Study of Shenzhen Quadrivalent Inactivated Influenza Vaccine Versus the Shenzhen Trivalent Inactivated Influenza Vaccine in Chinese Subjects From 6 Months of Age
- Conditions
- Influenza
- Interventions
- Biological: Quadrivalent Influenza VaccineBiological: Trivalent Influenza Vaccine 1 SP Shz TIV1Biological: Trivalent Influenza Vaccine 2 SP Shz TIV2
- Registration Number
- NCT04210349
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7106
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3: 9 to 17 years, step 2 Trivalent Influenza Vaccine 2 SP Shz TIV2 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. Group A: 6 to 35 months, previously unvaccinated, step 1 Quadrivalent Influenza Vaccine Participants will receive two injections of SP Shz QIV 0.5 mL at Day 0 and Day 28 Group 1: 6 to 35 months, step 2 Trivalent Influenza Vaccine 1 SP Shz TIV1 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. Group 1: 6 to 35 months, step 2 Trivalent Influenza Vaccine 2 SP Shz TIV2 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. Group 3: 9 to 17 years, step 2 Quadrivalent Influenza Vaccine 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. Group 5: >=61 years Quadrivalent Influenza Vaccine 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. Group 2: 3 to 8 years, step 2 Trivalent Influenza Vaccine 1 SP Shz TIV1 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. Group 4: 18 to 60 years, step 2 Trivalent Influenza Vaccine 2 SP Shz TIV2 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. Group 1: 6 to 35 months, step 2 Quadrivalent Influenza Vaccine 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. Group 2: 3 to 8 years, step 2 Quadrivalent Influenza Vaccine 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. Group 4: 18 to 60 years, step 2 Trivalent Influenza Vaccine 1 SP Shz TIV1 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. Group 5: >=61 years Trivalent Influenza Vaccine 1 SP Shz TIV1 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. Group 2: 3 to 8 years, step 2 Trivalent Influenza Vaccine 2 SP Shz TIV2 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. Group 3: 9 to 17 years, step 2 Trivalent Influenza Vaccine 1 SP Shz TIV1 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. Group 4: 18 to 60 years, step 2 Quadrivalent Influenza Vaccine 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. Group 5: >=61 years Trivalent Influenza Vaccine 2 SP Shz TIV2 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.
- Primary Outcome Measures
Name Time Method Geometric Mean Titers of Influenza Antibodies for Subjects 6-35 months 28 days post-final vaccination Geometric mean titers will be assessed by a hemagglutination (HAI) method
Participants Achieving Seroconversion Against Antigens for Subjects 6-35 months 28 days post-final vaccination Influenza antibodies will be assessed using the HAI method.
Number of Participants with Immediate Adverse Events Within 30 minutes after vaccination Immediate adverse events includes unsolicited systemic adverse events occuring within 30 minutes after vaccination
Number of Participants With Solicited Injection Site or Systemic Reactions Within 7 days after vaccination 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.
Number of Participants with Unsolicited Adverse Events Within 28 days after vaccination Adverse events other than solicited reactions
Number of Participants with Serious Adverse Events 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. Serious adverse events (including adverse event of special interest) are assessed throughout the study.
Geometric Mean Titers of Antibodies for Subjects ≥ 3 years Day 28 Geometric mean titers will be assessed by a HAI method
Number of Participants Achieving Seroconversion Against Antigens for Subjects ≥ 3 years Day 28 Influenza antibodies will be assessed using the HAI method.
- Secondary Outcome Measures
Name Time Method Geometric Mean Titers of Antibodies Day 0 and 28 days post-final vaccination Geometric mean titers will be assessed by a HAI method.
Number of Participants with Detectable Titer ≥ 10 (1/dilution [1/dil]) Day 0 and 28 days post-final vaccination Geometric mean titers will be assessed by an HAI method.
Geometric Mean Individual Titer Ratio Day 0 and 28 days post-final vaccination Geometric mean titers will be assessed by a HAI method.
Percentage of Participants with Seroprotection to Antigens After Vaccination Day 0 and 28 days post-final vaccination Seroprotection was defined as antibody titer ≥ 40 (1/dil) on Day 0 and on 28 days post-final vaccination
Percentage of Participants with Seroconversion to Antigens After Vaccination Day 0 and 28 days post-final 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.
Percentage of Participants with Seroconversion to Antigens After Vaccination for Participants Aged 65 years or Older Day 0 and 28 days post-final vaccination 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.
Geometric Mean Individual Titer Ratio for Participants Aged 65 years or Older Day 0 and 28 days post-final vaccination Geometric mean titers will be assessed by an HAI method.
Trial Locations
- Locations (7)
Investigational Site Number 1561001
🇨🇳Lincang, China
Investigational Site Number 1561003
🇨🇳Lincang, China
Investigational Site Number 1561000
🇨🇳Kunming, China
Investigational Site Number 1562002
🇨🇳Xinxiang, China
Investigational Site Number 1562001
🇨🇳Shangqiu, China
Investigational Site Number 1562000
🇨🇳Zhengzhou, China
Investigational Site Number 1561002
🇨🇳Lincang, China