIOLOGICAL

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.

Group 1: 6 to 35 months

Shz QIV 0.5 mL, 2 doses BIOLOGICAL

Administered intramuscularly into the deltoid muscle, 28 days apart

Group 2: 3 to 8 years

Shz QIV 0.5 mL, single dose BIOLOGICAL

Administered intramuscularly into the deltoid muscle.

Group 3: 9 to 17 years; Group 4: 18 to 60 years; Group 5: 61 years and older

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Investigational Site 002

Xishuangbanna Dai Autonomous Prefecture, Yunnan, China

Location

Related Publications (1)

• 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.

  PMID: 36328438 DERIVED

Related Links

• Related info

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I-like, open-label, descriptive, monocenter study, which includes 5 groups of participants of varying ages and doses

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: February 22, 2019
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)