Study of Shenzhen Quadrivalent Inactivated Influenza Vaccine Versus the Shenzhen Trivalent Inactivated Influenza Vaccine in Chinese Subjects From 6 Months of Age

NCT04210349 | Completed Phase 3

• 2 other identifiers: FSQ02U1111-1174-4698
• Study Type: interventional
• Target: 7,106
• Locations: 1 country
• Sites: 7

Brief Summary

The primary objectives of the study were:

• To demonstrate the non-inferiority of the immune response in terms of geometric mean titers (GMTs) and seroconversion rates of the SP Shz QIV compared with the SP Shz TIV containing the Victoria lineage strain (TIV1) and the SP Shz TIV containing the Yamagata lineage strain (TIV2) for each strain
• To describe the safety profile of each dosage of SP Shz QIV, TIV1 or TIV2 The secondary objectives of the study were:
• Group 1 (subjects 6-35 months): To demonstrate the superiority of the immune response of SP Shz QIV compared to TIV2 or TIV1 group after the last dose; demonstrate the superiority of the immune response of the 0.5 mL dose of SP Shz QIV compared to 0.25 mL dose of SP Shz QIV group after the last dose; describe the immune response after administration of the last dose of either SP Shz QIV or SP Shz TIV1 or SP Shz TIV2.
• Groups 2 through 5 (subjects ≥ 3 years): To demonstrate the superiority of the immune response of SP Shz QIV compared to TIV2 or TIV1 group after a single dose; describe the immune response after each and every dose for all subjects ≥ 3 years of either SP Shz QIV or SP Shz TIV1 or SP Shz TIV2
• Group 2 (subjects 3 to 8 years), previously unvaccinated ,receiving SP Shz QIV: To describe the immune response after administration of each dose of SP Shz QIV, first dose and second dose of SP Shz QIV respectively
• Group 5 (subjects ≥ 65 years only): To assess the compliance, in terms of immunogenicity, of SP Shz QIV with the requirements of the CHMP NfG CPMP/BWP/214/96 in subjects aged 65 years or older.
• To describe the safety profile of SP Shz QIV 0.5 mL after each dose.

Conditions

Influenza

Outcome Measures

Primary Outcomes (8)

• Geometric Mean Titers of Influenza Antibodies for Subjects 6-35 months

  Geometric mean titers will be assessed by a hemagglutination (HAI) method

  28 days post-final vaccination

• Participants Achieving Seroconversion Against Antigens for Subjects 6-35 months

  Influenza antibodies will be assessed using the HAI method.

  28 days post-final vaccination

• Geometric Mean Titers of Antibodies for Subjects ≥ 3 years

  Geometric mean titers will be assessed by a HAI method

  Day 28

• Number of Participants Achieving Seroconversion Against Antigens for Subjects ≥ 3 years

  Influenza antibodies will be assessed using the HAI method.

  Day 28

• Number of Participants with Immediate Adverse Events

  Immediate adverse events includes unsolicited systemic adverse events occuring within 30 minutes after vaccination

  Within 30 minutes after vaccination

• Number of Participants With Solicited Injection Site or Systemic Reactions

  Injection site reactions: injection site tenderness/pain, erythema, swelling, induration, and ecchymosis. Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability for toddlers aged \<= 23 months and fever, headache, malaise, myalgia and shivering for participants aged \> 2 years.

  Within 7 days after vaccination

• Number of Participants with Unsolicited Adverse Events

  Adverse events other than solicited reactions

  Within 28 days after vaccination

• Number of Participants with Serious Adverse Events

  Serious adverse events (including adverse event of special interest) are assessed throughout the study.

  From Day 0 to Day 56 for participants in Group A and from Day 0 to 6 months after last vaccination for participants in Group 1 through Group 5.

Secondary Outcomes (7)

• Geometric Mean Titers of Antibodies

  Day 0 and 28 days post-final vaccination

• Geometric Mean Individual Titer Ratio

  Day 0 and 28 days post-final vaccination

• Number of Participants with Detectable Titer ≥ 10 (1/dilution [1/dil])

  Day 0 and 28 days post-final vaccination

• Percentage of Participants with Seroprotection to Antigens After Vaccination

  Day 0 and 28 days post-final vaccination

• Percentage of Participants with Seroconversion to Antigens After Vaccination

  Day 0 and 28 days post-final vaccination

Study Arms (6)

Group A: 6 to 35 months, previously unvaccinated, step 1

EXPERIMENTAL

Participants will receive two injections of SP Shz QIV 0.5 mL at Day 0 and Day 28

