This was a blind-observer, monocenter, randomized, comparative, Phase IV study designed to evaluate the immunogenicity and safety of the Sanofi Pasteur Shenzhen Trivalent Influenza Vaccine (SP Shz TIV) versus the Trivalent Influenza Vaccine manufactured by Hualan Biological Engineering Inc (Hualan TIV) comparator in healthy Chinese participants aged 18 to 59 years.
This study is designed to demonstrate the non-inferiority of the immune response in terms of geometric mean titers (GMTs) and seroconversion rates for the 3 strains (A/H1N1, A-H3N2, and B) after a single dose of either the SP Shz TIV or Hualan TIV. Vaccine immune responses will be assessed on Day 0 (pre-vaccination) and Day 28 post-vaccination. Solicited reactions will be collected from Day 0 up to Day 7 after vaccination, unsolicited non-serious adverse events (AEs) will be collected from Day 0 up to Day 28 post-vaccination, and serious AEs will be collected from Day 0 up to 6 months post-vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,600
0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0
0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0
Sanofi Pasteur Investigational Site 001
Huai'an, China
Summary of Geometric Mean Titers (GMTs) of Each of the Three Strains of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV
GMTs were assessed using the hemagglutination inhibition (HAI) assay.
Time frame: Day 28 post-vaccination
Percentage of Participants with TIV Seroconversion Following a Single Dose of SP Shz TIV or Hualan TIV
Seroconversion rates were assessed using a HAI assay. Seroconversion was defined as titers \<10 (1/dil) at Day 0 and post-injection titer ≥40 (1/dil) at Day 28, or titer ≥10 (1/dil) at Day 0 and a ≥4-fold increase in titer (1/dil) at Day 28.
Time frame: Day 28 post-vaccination
GMTs of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV
GMTs were assessed using the HAI assay.
Time frame: Day 28 post-vaccination
GMT Ratios of TIV Antibodies Following a Single Dose of SP Shz TIV or Hualan TIV
GMTs were assessed using the HAI assay.
Time frame: Day 28 post-vaccination
Percentage of Participants with TIV Antibody Titers ≥10 (1/dil) Following a Single Dose of SP Shz TIV or Hualan TIV
TIV antibody levels were assessed using the HAI assay.
Time frame: Day 28 post-vaccination
Percentage of Participants with TIV Antibody Titers ≥40 (1/dil) Following a Single Dose of SP Shz TIV or Hualan TIV
TIV antibody levels were assessed using the HAI assay.
Time frame: Day 28 post-vaccination
Percentage of Participants Reporting Solicited Injection site or Systemic Reactions Following a Single Dose of SP Shz TIV or Hualan TIV
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Solicited injection site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering
Time frame: Day 0 up to Day 7 post-vaccination