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.
Study duration per participants approximately is 180 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
7,106
Pharmaceutical form: Suspension for injection Route of administration: intramuscular
Pharmaceutical form: Suspension for injection Route of administration: intramuscular
Pharmaceutical form: Suspension for injection Route of administration: intramuscular
Investigational Site Number 1561000
Kunming, China
Investigational Site Number 1561001
Lincang, China
Investigational Site Number 1561002
Lincang, China
Investigational Site Number 1561003
Lincang, China
Investigational Site Number 1562001
Shangqiu, China
Investigational Site Number 1562002
Xinxiang, China
Investigational Site Number 1562000
Zhengzhou, China
Geometric Mean Titers of Influenza Antibodies for Subjects 6-35 months
Geometric mean titers will be assessed by a hemagglutination (HAI) method
Time frame: 28 days post-final vaccination
Participants Achieving Seroconversion Against Antigens for Subjects 6-35 months
Influenza antibodies will be assessed using the HAI method.
Time frame: 28 days post-final vaccination
Geometric Mean Titers of Antibodies for Subjects ≥ 3 years
Geometric mean titers will be assessed by a HAI method
Time frame: Day 28
Number of Participants Achieving Seroconversion Against Antigens for Subjects ≥ 3 years
Influenza antibodies will be assessed using the HAI method.
Time frame: Day 28
Number of Participants with Immediate Adverse Events
Immediate adverse events includes unsolicited systemic adverse events occuring within 30 minutes after vaccination
Time frame: 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.
Time frame: Within 7 days after vaccination
Number of Participants with Unsolicited Adverse Events
Adverse events other than solicited reactions
Time frame: 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.
Time frame: 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.
Geometric Mean Titers of Antibodies
Geometric mean titers will be assessed by a HAI method.
Time frame: Day 0 and 28 days post-final vaccination
Geometric Mean Individual Titer Ratio
Geometric mean titers will be assessed by a HAI method.
Time frame: Day 0 and 28 days post-final vaccination
Number of Participants with Detectable Titer ≥ 10 (1/dilution [1/dil])
Geometric mean titers will be assessed by an HAI method.
Time frame: Day 0 and 28 days post-final vaccination
Percentage of Participants with Seroprotection to Antigens After Vaccination
Seroprotection was defined as antibody titer ≥ 40 (1/dil) on Day 0 and on 28 days post-final vaccination
Time frame: Day 0 and 28 days post-final vaccination
Percentage of Participants with Seroconversion to Antigens After Vaccination
Seroconversion titer \< 10 (1/dil) on Day 0 and post-injection(s) titer ≥ 40 (1/dil) on Day 28 or Day 56, or titer ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection(s) titer on 28 days post-final vaccination.
Time frame: Day 0 and 28 days post-final vaccination
Geometric Mean Individual Titer Ratio for Participants Aged 65 years or Older
Geometric mean titers will be assessed by an HAI method.
Time frame: Day 0 and 28 days post-final vaccination
Percentage of Participants with Seroconversion to Antigens After Vaccination for Participants Aged 65 years or Older
Seroconversion titer \< 10 (1/dil) on Day 0 and post-injection(s) titer ≥ 40 (1/dil) on Day 28, or titer ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection(s) titer on 28 days post-final vaccination.
Time frame: Day 0 and 28 days post-final vaccination
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