Biological: Quadrivalent Influenza Vaccine

Group 1: 6 to 35 months, step 2

EXPERIMENTAL

Participants will receive one injection of SP Shz QIV 0.25 mL or SP Shz QIV 0.5 mL at Day 0 or SP Shz TIV1 0.25 mL or SP Shz TIV2 0.25 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

Biological: Quadrivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine 1 SP Shz TIV1; Biological: Trivalent Influenza Vaccine 2 SP Shz TIV2

Group 2: 3 to 8 years, step 2

EXPERIMENTAL

Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0. Participants for whom 2 doses of influenza vaccine were recommended, a second dose was administered at Day 28.

Biological: Quadrivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine 1 SP Shz TIV1; Biological: Trivalent Influenza Vaccine 2 SP Shz TIV2

Group 3: 9 to 17 years, step 2

EXPERIMENTAL

Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.

Biological: Quadrivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine 1 SP Shz TIV1; Biological: Trivalent Influenza Vaccine 2 SP Shz TIV2

Group 4: 18 to 60 years, step 2

EXPERIMENTAL

Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.

Biological: Quadrivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine 1 SP Shz TIV1; Biological: Trivalent Influenza Vaccine 2 SP Shz TIV2

Group 5: >=61 years

EXPERIMENTAL

Participants will receive one injection of SP Shz QIV 0.5 mL or SP Shz TIV1 0.5 mL or SP Shz TIV2 0.5 mL at Day 0.

Biological: Quadrivalent Influenza Vaccine; Biological: Trivalent Influenza Vaccine 1 SP Shz TIV1; Biological: Trivalent Influenza Vaccine 2 SP Shz TIV2

Interventions

Quadrivalent Influenza Vaccine BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: intramuscular

Group 1: 6 to 35 months, step 2; Group 2: 3 to 8 years, step 2; Group 3: 9 to 17 years, step 2; Group 4: 18 to 60 years, step 2; Group 5: >=61 years; Group A: 6 to 35 months, previously unvaccinated, step 1

Trivalent Influenza Vaccine 1 SP Shz TIV1 BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: intramuscular

Group 1: 6 to 35 months, step 2; Group 2: 3 to 8 years, step 2; Group 3: 9 to 17 years, step 2; Group 4: 18 to 60 years, step 2; Group 5: >=61 years

Trivalent Influenza Vaccine 2 SP Shz TIV2 BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: intramuscular

Group 1: 6 to 35 months, step 2; Group 2: 3 to 8 years, step 2; Group 3: 9 to 17 years, step 2; Group 4: 18 to 60 years, step 2; Group 5: >=61 years

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:

• In good health or with underlying medical condition(s) that are judged to be stable by the investigator. Medically-stable is defined as:
• No new diagnosis OR
• No new class of prescription drug initiated during the 3 months prior to enrollment
• 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 subject if aged 8 through 17 years (based on local regulations). For subjects aged 18 years and above: Informed consent form has been signed and dated
• Subject / subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
• For subjects aged 6 months to less than 12 months only: Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

You may not qualify if:

• Subject 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, or surgically sterile
• Participation at the time of study enrollment (or in the 4 weeks preceding the 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 to 2 weeks following trial vaccination (or the last trial vaccination)
• For previously influenza vaccinated subjects: Previous vaccination against influenza (in the 2019-2020 season) with either the trial vaccine or another vaccine
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• 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 intramuscular (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
• Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder
• Known seropositivity for human immunodeficiency virus, including known HIV carrier or patient
• 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 subject should not be included in the study until the condition has resolved or the febrile event has subsided
• Personal history of Guillain-Barre syndrome

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (7)

Investigational Site Number 1561000

Kunming, 650022, China

Location

Investigational Site Number 1561001

Lincang, 677001, China

Location

Investigational Site Number 1561002

Lincang, 677001, China

Location

Investigational Site Number 1561003

Lincang, 677001, China

Location

Investigational Site Number 1562001

Shangqiu, 476000, China

Location

Investigational Site Number 1562002

Xinxiang, 453200, China

Location

Investigational Site Number 1562000

Zhengzhou, 450002, 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

• FSQ02 Plain Language Results Summary

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Open-label (single arm for early safety review) in step 1. Modified double-blind in step 2 with an unblinded administrator used at each trial site. The administrator will not be involved in any of the blinded study assessments (e.g., safety).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 24, 2019
• Study Start: January 9, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (7)