Clinical trial NCT04210349: Study of Shenzhen Quadrivalent Inactivated Influenza Vaccine Versus the Shenzhen Trivalent Inactivated Influenza Vaccine in Chinese Subjects From 6 Months of Age
Official title: Immunogenicity and Safety of the Shenzhen Quadrivalent Inactivated Influenza Vaccine Versus the Shenzhen Trivalent Inactivated Influenza Vaccine in Chinese Subjects From 6 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-12-24
Enrollment: 7106
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Study duration per participants approximately is 180 days

Eligibility criteria: Inclusion criteria :

* Aged ≥ 6 months on the day of the first study visit/inclusion
* 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

Exclusion criteria:

* 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
* For previously influenza unvaccinated subjects: Any influenza vaccination (from birth to the day of inclusion) 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
* 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
* 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
* 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 (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

Primary outcomes:
measure: Geometric Mean Titers of Influenza Antibodies for Subjects 6-35 months
timeFrame: 28 days post-final vaccination
measure: Participants Achieving Seroconversion Against Antigens for Subjects 6-35 months
timeFrame: 28 days post-final vaccination
measure: Geometric Mean Titers of Antibodies for Subjects ≥ 3 years
timeFrame: Day 28
measure: Number of Participants Achieving Seroconversion Against Antigens for Subjects ≥ 3 years
timeFrame: Day 28
measure: Number of Participants with Immediate Adverse Events
timeFrame: Within 30 minutes after vaccination
measure: Number of Participants With Solicited Injection Site or Systemic Reactions
timeFrame: Within 7 days after vaccination
measure: Number of Participants with Unsolicited Adverse Events
timeFrame: Within 28 days after vaccination
measure: Number of Participants with Serious Adverse Events
timeFrame: 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:
measure: Geometric Mean Titers of Antibodies
timeFrame: Day 0 and 28 days post-final vaccination
measure: Geometric Mean Individual Titer Ratio
timeFrame: Day 0 and 28 days post-final vaccination
measure: Number of Participants with Detectable Titer ≥ 10 (1/dilution [1/dil])
timeFrame: Day 0 and 28 days post-final vaccination
measure: Percentage of Participants with Seroprotection to Antigens After Vaccination
timeFrame: Day 0 and 28 days post-final vaccination
measure: Percentage of Participants with Seroconversion to Antigens After Vaccination
timeFrame: Day 0 and 28 days post-final vaccination
measure: Geometric Mean Individual Titer Ratio for Participants Aged 65 years or Older
timeFrame: Day 0 and 28 days post-final vaccination
measure: Percentage of Participants with Seroconversion to Antigens After Vaccination for Participants Aged 65 years or Older
timeFrame: Day 0 and 28 days post-final vaccination
Other outcomes:
Locations:
city: Kunming
country: China
facility: Investigational Site Number 1561000
city: Lincang
country: China
facility: Investigational Site Number 1561001
city: Lincang
country: China
facility: Investigational Site Number 1561002
city: Lincang
country: China
facility: Investigational Site Number 1561003
city: Shangqiu
country: China
facility: Investigational Site Number 1562001
city: Xinxiang
country: China
facility: Investigational Site Number 1562002
city: Zhengzhou
country: China
facility: Investigational Site Number 1562000
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.